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Phase II trial: Drug reduces sickle cell ‘pain crises’
An industry-funded phase II trial has shown that high doses of the experimental drug crizanlizumab significantly reduced the number of dangerous “pain crises” in subjects with sickle cell disease.
The median per-year rate of pain crises was 45.3% lower among those who took the high dose of crizanlizumab, compared with the placebo group (P = .01) More than a third of the subjects who took the high dose reported no pain crises during the treatment phase, more than double the rate among the placebo group.
The trial findings were released at the annual meeting of the American Society of Hematology and published simultaneously in the New England Journal of Medicine (doi: 10.1056/NEJMoa1611770).
The American Society of Hematology estimates that 70,000-100,000 people in the United States have sickle cell anemia and some patients are treated with hydroxyurea (Hydrea) are available. According to background material provided in the trial report, however, hydroxyurea has limited value, and some patients still face the prospect of pain crises which can lead to end-organ damage, and early death.
The SUSTAIN trial focuses on pain crises, also known as vaso-occlusive and sickle cell crises, which can occur without warning when sickle cells block blood flow and decrease oxygen delivery.
Researchers led by Kenneth I. Ataga, MB, of the University of North Carolina, Chapel Hill, recruited 198 subjects who had sickle cell disease and who had experienced 2-10 pain crises related to their condition over the past year. They randomly assigned 67 subjects to receive a low 2.5-mg/kg dose of crizanlizumab (also known as SelG1), 66 to a high 5.0-mg/kg dose, and 65 to a placebo. Crizanlizumab is an antibody against the molecule P-selectin, whose up-regulation in certain cells and platelets is thought to contribute to vaso-occlusion and sickle cell pain crises.
All the doses were administered intravenously 14 times over a year at sites in Brazil, the United States, and Jamaica. Risk groups for sickle cell include people of African and South American descent, among groups.
The first two doses were loading doses given at 2-week intervals, and the rest were given at 4-week intervals.
Subjects were aged 16-63 years; the median age was 29 for the two crizanlizumab groups and 26 for the placebo group. The percentage of black subjects ranged from 90% to 94% in each group, and the percentage of female subjects ranged from 52% to 58%.
Some subjects, but not all, were taking hydroxyurea. If they were taking the drug, they needed to have been on it for at least 6 months prior to the trial, and at least the last 3 months at a steady dose. Those who didn’t take hydroxyurea weren’t allowed to start taking it.
The researchers found that the median number of pain crises per year was 1.63 in the high-dose group, 2.01 in the low-dose group, and 2.98 in the placebo group. That translates to a 45.3% lower rate for the high-dose group than placebo (P = .01) and a 32.6% lower rate for low-dose than placebo (P = .18).
A total of 36% of the subjects in the high-dose group had no pain crises during the treatment phase, compared with 18% and 17% in the low-dose and placebo groups, respectively.
In a per-protocol analysis of 125 subjects, the researchers found similar numbers for median pain crises and no pain crises with one exception: The rate of annual pain crises was only 8.3% lower for the low-dose group than the placebo (P = .13).
Overall, the researchers wrote, the rates of adverse and serious adverse events were “similar” among all the subjects regardless of their randomized group.
Five patients died during the trial: two from the high dose group, one in the low dose group, and two in the placebo group. Among serious adverse events, pyrexia and pneumonia occurred more frequently in at least one of the crizanlizumab groups than in the placebo group, but their levels were low at zero to three cases of each event in the three groups.
The researchers noted that they didn’t detect any antibody response against crizanlizumab. However, “longer follow-up and monitoring are necessary to ensure that late neutralizing antibodies do not emerge that might limit the ability to administer crizanlizumab on a long-term basis.”
The study was funded by Selexys Pharmaceuticals, which received grants from the National Heart, Lung, and Blood Institute and the Food and Drug Administration’s Orphan Products Grant Program. Dr. Ataga reports personal fees from Selexys Pharmaceuticals. The other authors report various disclosures or none. The complete list of disclosures is available at NEJM.org.
An industry-funded phase II trial has shown that high doses of the experimental drug crizanlizumab significantly reduced the number of dangerous “pain crises” in subjects with sickle cell disease.
The median per-year rate of pain crises was 45.3% lower among those who took the high dose of crizanlizumab, compared with the placebo group (P = .01) More than a third of the subjects who took the high dose reported no pain crises during the treatment phase, more than double the rate among the placebo group.
The trial findings were released at the annual meeting of the American Society of Hematology and published simultaneously in the New England Journal of Medicine (doi: 10.1056/NEJMoa1611770).
The American Society of Hematology estimates that 70,000-100,000 people in the United States have sickle cell anemia and some patients are treated with hydroxyurea (Hydrea) are available. According to background material provided in the trial report, however, hydroxyurea has limited value, and some patients still face the prospect of pain crises which can lead to end-organ damage, and early death.
The SUSTAIN trial focuses on pain crises, also known as vaso-occlusive and sickle cell crises, which can occur without warning when sickle cells block blood flow and decrease oxygen delivery.
Researchers led by Kenneth I. Ataga, MB, of the University of North Carolina, Chapel Hill, recruited 198 subjects who had sickle cell disease and who had experienced 2-10 pain crises related to their condition over the past year. They randomly assigned 67 subjects to receive a low 2.5-mg/kg dose of crizanlizumab (also known as SelG1), 66 to a high 5.0-mg/kg dose, and 65 to a placebo. Crizanlizumab is an antibody against the molecule P-selectin, whose up-regulation in certain cells and platelets is thought to contribute to vaso-occlusion and sickle cell pain crises.
All the doses were administered intravenously 14 times over a year at sites in Brazil, the United States, and Jamaica. Risk groups for sickle cell include people of African and South American descent, among groups.
The first two doses were loading doses given at 2-week intervals, and the rest were given at 4-week intervals.
Subjects were aged 16-63 years; the median age was 29 for the two crizanlizumab groups and 26 for the placebo group. The percentage of black subjects ranged from 90% to 94% in each group, and the percentage of female subjects ranged from 52% to 58%.
Some subjects, but not all, were taking hydroxyurea. If they were taking the drug, they needed to have been on it for at least 6 months prior to the trial, and at least the last 3 months at a steady dose. Those who didn’t take hydroxyurea weren’t allowed to start taking it.
The researchers found that the median number of pain crises per year was 1.63 in the high-dose group, 2.01 in the low-dose group, and 2.98 in the placebo group. That translates to a 45.3% lower rate for the high-dose group than placebo (P = .01) and a 32.6% lower rate for low-dose than placebo (P = .18).
A total of 36% of the subjects in the high-dose group had no pain crises during the treatment phase, compared with 18% and 17% in the low-dose and placebo groups, respectively.
In a per-protocol analysis of 125 subjects, the researchers found similar numbers for median pain crises and no pain crises with one exception: The rate of annual pain crises was only 8.3% lower for the low-dose group than the placebo (P = .13).
Overall, the researchers wrote, the rates of adverse and serious adverse events were “similar” among all the subjects regardless of their randomized group.
Five patients died during the trial: two from the high dose group, one in the low dose group, and two in the placebo group. Among serious adverse events, pyrexia and pneumonia occurred more frequently in at least one of the crizanlizumab groups than in the placebo group, but their levels were low at zero to three cases of each event in the three groups.
The researchers noted that they didn’t detect any antibody response against crizanlizumab. However, “longer follow-up and monitoring are necessary to ensure that late neutralizing antibodies do not emerge that might limit the ability to administer crizanlizumab on a long-term basis.”
The study was funded by Selexys Pharmaceuticals, which received grants from the National Heart, Lung, and Blood Institute and the Food and Drug Administration’s Orphan Products Grant Program. Dr. Ataga reports personal fees from Selexys Pharmaceuticals. The other authors report various disclosures or none. The complete list of disclosures is available at NEJM.org.
An industry-funded phase II trial has shown that high doses of the experimental drug crizanlizumab significantly reduced the number of dangerous “pain crises” in subjects with sickle cell disease.
The median per-year rate of pain crises was 45.3% lower among those who took the high dose of crizanlizumab, compared with the placebo group (P = .01) More than a third of the subjects who took the high dose reported no pain crises during the treatment phase, more than double the rate among the placebo group.
The trial findings were released at the annual meeting of the American Society of Hematology and published simultaneously in the New England Journal of Medicine (doi: 10.1056/NEJMoa1611770).
The American Society of Hematology estimates that 70,000-100,000 people in the United States have sickle cell anemia and some patients are treated with hydroxyurea (Hydrea) are available. According to background material provided in the trial report, however, hydroxyurea has limited value, and some patients still face the prospect of pain crises which can lead to end-organ damage, and early death.
The SUSTAIN trial focuses on pain crises, also known as vaso-occlusive and sickle cell crises, which can occur without warning when sickle cells block blood flow and decrease oxygen delivery.
Researchers led by Kenneth I. Ataga, MB, of the University of North Carolina, Chapel Hill, recruited 198 subjects who had sickle cell disease and who had experienced 2-10 pain crises related to their condition over the past year. They randomly assigned 67 subjects to receive a low 2.5-mg/kg dose of crizanlizumab (also known as SelG1), 66 to a high 5.0-mg/kg dose, and 65 to a placebo. Crizanlizumab is an antibody against the molecule P-selectin, whose up-regulation in certain cells and platelets is thought to contribute to vaso-occlusion and sickle cell pain crises.
All the doses were administered intravenously 14 times over a year at sites in Brazil, the United States, and Jamaica. Risk groups for sickle cell include people of African and South American descent, among groups.
The first two doses were loading doses given at 2-week intervals, and the rest were given at 4-week intervals.
Subjects were aged 16-63 years; the median age was 29 for the two crizanlizumab groups and 26 for the placebo group. The percentage of black subjects ranged from 90% to 94% in each group, and the percentage of female subjects ranged from 52% to 58%.
Some subjects, but not all, were taking hydroxyurea. If they were taking the drug, they needed to have been on it for at least 6 months prior to the trial, and at least the last 3 months at a steady dose. Those who didn’t take hydroxyurea weren’t allowed to start taking it.
The researchers found that the median number of pain crises per year was 1.63 in the high-dose group, 2.01 in the low-dose group, and 2.98 in the placebo group. That translates to a 45.3% lower rate for the high-dose group than placebo (P = .01) and a 32.6% lower rate for low-dose than placebo (P = .18).
A total of 36% of the subjects in the high-dose group had no pain crises during the treatment phase, compared with 18% and 17% in the low-dose and placebo groups, respectively.
In a per-protocol analysis of 125 subjects, the researchers found similar numbers for median pain crises and no pain crises with one exception: The rate of annual pain crises was only 8.3% lower for the low-dose group than the placebo (P = .13).
Overall, the researchers wrote, the rates of adverse and serious adverse events were “similar” among all the subjects regardless of their randomized group.
Five patients died during the trial: two from the high dose group, one in the low dose group, and two in the placebo group. Among serious adverse events, pyrexia and pneumonia occurred more frequently in at least one of the crizanlizumab groups than in the placebo group, but their levels were low at zero to three cases of each event in the three groups.
The researchers noted that they didn’t detect any antibody response against crizanlizumab. However, “longer follow-up and monitoring are necessary to ensure that late neutralizing antibodies do not emerge that might limit the ability to administer crizanlizumab on a long-term basis.”
The study was funded by Selexys Pharmaceuticals, which received grants from the National Heart, Lung, and Blood Institute and the Food and Drug Administration’s Orphan Products Grant Program. Dr. Ataga reports personal fees from Selexys Pharmaceuticals. The other authors report various disclosures or none. The complete list of disclosures is available at NEJM.org.
FROM ASH 2016
Key clinical point: High-dose crizanlizumab significantly lowers, but does not eliminate, dangerous ‘pain crises’ that strike sickle cell patients.
Major finding: Patients who took high-dose crizanlizumab had a median of 1.63 pain crises a year versus 2.98 for the placebo group. (P = .01)
Data source: A phase II, 12-month, multicenter, double-blind, randomized, placebo-controlled study of 198 patients with sickle cell disease; 129 subjects completed the trial.
Disclosures: The study was funded by Selexys Pharmaceuticals, which received grants from the National Heart, Lung, and Blood Institute and the FDA’s Orphan Products Grant Program. Dr. Ataga reports personal fees from Selexys Pharmaceuticals. The other authors report various disclosures or none. The complete list of disclosures is available at NEJM.org.
Empagliflozin first antidiabetes drug to gain cardioprotective indication
Empagliflozin is the first antidiabetes medication to be approved for reducing the risk of cardiovascular death in patients with type 2 diabetes and concomitant cardiovascular disease.
The Food and Drug Administration granted the new indication based on the EMPA-REG OUTCOME study, a postmarketing analysis that found that empagliflozin (Jardiance, Boehringer-Ingelheim) reduced the risk of cardiovascular death by 38% when added to standard-of-care type 2 diabetes therapy.
When empagliflozin was approved for type 2 diabetes in 2014, the FDA required an additional postmarketing study to examine its cardiovascular safety. The 48-month, open-label EMPA-REG enrolled more than 7,000 patients who had type 2 diabetes and a high risk of cardiovascular disease.
The study’s big surprise, however, was not empagliflozin’s safety, but its striking cardioprotective qualities. It reduced by 14% the risk of the primary endpoint, a composite of cardiovascular death, nonfatal stroke, and nonfatal myocardial infarction (N Engl J Med. 2015;373:2117-28).
When examined as individual outcomes in a secondary analysis, empagliflozin significantly reduced the risk of cardiovascular death by 38%. However, risk reductions on the other endpoints were not significant. Nevertheless, experts called empagliflozin’s cardiovascular benefit a potential game-changer for the clinical challenge of managing patients with both disorders.
But the drug barely squeaked by its June FDA approval hearing for the cardioprotective indication, receiving a split 12-11 endorsement from the Endocrinologic and Metabolic Drugs Advisory Committee. The major sticking point was that EMPA-REG was a test of empagliflozin’s cardiovascular safety, not its efficacy, and that cardiovascular death was not a prespecified endpoint.
Although there were no significant cardiovascular safety issues, empagliflozin has been associated with hypotension, serious urinary tract infection, acute kidney injury, and genital infections.
“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” Jean-Marc Guettier, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, wrote in a press statement. “Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes.”
[email protected]
On Twitter @alz_gal
Empagliflozin is the first antidiabetes medication to be approved for reducing the risk of cardiovascular death in patients with type 2 diabetes and concomitant cardiovascular disease.
The Food and Drug Administration granted the new indication based on the EMPA-REG OUTCOME study, a postmarketing analysis that found that empagliflozin (Jardiance, Boehringer-Ingelheim) reduced the risk of cardiovascular death by 38% when added to standard-of-care type 2 diabetes therapy.
When empagliflozin was approved for type 2 diabetes in 2014, the FDA required an additional postmarketing study to examine its cardiovascular safety. The 48-month, open-label EMPA-REG enrolled more than 7,000 patients who had type 2 diabetes and a high risk of cardiovascular disease.
The study’s big surprise, however, was not empagliflozin’s safety, but its striking cardioprotective qualities. It reduced by 14% the risk of the primary endpoint, a composite of cardiovascular death, nonfatal stroke, and nonfatal myocardial infarction (N Engl J Med. 2015;373:2117-28).
When examined as individual outcomes in a secondary analysis, empagliflozin significantly reduced the risk of cardiovascular death by 38%. However, risk reductions on the other endpoints were not significant. Nevertheless, experts called empagliflozin’s cardiovascular benefit a potential game-changer for the clinical challenge of managing patients with both disorders.
But the drug barely squeaked by its June FDA approval hearing for the cardioprotective indication, receiving a split 12-11 endorsement from the Endocrinologic and Metabolic Drugs Advisory Committee. The major sticking point was that EMPA-REG was a test of empagliflozin’s cardiovascular safety, not its efficacy, and that cardiovascular death was not a prespecified endpoint.
Although there were no significant cardiovascular safety issues, empagliflozin has been associated with hypotension, serious urinary tract infection, acute kidney injury, and genital infections.
“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” Jean-Marc Guettier, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, wrote in a press statement. “Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes.”
[email protected]
On Twitter @alz_gal
Empagliflozin is the first antidiabetes medication to be approved for reducing the risk of cardiovascular death in patients with type 2 diabetes and concomitant cardiovascular disease.
The Food and Drug Administration granted the new indication based on the EMPA-REG OUTCOME study, a postmarketing analysis that found that empagliflozin (Jardiance, Boehringer-Ingelheim) reduced the risk of cardiovascular death by 38% when added to standard-of-care type 2 diabetes therapy.
When empagliflozin was approved for type 2 diabetes in 2014, the FDA required an additional postmarketing study to examine its cardiovascular safety. The 48-month, open-label EMPA-REG enrolled more than 7,000 patients who had type 2 diabetes and a high risk of cardiovascular disease.
The study’s big surprise, however, was not empagliflozin’s safety, but its striking cardioprotective qualities. It reduced by 14% the risk of the primary endpoint, a composite of cardiovascular death, nonfatal stroke, and nonfatal myocardial infarction (N Engl J Med. 2015;373:2117-28).
When examined as individual outcomes in a secondary analysis, empagliflozin significantly reduced the risk of cardiovascular death by 38%. However, risk reductions on the other endpoints were not significant. Nevertheless, experts called empagliflozin’s cardiovascular benefit a potential game-changer for the clinical challenge of managing patients with both disorders.
But the drug barely squeaked by its June FDA approval hearing for the cardioprotective indication, receiving a split 12-11 endorsement from the Endocrinologic and Metabolic Drugs Advisory Committee. The major sticking point was that EMPA-REG was a test of empagliflozin’s cardiovascular safety, not its efficacy, and that cardiovascular death was not a prespecified endpoint.
Although there were no significant cardiovascular safety issues, empagliflozin has been associated with hypotension, serious urinary tract infection, acute kidney injury, and genital infections.
“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” Jean-Marc Guettier, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, wrote in a press statement. “Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes.”
[email protected]
On Twitter @alz_gal
U.S. okay looms for third drug-coated PAD balloon
WASHINGTON – Good pivotal-trial performance of a drug-coated balloon for treating superficial femoral and popliteal artery stenoses raised the prospect that it might soon be the third drug-coated balloon on the U.S. market, creating an opportunity for lower prices and competitive improvements for an increasingly used device.
“Having another drug-coated balloon would be useful for several reasons,” commented William A. Gray, MD, during the Transcatheter Cardiovascular Therapeutics annual meeting. The competition should mean lower cost, and accumulating reports on performance might identify a specific drug-coated balloon as most effective. Drug-coated balloons for peripheral artery stenoses “have been introduced over the past 2 years, with a significant increase in use during that time. It’s still not a majority of patients, but it’s increasing,” said Dr. Gray, chief of the division of cardiovascular disease at Main Line Health and president of Main Line Health’s Lankenau Heart Institute in Wynnewood, Pa.
The ILLUMENATE pivotal trial enrolled 300 patients at 43 centers in the United States and Europe. Patients had Rutherford 2, 3 or 4 disease, and averaged about 69 years old. More than 60% had class 3 disease and another 30% had class 2 disease.
The study’s primary safety endpoint was freedom from device- or procedure-related death to 30 days, and freedom from clinically drived target lesion revascularization at 12 months, a 92% rate in the 200 patients who had PTA with the Stellarex drug-coated balloon and 83% in the 100 controls who had PTA with an uncoated balloon. This statistically significant eight percentage point difference met the prespecified criteria for safety superiority.
The two drug-coated balloons already approved for U.S. use are the Lutonix and the IN.PACT Admiral.
“All the drug-coated balloons have worked well. It’s pretty exciting to see them work. It will be interesting to compare them against each other. We need side-by-side comparisons,” commented Craig M. Walker, MD, an interventional cardiologist in Houma, La. and a discussant for Dr. Lyden’s report.
The ILLUMENATE Pivotal trial was funded by Spectranetics, the company that is developing the Stellarex drug-coated balloon. Dr. Lyden has been a consultant to Spectranetics and to Biomet, Endologix, and TVA Medical. He received research support from Spectranetics and several other companies. Dr. Gray has been a consultant to Abbott Vascular, Boston Scientific, Cook, Medtronic, and Shockwave. He has received research support from Gore and Intact Vascular. Dr. Walker has been a consultant to Spectranetics as well as to Abbott Vascular, Bard, Boston Scientific, Cook, Gore, and Medtronic.
[email protected]
On Twitter @mitchelzoler
It’s good to have competition among various models of drug-eluting balloons because it will help drive costs down and help drive additional improvements in device design. We win by having a third good drug-coated balloon option available.
Drug-coated balloons are increasingly used in routine U.S. practice. A recent report showed that one of the drug-coated balloons already on the U.S. market outperformed balloon angioplasty out to 3 years of follow-up. Drug-coated balloons hold an advantage over stents by leaving nothing behind. Another attraction of drug-coated balloons is that they can potentially be used as an adjunct to additional interventions for complex lesions, such as atherectomy.
So far, we have not seen a clear winner for safety and efficacy among the two drug-coated balloons already on the U.S. market and this new drug-coated balloon, which may soon be the third option for U.S. practice. But there is no single class effect from these drug-coated balloons; they must be evaluated individually.
D. Christopher Metzger, MD, is an interventional cardiologist and director of cardiac and peripheral vascular catheterization labs at the Wellmont CVA Heart Institute in Kingsport, Tenn. He has been a consultant to and received honoraria from Abbott Vascular, Bard, and Medtronic. He made these comments in an interview.
It’s good to have competition among various models of drug-eluting balloons because it will help drive costs down and help drive additional improvements in device design. We win by having a third good drug-coated balloon option available.
Drug-coated balloons are increasingly used in routine U.S. practice. A recent report showed that one of the drug-coated balloons already on the U.S. market outperformed balloon angioplasty out to 3 years of follow-up. Drug-coated balloons hold an advantage over stents by leaving nothing behind. Another attraction of drug-coated balloons is that they can potentially be used as an adjunct to additional interventions for complex lesions, such as atherectomy.
So far, we have not seen a clear winner for safety and efficacy among the two drug-coated balloons already on the U.S. market and this new drug-coated balloon, which may soon be the third option for U.S. practice. But there is no single class effect from these drug-coated balloons; they must be evaluated individually.
D. Christopher Metzger, MD, is an interventional cardiologist and director of cardiac and peripheral vascular catheterization labs at the Wellmont CVA Heart Institute in Kingsport, Tenn. He has been a consultant to and received honoraria from Abbott Vascular, Bard, and Medtronic. He made these comments in an interview.
It’s good to have competition among various models of drug-eluting balloons because it will help drive costs down and help drive additional improvements in device design. We win by having a third good drug-coated balloon option available.
Drug-coated balloons are increasingly used in routine U.S. practice. A recent report showed that one of the drug-coated balloons already on the U.S. market outperformed balloon angioplasty out to 3 years of follow-up. Drug-coated balloons hold an advantage over stents by leaving nothing behind. Another attraction of drug-coated balloons is that they can potentially be used as an adjunct to additional interventions for complex lesions, such as atherectomy.
So far, we have not seen a clear winner for safety and efficacy among the two drug-coated balloons already on the U.S. market and this new drug-coated balloon, which may soon be the third option for U.S. practice. But there is no single class effect from these drug-coated balloons; they must be evaluated individually.
D. Christopher Metzger, MD, is an interventional cardiologist and director of cardiac and peripheral vascular catheterization labs at the Wellmont CVA Heart Institute in Kingsport, Tenn. He has been a consultant to and received honoraria from Abbott Vascular, Bard, and Medtronic. He made these comments in an interview.
WASHINGTON – Good pivotal-trial performance of a drug-coated balloon for treating superficial femoral and popliteal artery stenoses raised the prospect that it might soon be the third drug-coated balloon on the U.S. market, creating an opportunity for lower prices and competitive improvements for an increasingly used device.
“Having another drug-coated balloon would be useful for several reasons,” commented William A. Gray, MD, during the Transcatheter Cardiovascular Therapeutics annual meeting. The competition should mean lower cost, and accumulating reports on performance might identify a specific drug-coated balloon as most effective. Drug-coated balloons for peripheral artery stenoses “have been introduced over the past 2 years, with a significant increase in use during that time. It’s still not a majority of patients, but it’s increasing,” said Dr. Gray, chief of the division of cardiovascular disease at Main Line Health and president of Main Line Health’s Lankenau Heart Institute in Wynnewood, Pa.
The ILLUMENATE pivotal trial enrolled 300 patients at 43 centers in the United States and Europe. Patients had Rutherford 2, 3 or 4 disease, and averaged about 69 years old. More than 60% had class 3 disease and another 30% had class 2 disease.
The study’s primary safety endpoint was freedom from device- or procedure-related death to 30 days, and freedom from clinically drived target lesion revascularization at 12 months, a 92% rate in the 200 patients who had PTA with the Stellarex drug-coated balloon and 83% in the 100 controls who had PTA with an uncoated balloon. This statistically significant eight percentage point difference met the prespecified criteria for safety superiority.
The two drug-coated balloons already approved for U.S. use are the Lutonix and the IN.PACT Admiral.
“All the drug-coated balloons have worked well. It’s pretty exciting to see them work. It will be interesting to compare them against each other. We need side-by-side comparisons,” commented Craig M. Walker, MD, an interventional cardiologist in Houma, La. and a discussant for Dr. Lyden’s report.
The ILLUMENATE Pivotal trial was funded by Spectranetics, the company that is developing the Stellarex drug-coated balloon. Dr. Lyden has been a consultant to Spectranetics and to Biomet, Endologix, and TVA Medical. He received research support from Spectranetics and several other companies. Dr. Gray has been a consultant to Abbott Vascular, Boston Scientific, Cook, Medtronic, and Shockwave. He has received research support from Gore and Intact Vascular. Dr. Walker has been a consultant to Spectranetics as well as to Abbott Vascular, Bard, Boston Scientific, Cook, Gore, and Medtronic.
[email protected]
On Twitter @mitchelzoler
WASHINGTON – Good pivotal-trial performance of a drug-coated balloon for treating superficial femoral and popliteal artery stenoses raised the prospect that it might soon be the third drug-coated balloon on the U.S. market, creating an opportunity for lower prices and competitive improvements for an increasingly used device.
“Having another drug-coated balloon would be useful for several reasons,” commented William A. Gray, MD, during the Transcatheter Cardiovascular Therapeutics annual meeting. The competition should mean lower cost, and accumulating reports on performance might identify a specific drug-coated balloon as most effective. Drug-coated balloons for peripheral artery stenoses “have been introduced over the past 2 years, with a significant increase in use during that time. It’s still not a majority of patients, but it’s increasing,” said Dr. Gray, chief of the division of cardiovascular disease at Main Line Health and president of Main Line Health’s Lankenau Heart Institute in Wynnewood, Pa.
The ILLUMENATE pivotal trial enrolled 300 patients at 43 centers in the United States and Europe. Patients had Rutherford 2, 3 or 4 disease, and averaged about 69 years old. More than 60% had class 3 disease and another 30% had class 2 disease.
The study’s primary safety endpoint was freedom from device- or procedure-related death to 30 days, and freedom from clinically drived target lesion revascularization at 12 months, a 92% rate in the 200 patients who had PTA with the Stellarex drug-coated balloon and 83% in the 100 controls who had PTA with an uncoated balloon. This statistically significant eight percentage point difference met the prespecified criteria for safety superiority.
The two drug-coated balloons already approved for U.S. use are the Lutonix and the IN.PACT Admiral.
“All the drug-coated balloons have worked well. It’s pretty exciting to see them work. It will be interesting to compare them against each other. We need side-by-side comparisons,” commented Craig M. Walker, MD, an interventional cardiologist in Houma, La. and a discussant for Dr. Lyden’s report.
The ILLUMENATE Pivotal trial was funded by Spectranetics, the company that is developing the Stellarex drug-coated balloon. Dr. Lyden has been a consultant to Spectranetics and to Biomet, Endologix, and TVA Medical. He received research support from Spectranetics and several other companies. Dr. Gray has been a consultant to Abbott Vascular, Boston Scientific, Cook, Medtronic, and Shockwave. He has received research support from Gore and Intact Vascular. Dr. Walker has been a consultant to Spectranetics as well as to Abbott Vascular, Bard, Boston Scientific, Cook, Gore, and Medtronic.
[email protected]
On Twitter @mitchelzoler
Key clinical point:
Major finding: The primary efficacy endpoint occurred in 76% of patients in the drug-coated balloon arm and 58% of controls.
Data source: The ILLUMENATE pivotal trial, which enrolled 300 patients at 63 U.S. and European centers.
Disclosures: The ILLUMENATE pivotal trial was funded by Spectranetics, the company that is developing the Stellarex drug-coated balloon. Dr. Lyden has been a consultant to Spectranetics and to Biomet, Endologix, and TVA Medical. He received research support from Spectranetics and several other companies. Dr. Gray has been a consultant to Abbott Vascular, Boston Scientific, Cook, Medtronic, and Shockwave. He has received research support from Gore and Intact Vascular. Dr. Walker has been a consultant to Spectranetics as well as to Abbott Vascular, Bard, Boston Scientific, Cook, Gore, and Medtronic.
Thyme
Native to the western Mediterranean, Thymus vulgaris (one of approximately 300 Thymus species) is a small bush used for centuries as a spice and in medicine, particularly to treat bronchitis.1Thymus species are among the wild and cultivated species used in traditional medicine in Bosnia and Herzegovina for various indications, including skin disorders.2 Thyme essential oil is a natural compound generally recognized as safe by the Food and Drug Administration, with demonstrated antibacterial, antifungal, and antispasmodic activities.3,4 Several other biologic activities have been associated with the polyphenol-rich herb, many of which have dermatologic implications. Notably, the essential oil of thyme and thymol, a key constituent of thyme, are known to act as skin sensitizers and allergens.5
Photoprotective activity
Recently, Sun et al. showed that UVB-induced skin damage was attenuated by treating hairless mice (HR-1) with T. vulgaris, as indicated by reduced matrix metalloproteinases and elevated collagen synthesis. In cultured normal human dermal fibroblasts, the investigators found that T. vulgaris blocked UVB-induced reactive oxygen species and lactate dehydrogenase, and dose-dependently yielded increases in glutathione, NAD(P)H: quinone oxidoreductase 1, and heme oxygenase-1. Further, the botanical significantly reduced UVB-induced phosphorylation of mitogen-activated protein kinases. The investigators concluded that T. vulgaris has potential for use in preventing skin damage caused by UV radiation–induced oxidative stress.6
Thyme also was demonstrated by Cornaghi et al. in 2016 to exert a protective effect on normal human skin explants obtained from seven young healthy women that were treated 1 hour before UVB irradiation.7
In 2015, Calò et al. evaluated the protective effects of a dry extract from T. vulgaris and its primary synthetic constituent thymol against UVA- and UVB-induced oxidative and genotoxic damage in the keratinocyte cell line NCTC 2544. Both thymol and T. vulgaris suppressed reactive oxygen species production in UVA- and UVB-treated cells, but lowered malondialdehyde synthesis only in cells treated with UVA.8
Antioxidant activity
In 2007, Wei and Shibamoto reported that thyme essential oil mixed with clove oil exhibited over a 90% inhibitory effect against the formation of malondialdehyde. They speculated that the presence of thymol and eugenol might account for the strong antioxidant activity displayed by the thyme/clove leaf combination.9 The investigators previously observed antioxidant activities exhibited by volatile extracts isolated from thyme (as well as various other herbs and spices) using aldehyde/carboxylic acid as well as conjugated diene assays.10 The antioxidant activity of thyme also was demonstrated by Miura et al. using the oil stability index method.11
Antimicrobial activity
In 2011, Sienkiewicz et al. reported that the oil of T. vulgaris displayed potent activity against clinical bacterial strains of Staphylococcus, Enterococcus, Escherichia, and Pseudomonas genera. In addition, thyme essential oil exhibited efficacy against tested antibiotic-resistant strains of bacteria.12 The following year, Sienkiewicz et al. assessed the antimicrobial activity of thyme essential oil against clinical multidrug-resistant strains of Staphylococcus, Enterococcus, Escherichia, and Pseudomonas, finding that it potently suppressed the growth of each.13
Potential cutaneous indications: atopic dermatitis, leishmaniasis, eczema, hair growth
In 2015, Seo and Jeong showed that lavender oil, thyme oil, and a blend of the two were all effective in reducing the symptoms of atopic dermatitis in mice. The researchers suggested that developing treatments with these oils for human patients with atopic dermatitis is warranted.14
Nilforoushzadeh et al. found in 2008 that herbal extracts of T. vulgaris and Achillea millefolium (yarrow), as well as propolis hydroalcoholic extracts, were effective in treating cutaneous leishmaniasis in mice and recommended the study of these extracts alone or in combination in human trials.15
A two-arm, randomized, double-blind, placebo-controlled trial conducted by Shimelis et al. in 2012 evaluated the efficacy of a 3% thyme essential oil antifungal cream and a 10% chamomile extract cream in the treatment of eczemalike lesions. Complete healing was achieved in 10 patients (66.5%) treated with the thyme cream, compared with four patients (28.5%) in the placebo group. Although no significant differences were observed between the active chamomile group and placebo, an appreciable number of subjects improved or healed. The investigators concluded that their findings from this small study suggest that, while more research is needed, a 3% thyme essential oil cream appears to be an inexpensive and readily available option to treat mild to moderate cutaneous conditions, including fungal infections, pityriasis alba, and eczema.16
In 2013, Rastegar et al. found that the combination of herbal extracts (including thyme) and platelet-rich plasma induced significant proliferation of human dermal papilla cells by regulating extracellular signal-regulated kinase (ERK) and Akt (protein kinase B). They concluded that their findings suggest the potential for developing combination therapies intended to improve hair growth.17
Insect repellent activity
In a 2016 study by Gutiérrez et al., the essential oil of T. vulgaris was found to be effective against Pediculus humanus capitis (head lice) adults and eggs. The researchers concluded that T. vulgaris achieves a strong knockdown and mortality rate in adult head lice and toxicity in the eggs after 21 minutes of application at a low concentration.18
In a small 1999 study by Barnard of the repellency to Aedes aegypti and Anopheles albimanus of various concentrations and combinations of five essential oils (Bourbon geranium, cedarwood, clove, peppermint, and thyme) applied to human skin, thyme and clove oils were found to be the most effective mosquito repellents. The author noted that thyme oil (as well as clove and peppermint oils) can irritate the skin and the odor of thyme and clove oils, at concentrations of 25%, or more were deemed unacceptable by the two participants in the study.19
Three years later, Choi et al. found that the essential oil of T. vulgaris also repelled adult mosquitoes (Culex pipiens pallens) on hairless mice and displayed potent repellent activity.20
Melanoma
In 2005, Carrera et al. reported a case of long-term complete remission of cutaneous melanoma metastases in a 73-year-old white woman who consumed a dried thyme herbal tea and thyme topical applications in compresses.4 An association between thyme and melanoma has not been reported in the subsequent literature.
Conclusion
Thyme has a long history of culinary and medical uses. Its antimicrobial and antioxidant activity are well documented. While there is reason to consider the potential applications of thyme for dermatologic conditions, much more research is necessary to determine its viability for such purposes.
References
1. An Illustrated Guide to 101 Medicinal Herbs: Their History, Use, Recommended Dosages, and Cautions (Loveland, Colo.: Interweave Press, 1998, pp. 198-9).
2. J Ethnopharmacol. 2010 Aug 19;131(1):33-55.
3. J Food Sci. 2014 May;79(5):M903-10.
4. J Am Acad Dermatol. 2005 Apr;52(4):713-5.
5. Nat Neurosci. 2006 May;9(5):628-35.
6. J Cell Mol Med. 2016 Sep 19. doi: 10.1111/jcmm.12968. [Epub ahead of print]
7. Cells Tissues Organs. 2016;201(3):180-92.
8. Mutat Res Genet Toxicol Environ Mutagen. 2015 Sep;791:30-7.
9. Cutan Ocul Toxicol. 2007;26(3):227-33.
10. J Agric Food Chem. 2002 Aug 14;50(17):4947-52.
11. J Agric Food Chem. 2002 Mar 27;50(7):1845-51.
12. Med Chem. 2011 Nov;7(6):674-89.
13. Microb Drug Resist. 2012 Apr;18(2):137-48.
14. J Korean Acad Nurs. 2015 Jun;45(3):367-77.
15. J Vector Borne Dis. 2008 Dec;45(4):301-6.
16. Int J Dermatol. 2012 Jul;51(7):790-5.
17. J Cosmet Dermatol. 2013 Jun;12(2):116-22.
18. Parasitol Res. 2016 Feb;115(2):633-41.
19. J Med Entomol. 1999 Sep;36(5):625-9.
20. J Am Mosq Control Assoc. 2002 Dec;18(4):348-51.
Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “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,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. Dr. Baumann also developed and owns the Baumann Skin Type Solution skin typing systems and related products.
Native to the western Mediterranean, Thymus vulgaris (one of approximately 300 Thymus species) is a small bush used for centuries as a spice and in medicine, particularly to treat bronchitis.1Thymus species are among the wild and cultivated species used in traditional medicine in Bosnia and Herzegovina for various indications, including skin disorders.2 Thyme essential oil is a natural compound generally recognized as safe by the Food and Drug Administration, with demonstrated antibacterial, antifungal, and antispasmodic activities.3,4 Several other biologic activities have been associated with the polyphenol-rich herb, many of which have dermatologic implications. Notably, the essential oil of thyme and thymol, a key constituent of thyme, are known to act as skin sensitizers and allergens.5
Photoprotective activity
Recently, Sun et al. showed that UVB-induced skin damage was attenuated by treating hairless mice (HR-1) with T. vulgaris, as indicated by reduced matrix metalloproteinases and elevated collagen synthesis. In cultured normal human dermal fibroblasts, the investigators found that T. vulgaris blocked UVB-induced reactive oxygen species and lactate dehydrogenase, and dose-dependently yielded increases in glutathione, NAD(P)H: quinone oxidoreductase 1, and heme oxygenase-1. Further, the botanical significantly reduced UVB-induced phosphorylation of mitogen-activated protein kinases. The investigators concluded that T. vulgaris has potential for use in preventing skin damage caused by UV radiation–induced oxidative stress.6
Thyme also was demonstrated by Cornaghi et al. in 2016 to exert a protective effect on normal human skin explants obtained from seven young healthy women that were treated 1 hour before UVB irradiation.7
In 2015, Calò et al. evaluated the protective effects of a dry extract from T. vulgaris and its primary synthetic constituent thymol against UVA- and UVB-induced oxidative and genotoxic damage in the keratinocyte cell line NCTC 2544. Both thymol and T. vulgaris suppressed reactive oxygen species production in UVA- and UVB-treated cells, but lowered malondialdehyde synthesis only in cells treated with UVA.8
Antioxidant activity
In 2007, Wei and Shibamoto reported that thyme essential oil mixed with clove oil exhibited over a 90% inhibitory effect against the formation of malondialdehyde. They speculated that the presence of thymol and eugenol might account for the strong antioxidant activity displayed by the thyme/clove leaf combination.9 The investigators previously observed antioxidant activities exhibited by volatile extracts isolated from thyme (as well as various other herbs and spices) using aldehyde/carboxylic acid as well as conjugated diene assays.10 The antioxidant activity of thyme also was demonstrated by Miura et al. using the oil stability index method.11
Antimicrobial activity
In 2011, Sienkiewicz et al. reported that the oil of T. vulgaris displayed potent activity against clinical bacterial strains of Staphylococcus, Enterococcus, Escherichia, and Pseudomonas genera. In addition, thyme essential oil exhibited efficacy against tested antibiotic-resistant strains of bacteria.12 The following year, Sienkiewicz et al. assessed the antimicrobial activity of thyme essential oil against clinical multidrug-resistant strains of Staphylococcus, Enterococcus, Escherichia, and Pseudomonas, finding that it potently suppressed the growth of each.13
Potential cutaneous indications: atopic dermatitis, leishmaniasis, eczema, hair growth
In 2015, Seo and Jeong showed that lavender oil, thyme oil, and a blend of the two were all effective in reducing the symptoms of atopic dermatitis in mice. The researchers suggested that developing treatments with these oils for human patients with atopic dermatitis is warranted.14
Nilforoushzadeh et al. found in 2008 that herbal extracts of T. vulgaris and Achillea millefolium (yarrow), as well as propolis hydroalcoholic extracts, were effective in treating cutaneous leishmaniasis in mice and recommended the study of these extracts alone or in combination in human trials.15
A two-arm, randomized, double-blind, placebo-controlled trial conducted by Shimelis et al. in 2012 evaluated the efficacy of a 3% thyme essential oil antifungal cream and a 10% chamomile extract cream in the treatment of eczemalike lesions. Complete healing was achieved in 10 patients (66.5%) treated with the thyme cream, compared with four patients (28.5%) in the placebo group. Although no significant differences were observed between the active chamomile group and placebo, an appreciable number of subjects improved or healed. The investigators concluded that their findings from this small study suggest that, while more research is needed, a 3% thyme essential oil cream appears to be an inexpensive and readily available option to treat mild to moderate cutaneous conditions, including fungal infections, pityriasis alba, and eczema.16
In 2013, Rastegar et al. found that the combination of herbal extracts (including thyme) and platelet-rich plasma induced significant proliferation of human dermal papilla cells by regulating extracellular signal-regulated kinase (ERK) and Akt (protein kinase B). They concluded that their findings suggest the potential for developing combination therapies intended to improve hair growth.17
Insect repellent activity
In a 2016 study by Gutiérrez et al., the essential oil of T. vulgaris was found to be effective against Pediculus humanus capitis (head lice) adults and eggs. The researchers concluded that T. vulgaris achieves a strong knockdown and mortality rate in adult head lice and toxicity in the eggs after 21 minutes of application at a low concentration.18
In a small 1999 study by Barnard of the repellency to Aedes aegypti and Anopheles albimanus of various concentrations and combinations of five essential oils (Bourbon geranium, cedarwood, clove, peppermint, and thyme) applied to human skin, thyme and clove oils were found to be the most effective mosquito repellents. The author noted that thyme oil (as well as clove and peppermint oils) can irritate the skin and the odor of thyme and clove oils, at concentrations of 25%, or more were deemed unacceptable by the two participants in the study.19
Three years later, Choi et al. found that the essential oil of T. vulgaris also repelled adult mosquitoes (Culex pipiens pallens) on hairless mice and displayed potent repellent activity.20
Melanoma
In 2005, Carrera et al. reported a case of long-term complete remission of cutaneous melanoma metastases in a 73-year-old white woman who consumed a dried thyme herbal tea and thyme topical applications in compresses.4 An association between thyme and melanoma has not been reported in the subsequent literature.
Conclusion
Thyme has a long history of culinary and medical uses. Its antimicrobial and antioxidant activity are well documented. While there is reason to consider the potential applications of thyme for dermatologic conditions, much more research is necessary to determine its viability for such purposes.
References
1. An Illustrated Guide to 101 Medicinal Herbs: Their History, Use, Recommended Dosages, and Cautions (Loveland, Colo.: Interweave Press, 1998, pp. 198-9).
2. J Ethnopharmacol. 2010 Aug 19;131(1):33-55.
3. J Food Sci. 2014 May;79(5):M903-10.
4. J Am Acad Dermatol. 2005 Apr;52(4):713-5.
5. Nat Neurosci. 2006 May;9(5):628-35.
6. J Cell Mol Med. 2016 Sep 19. doi: 10.1111/jcmm.12968. [Epub ahead of print]
7. Cells Tissues Organs. 2016;201(3):180-92.
8. Mutat Res Genet Toxicol Environ Mutagen. 2015 Sep;791:30-7.
9. Cutan Ocul Toxicol. 2007;26(3):227-33.
10. J Agric Food Chem. 2002 Aug 14;50(17):4947-52.
11. J Agric Food Chem. 2002 Mar 27;50(7):1845-51.
12. Med Chem. 2011 Nov;7(6):674-89.
13. Microb Drug Resist. 2012 Apr;18(2):137-48.
14. J Korean Acad Nurs. 2015 Jun;45(3):367-77.
15. J Vector Borne Dis. 2008 Dec;45(4):301-6.
16. Int J Dermatol. 2012 Jul;51(7):790-5.
17. J Cosmet Dermatol. 2013 Jun;12(2):116-22.
18. Parasitol Res. 2016 Feb;115(2):633-41.
19. J Med Entomol. 1999 Sep;36(5):625-9.
20. J Am Mosq Control Assoc. 2002 Dec;18(4):348-51.
Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “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,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. Dr. Baumann also developed and owns the Baumann Skin Type Solution skin typing systems and related products.
Native to the western Mediterranean, Thymus vulgaris (one of approximately 300 Thymus species) is a small bush used for centuries as a spice and in medicine, particularly to treat bronchitis.1Thymus species are among the wild and cultivated species used in traditional medicine in Bosnia and Herzegovina for various indications, including skin disorders.2 Thyme essential oil is a natural compound generally recognized as safe by the Food and Drug Administration, with demonstrated antibacterial, antifungal, and antispasmodic activities.3,4 Several other biologic activities have been associated with the polyphenol-rich herb, many of which have dermatologic implications. Notably, the essential oil of thyme and thymol, a key constituent of thyme, are known to act as skin sensitizers and allergens.5
Photoprotective activity
Recently, Sun et al. showed that UVB-induced skin damage was attenuated by treating hairless mice (HR-1) with T. vulgaris, as indicated by reduced matrix metalloproteinases and elevated collagen synthesis. In cultured normal human dermal fibroblasts, the investigators found that T. vulgaris blocked UVB-induced reactive oxygen species and lactate dehydrogenase, and dose-dependently yielded increases in glutathione, NAD(P)H: quinone oxidoreductase 1, and heme oxygenase-1. Further, the botanical significantly reduced UVB-induced phosphorylation of mitogen-activated protein kinases. The investigators concluded that T. vulgaris has potential for use in preventing skin damage caused by UV radiation–induced oxidative stress.6
Thyme also was demonstrated by Cornaghi et al. in 2016 to exert a protective effect on normal human skin explants obtained from seven young healthy women that were treated 1 hour before UVB irradiation.7
In 2015, Calò et al. evaluated the protective effects of a dry extract from T. vulgaris and its primary synthetic constituent thymol against UVA- and UVB-induced oxidative and genotoxic damage in the keratinocyte cell line NCTC 2544. Both thymol and T. vulgaris suppressed reactive oxygen species production in UVA- and UVB-treated cells, but lowered malondialdehyde synthesis only in cells treated with UVA.8
Antioxidant activity
In 2007, Wei and Shibamoto reported that thyme essential oil mixed with clove oil exhibited over a 90% inhibitory effect against the formation of malondialdehyde. They speculated that the presence of thymol and eugenol might account for the strong antioxidant activity displayed by the thyme/clove leaf combination.9 The investigators previously observed antioxidant activities exhibited by volatile extracts isolated from thyme (as well as various other herbs and spices) using aldehyde/carboxylic acid as well as conjugated diene assays.10 The antioxidant activity of thyme also was demonstrated by Miura et al. using the oil stability index method.11
Antimicrobial activity
In 2011, Sienkiewicz et al. reported that the oil of T. vulgaris displayed potent activity against clinical bacterial strains of Staphylococcus, Enterococcus, Escherichia, and Pseudomonas genera. In addition, thyme essential oil exhibited efficacy against tested antibiotic-resistant strains of bacteria.12 The following year, Sienkiewicz et al. assessed the antimicrobial activity of thyme essential oil against clinical multidrug-resistant strains of Staphylococcus, Enterococcus, Escherichia, and Pseudomonas, finding that it potently suppressed the growth of each.13
Potential cutaneous indications: atopic dermatitis, leishmaniasis, eczema, hair growth
In 2015, Seo and Jeong showed that lavender oil, thyme oil, and a blend of the two were all effective in reducing the symptoms of atopic dermatitis in mice. The researchers suggested that developing treatments with these oils for human patients with atopic dermatitis is warranted.14
Nilforoushzadeh et al. found in 2008 that herbal extracts of T. vulgaris and Achillea millefolium (yarrow), as well as propolis hydroalcoholic extracts, were effective in treating cutaneous leishmaniasis in mice and recommended the study of these extracts alone or in combination in human trials.15
A two-arm, randomized, double-blind, placebo-controlled trial conducted by Shimelis et al. in 2012 evaluated the efficacy of a 3% thyme essential oil antifungal cream and a 10% chamomile extract cream in the treatment of eczemalike lesions. Complete healing was achieved in 10 patients (66.5%) treated with the thyme cream, compared with four patients (28.5%) in the placebo group. Although no significant differences were observed between the active chamomile group and placebo, an appreciable number of subjects improved or healed. The investigators concluded that their findings from this small study suggest that, while more research is needed, a 3% thyme essential oil cream appears to be an inexpensive and readily available option to treat mild to moderate cutaneous conditions, including fungal infections, pityriasis alba, and eczema.16
In 2013, Rastegar et al. found that the combination of herbal extracts (including thyme) and platelet-rich plasma induced significant proliferation of human dermal papilla cells by regulating extracellular signal-regulated kinase (ERK) and Akt (protein kinase B). They concluded that their findings suggest the potential for developing combination therapies intended to improve hair growth.17
Insect repellent activity
In a 2016 study by Gutiérrez et al., the essential oil of T. vulgaris was found to be effective against Pediculus humanus capitis (head lice) adults and eggs. The researchers concluded that T. vulgaris achieves a strong knockdown and mortality rate in adult head lice and toxicity in the eggs after 21 minutes of application at a low concentration.18
In a small 1999 study by Barnard of the repellency to Aedes aegypti and Anopheles albimanus of various concentrations and combinations of five essential oils (Bourbon geranium, cedarwood, clove, peppermint, and thyme) applied to human skin, thyme and clove oils were found to be the most effective mosquito repellents. The author noted that thyme oil (as well as clove and peppermint oils) can irritate the skin and the odor of thyme and clove oils, at concentrations of 25%, or more were deemed unacceptable by the two participants in the study.19
Three years later, Choi et al. found that the essential oil of T. vulgaris also repelled adult mosquitoes (Culex pipiens pallens) on hairless mice and displayed potent repellent activity.20
Melanoma
In 2005, Carrera et al. reported a case of long-term complete remission of cutaneous melanoma metastases in a 73-year-old white woman who consumed a dried thyme herbal tea and thyme topical applications in compresses.4 An association between thyme and melanoma has not been reported in the subsequent literature.
Conclusion
Thyme has a long history of culinary and medical uses. Its antimicrobial and antioxidant activity are well documented. While there is reason to consider the potential applications of thyme for dermatologic conditions, much more research is necessary to determine its viability for such purposes.
References
1. An Illustrated Guide to 101 Medicinal Herbs: Their History, Use, Recommended Dosages, and Cautions (Loveland, Colo.: Interweave Press, 1998, pp. 198-9).
2. J Ethnopharmacol. 2010 Aug 19;131(1):33-55.
3. J Food Sci. 2014 May;79(5):M903-10.
4. J Am Acad Dermatol. 2005 Apr;52(4):713-5.
5. Nat Neurosci. 2006 May;9(5):628-35.
6. J Cell Mol Med. 2016 Sep 19. doi: 10.1111/jcmm.12968. [Epub ahead of print]
7. Cells Tissues Organs. 2016;201(3):180-92.
8. Mutat Res Genet Toxicol Environ Mutagen. 2015 Sep;791:30-7.
9. Cutan Ocul Toxicol. 2007;26(3):227-33.
10. J Agric Food Chem. 2002 Aug 14;50(17):4947-52.
11. J Agric Food Chem. 2002 Mar 27;50(7):1845-51.
12. Med Chem. 2011 Nov;7(6):674-89.
13. Microb Drug Resist. 2012 Apr;18(2):137-48.
14. J Korean Acad Nurs. 2015 Jun;45(3):367-77.
15. J Vector Borne Dis. 2008 Dec;45(4):301-6.
16. Int J Dermatol. 2012 Jul;51(7):790-5.
17. J Cosmet Dermatol. 2013 Jun;12(2):116-22.
18. Parasitol Res. 2016 Feb;115(2):633-41.
19. J Med Entomol. 1999 Sep;36(5):625-9.
20. J Am Mosq Control Assoc. 2002 Dec;18(4):348-51.
Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “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,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. Dr. Baumann also developed and owns the Baumann Skin Type Solution skin typing systems and related products.
Sofosbuvir, daclatasvir combo best treatment for HCV cryoglobulinemia vasculitis
WASHINGTON – A combined regimen of sofosbuvir and daclatasvir is the best option to treat patients with hepatitis C virus infections experiencing cryoglobulinemia vasculitis, according to the findings of a new study presented at the annual meeting of the American College of Rheumatology.
“The HCV cryoglobulinemia vasculitis is a very important vasculitis because it represents 5% of chronically infected HCV patients in the world,” explained David Saadoun, MD, of Sorbonne Universities, Paris. “It’s sometimes a life-threatening vasculitis because patients may develop inflammation [so] there’s a need for very active and well-tolerated treatment.”
The primary endpoint – complete response to treatment at the end of the regimen – was achieved in 91% of subjects by the end of 24 weeks. Furthermore, 50% of patients experienced complete immunological response, defined as the complete clearance of cryoglobulin, within 24 weeks. At 12 weeks, average cryoglobulin levels decreased from 0.36 ± 0.12 to 0.10 ± 0.08 g/L, (P = .019), while average aminotransferase levels decreased from 57.6 ± 7.1 to 20.4 ± 2.0 IU/mL, (P less than .01).
But perhaps most significant, according to Dr. Saadoun, is that less than 5% of subjects required any additional treatment via immunosuppressants, such as steroids or rituximab. Average HCV viral loads dropped from 5.6 to 1.18 IU/mL at week 4 (P less than .01), with similarly sustained results through to week 12, indicating good virological responses. No serious adverse events were reported by any subjects throughout the trial period.
“The limitation is that there are quite a few patients, because it is only 35 patients this time, [and] that it’s a prospective, open-label study with no comparators,” Dr. Saadoun explained, adding that, in terms of further research, “[any] new study would focus on the way to avoid rituximab and steroid use in these patients, and to also have more patients treated with this regimen.”
No funding source was disclosed for this study. Dr. Saadoun did not report any relevant financial disclosures.
WASHINGTON – A combined regimen of sofosbuvir and daclatasvir is the best option to treat patients with hepatitis C virus infections experiencing cryoglobulinemia vasculitis, according to the findings of a new study presented at the annual meeting of the American College of Rheumatology.
“The HCV cryoglobulinemia vasculitis is a very important vasculitis because it represents 5% of chronically infected HCV patients in the world,” explained David Saadoun, MD, of Sorbonne Universities, Paris. “It’s sometimes a life-threatening vasculitis because patients may develop inflammation [so] there’s a need for very active and well-tolerated treatment.”
The primary endpoint – complete response to treatment at the end of the regimen – was achieved in 91% of subjects by the end of 24 weeks. Furthermore, 50% of patients experienced complete immunological response, defined as the complete clearance of cryoglobulin, within 24 weeks. At 12 weeks, average cryoglobulin levels decreased from 0.36 ± 0.12 to 0.10 ± 0.08 g/L, (P = .019), while average aminotransferase levels decreased from 57.6 ± 7.1 to 20.4 ± 2.0 IU/mL, (P less than .01).
But perhaps most significant, according to Dr. Saadoun, is that less than 5% of subjects required any additional treatment via immunosuppressants, such as steroids or rituximab. Average HCV viral loads dropped from 5.6 to 1.18 IU/mL at week 4 (P less than .01), with similarly sustained results through to week 12, indicating good virological responses. No serious adverse events were reported by any subjects throughout the trial period.
“The limitation is that there are quite a few patients, because it is only 35 patients this time, [and] that it’s a prospective, open-label study with no comparators,” Dr. Saadoun explained, adding that, in terms of further research, “[any] new study would focus on the way to avoid rituximab and steroid use in these patients, and to also have more patients treated with this regimen.”
No funding source was disclosed for this study. Dr. Saadoun did not report any relevant financial disclosures.
WASHINGTON – A combined regimen of sofosbuvir and daclatasvir is the best option to treat patients with hepatitis C virus infections experiencing cryoglobulinemia vasculitis, according to the findings of a new study presented at the annual meeting of the American College of Rheumatology.
“The HCV cryoglobulinemia vasculitis is a very important vasculitis because it represents 5% of chronically infected HCV patients in the world,” explained David Saadoun, MD, of Sorbonne Universities, Paris. “It’s sometimes a life-threatening vasculitis because patients may develop inflammation [so] there’s a need for very active and well-tolerated treatment.”
The primary endpoint – complete response to treatment at the end of the regimen – was achieved in 91% of subjects by the end of 24 weeks. Furthermore, 50% of patients experienced complete immunological response, defined as the complete clearance of cryoglobulin, within 24 weeks. At 12 weeks, average cryoglobulin levels decreased from 0.36 ± 0.12 to 0.10 ± 0.08 g/L, (P = .019), while average aminotransferase levels decreased from 57.6 ± 7.1 to 20.4 ± 2.0 IU/mL, (P less than .01).
But perhaps most significant, according to Dr. Saadoun, is that less than 5% of subjects required any additional treatment via immunosuppressants, such as steroids or rituximab. Average HCV viral loads dropped from 5.6 to 1.18 IU/mL at week 4 (P less than .01), with similarly sustained results through to week 12, indicating good virological responses. No serious adverse events were reported by any subjects throughout the trial period.
“The limitation is that there are quite a few patients, because it is only 35 patients this time, [and] that it’s a prospective, open-label study with no comparators,” Dr. Saadoun explained, adding that, in terms of further research, “[any] new study would focus on the way to avoid rituximab and steroid use in these patients, and to also have more patients treated with this regimen.”
No funding source was disclosed for this study. Dr. Saadoun did not report any relevant financial disclosures.
AT THE ACR ANNUAL MEETING
Key clinical point:
Major finding: Of 35 patients, 32 (91%) achieved complete clinical response in 6 months, with less than 5% requiring the use of additional immunosuppressants and none experiencing serious adverse events.
Data source: A prospective, open-label study of 35 patients with cryoglobulinemia vasculitis brought on by HCV infection.
Disclosures: Dr. Saadoun did not report any relevant financial disclosures.
Fecal calprotectin tops CRP as Crohn’s marker
Stool calprotectin correlates with severity of small-bowel Crohn’s disease, as measured against balloon-assisted enteroscopy and computed tomography enterography, according to a review reported in the January issue of Clinical Gastroenterology and Hepatology of 89 patients at Toho University in Chiba, Japan.
Although the correlation was moderate, the findings suggest that fecal calprotectin (FC), with additional work, might turn out to be a good biomarker for tracking small-bowel Crohn’s disease (CD) and its response to tumor necrosis factor blockers. “Currently, it is not widely accepted that FC relates to disease activity in patients with small-intestinal CD,” said investigators led by Tsunetaka Arai of Toho University’s division of gastroenterology and hepatology (Clin Gastroenterol Hepatol. 2016 Aug 23. doi: 10.1016/j.cgh.2016.08.015).
Gastroenterologists need a decent biomarker for small-bowel Crohn’s because old-school endoscopy falls short. Adhesions and strictures block endoscopes, and sometimes scopes simply can’t reach the disease site.
Balloon-assisted enteroscopy (BAE) and computed tomography enterography (CTE) have emerged in recent years as alternatives, but, even so, the need persists for a noninvasive and inexpensive biomarker that’s better than the current standard of C-reactive protein (CRP), which can be thrown off by systemic inflammation, among other problems. The Toho investigators “believe that FC could be a relevant surrogate marker of disease activity in small-bowel CD.” Stool calprotectin paralleled disease activity in their study, while “neither the CDAI [CD activity index] score nor serum CRP showed similar correlation,” they said.
However, elevations in FC – a calcium- and zinc-binding protein released when neutrophils, monocytes, and macrophages inflame the intestinal mucosa – was independent of CD location, which signals the need for further investigation.
Meanwhile, the decent correlation between FC and CTE in the study “should [also] mean that” they could be used together to reliably define mucosal healing. CTE on its own “showed good correlation” with BAE; a CTE score/segment less than 2 [was] associated with endoscopic mucosal healing” on BAE, the investigators said.
The study subjects were an average of 32 years old, and had CD for 9 years; most were men. They had highly active disease at their first endoscopy (average CDAI of 120 points), and an average CRP of 1.09 mg/dL. Twenty-seven patients (30.3%) had small-bowel CD, 50 (56.2%) had ileocolonic CD, and 12 (13.5%) had colonic CD.
They all had endoscopic exams, BAE, and FC stool testing; those with strictures (17) went on to CTE; CTE detected every lesion despite the strictures.
The authors had no conflicts of interest.
Stool calprotectin correlates with severity of small-bowel Crohn’s disease, as measured against balloon-assisted enteroscopy and computed tomography enterography, according to a review reported in the January issue of Clinical Gastroenterology and Hepatology of 89 patients at Toho University in Chiba, Japan.
Although the correlation was moderate, the findings suggest that fecal calprotectin (FC), with additional work, might turn out to be a good biomarker for tracking small-bowel Crohn’s disease (CD) and its response to tumor necrosis factor blockers. “Currently, it is not widely accepted that FC relates to disease activity in patients with small-intestinal CD,” said investigators led by Tsunetaka Arai of Toho University’s division of gastroenterology and hepatology (Clin Gastroenterol Hepatol. 2016 Aug 23. doi: 10.1016/j.cgh.2016.08.015).
Gastroenterologists need a decent biomarker for small-bowel Crohn’s because old-school endoscopy falls short. Adhesions and strictures block endoscopes, and sometimes scopes simply can’t reach the disease site.
Balloon-assisted enteroscopy (BAE) and computed tomography enterography (CTE) have emerged in recent years as alternatives, but, even so, the need persists for a noninvasive and inexpensive biomarker that’s better than the current standard of C-reactive protein (CRP), which can be thrown off by systemic inflammation, among other problems. The Toho investigators “believe that FC could be a relevant surrogate marker of disease activity in small-bowel CD.” Stool calprotectin paralleled disease activity in their study, while “neither the CDAI [CD activity index] score nor serum CRP showed similar correlation,” they said.
However, elevations in FC – a calcium- and zinc-binding protein released when neutrophils, monocytes, and macrophages inflame the intestinal mucosa – was independent of CD location, which signals the need for further investigation.
Meanwhile, the decent correlation between FC and CTE in the study “should [also] mean that” they could be used together to reliably define mucosal healing. CTE on its own “showed good correlation” with BAE; a CTE score/segment less than 2 [was] associated with endoscopic mucosal healing” on BAE, the investigators said.
The study subjects were an average of 32 years old, and had CD for 9 years; most were men. They had highly active disease at their first endoscopy (average CDAI of 120 points), and an average CRP of 1.09 mg/dL. Twenty-seven patients (30.3%) had small-bowel CD, 50 (56.2%) had ileocolonic CD, and 12 (13.5%) had colonic CD.
They all had endoscopic exams, BAE, and FC stool testing; those with strictures (17) went on to CTE; CTE detected every lesion despite the strictures.
The authors had no conflicts of interest.
Stool calprotectin correlates with severity of small-bowel Crohn’s disease, as measured against balloon-assisted enteroscopy and computed tomography enterography, according to a review reported in the January issue of Clinical Gastroenterology and Hepatology of 89 patients at Toho University in Chiba, Japan.
Although the correlation was moderate, the findings suggest that fecal calprotectin (FC), with additional work, might turn out to be a good biomarker for tracking small-bowel Crohn’s disease (CD) and its response to tumor necrosis factor blockers. “Currently, it is not widely accepted that FC relates to disease activity in patients with small-intestinal CD,” said investigators led by Tsunetaka Arai of Toho University’s division of gastroenterology and hepatology (Clin Gastroenterol Hepatol. 2016 Aug 23. doi: 10.1016/j.cgh.2016.08.015).
Gastroenterologists need a decent biomarker for small-bowel Crohn’s because old-school endoscopy falls short. Adhesions and strictures block endoscopes, and sometimes scopes simply can’t reach the disease site.
Balloon-assisted enteroscopy (BAE) and computed tomography enterography (CTE) have emerged in recent years as alternatives, but, even so, the need persists for a noninvasive and inexpensive biomarker that’s better than the current standard of C-reactive protein (CRP), which can be thrown off by systemic inflammation, among other problems. The Toho investigators “believe that FC could be a relevant surrogate marker of disease activity in small-bowel CD.” Stool calprotectin paralleled disease activity in their study, while “neither the CDAI [CD activity index] score nor serum CRP showed similar correlation,” they said.
However, elevations in FC – a calcium- and zinc-binding protein released when neutrophils, monocytes, and macrophages inflame the intestinal mucosa – was independent of CD location, which signals the need for further investigation.
Meanwhile, the decent correlation between FC and CTE in the study “should [also] mean that” they could be used together to reliably define mucosal healing. CTE on its own “showed good correlation” with BAE; a CTE score/segment less than 2 [was] associated with endoscopic mucosal healing” on BAE, the investigators said.
The study subjects were an average of 32 years old, and had CD for 9 years; most were men. They had highly active disease at their first endoscopy (average CDAI of 120 points), and an average CRP of 1.09 mg/dL. Twenty-seven patients (30.3%) had small-bowel CD, 50 (56.2%) had ileocolonic CD, and 12 (13.5%) had colonic CD.
They all had endoscopic exams, BAE, and FC stool testing; those with strictures (17) went on to CTE; CTE detected every lesion despite the strictures.
The authors had no conflicts of interest.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point:
Major finding: A fecal calprotectin cutoff of 215 mcg/g identified mucosal healing with 82.8% sensitivity, 71.4% specificity, and an AUC of 0.81.
Data source: Review of 89 Crohn’s patients
Disclosures: The investigators had no conflicts of interest.
PrEP adoption lagging behind awareness in high-risk population
NEW ORLEANS – Awareness about preexposure prophylaxis (PrEP) is steadily increasing among men who have sex with men at high risk for HIV infection, but that increased knowledge did not translate into greater willingness to take the daily pill nor did it increase engagement in high-risk behaviors.
Using questions from the National HIV Behavioral Surveillance System (NHBS), investigators surveyed men who have sex with men in urban settings in 3-year cycles. Awareness about HIV PrEP, once-daily emtricitabine/tenofovir (Truvada) increased from 21% in 2008 to 28% in 2011 to 46% in 2014.
The increase from 2011 to 2014 was statistically significant (P less than .001). The Food and Drug Administration approved the preventive regimen in 2012.
Increased knowledge did not translate to greater willingness to take the daily pill – which has held steady at about 60% of over time.
The number of men who self-reported as HIV negative and sexually active in the previous 12 months included in the survey varied from 421 in 2008, to 461 in 2011, to 451 in 2014.
For people at elevated risk for HIV infection, PrEP also represents an opportunity to take greater control over behavior, according to a recent review (Curr Opin HIV AIDS. 2016;11:3-9). “When you get people in for counseling or condoms, you give them a sense of control,” said Dr. Krotchko of Denver Health Medical Center.
Most survey respondents said they anticipated they would use condoms just as frequently as before if taking PrEP (82%, 78%, and 78%, in 2008, 2011, and 2014, respectively). Similarly, the majority of respondents anticipated having the same number of sexual partners if taking PrEP (92%, 85%, and 89%). These differences were not statistically significant.
The findings indicate availability of HIV PrEP is not increasing unhealthy behaviors, as some may fear. “Riskier behavior while on PrEP has not been borne out by the literature,” Dr. Krotchko said.
Strengths of the study include directly targeting a high-risk population and identifying those with high-risk behaviors who could benefit from use of HIV PrEP. Self-reported anticipated changes may not reflect future behavior in all cases, a potential limitation, Dr. Krotchko pointed out.
The NHBS survey is funded by the Centers for Disease Control and Prevention. IDWeek 2016 comprises the combined meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
NEW ORLEANS – Awareness about preexposure prophylaxis (PrEP) is steadily increasing among men who have sex with men at high risk for HIV infection, but that increased knowledge did not translate into greater willingness to take the daily pill nor did it increase engagement in high-risk behaviors.
Using questions from the National HIV Behavioral Surveillance System (NHBS), investigators surveyed men who have sex with men in urban settings in 3-year cycles. Awareness about HIV PrEP, once-daily emtricitabine/tenofovir (Truvada) increased from 21% in 2008 to 28% in 2011 to 46% in 2014.
The increase from 2011 to 2014 was statistically significant (P less than .001). The Food and Drug Administration approved the preventive regimen in 2012.
Increased knowledge did not translate to greater willingness to take the daily pill – which has held steady at about 60% of over time.
The number of men who self-reported as HIV negative and sexually active in the previous 12 months included in the survey varied from 421 in 2008, to 461 in 2011, to 451 in 2014.
For people at elevated risk for HIV infection, PrEP also represents an opportunity to take greater control over behavior, according to a recent review (Curr Opin HIV AIDS. 2016;11:3-9). “When you get people in for counseling or condoms, you give them a sense of control,” said Dr. Krotchko of Denver Health Medical Center.
Most survey respondents said they anticipated they would use condoms just as frequently as before if taking PrEP (82%, 78%, and 78%, in 2008, 2011, and 2014, respectively). Similarly, the majority of respondents anticipated having the same number of sexual partners if taking PrEP (92%, 85%, and 89%). These differences were not statistically significant.
The findings indicate availability of HIV PrEP is not increasing unhealthy behaviors, as some may fear. “Riskier behavior while on PrEP has not been borne out by the literature,” Dr. Krotchko said.
Strengths of the study include directly targeting a high-risk population and identifying those with high-risk behaviors who could benefit from use of HIV PrEP. Self-reported anticipated changes may not reflect future behavior in all cases, a potential limitation, Dr. Krotchko pointed out.
The NHBS survey is funded by the Centers for Disease Control and Prevention. IDWeek 2016 comprises the combined meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
NEW ORLEANS – Awareness about preexposure prophylaxis (PrEP) is steadily increasing among men who have sex with men at high risk for HIV infection, but that increased knowledge did not translate into greater willingness to take the daily pill nor did it increase engagement in high-risk behaviors.
Using questions from the National HIV Behavioral Surveillance System (NHBS), investigators surveyed men who have sex with men in urban settings in 3-year cycles. Awareness about HIV PrEP, once-daily emtricitabine/tenofovir (Truvada) increased from 21% in 2008 to 28% in 2011 to 46% in 2014.
The increase from 2011 to 2014 was statistically significant (P less than .001). The Food and Drug Administration approved the preventive regimen in 2012.
Increased knowledge did not translate to greater willingness to take the daily pill – which has held steady at about 60% of over time.
The number of men who self-reported as HIV negative and sexually active in the previous 12 months included in the survey varied from 421 in 2008, to 461 in 2011, to 451 in 2014.
For people at elevated risk for HIV infection, PrEP also represents an opportunity to take greater control over behavior, according to a recent review (Curr Opin HIV AIDS. 2016;11:3-9). “When you get people in for counseling or condoms, you give them a sense of control,” said Dr. Krotchko of Denver Health Medical Center.
Most survey respondents said they anticipated they would use condoms just as frequently as before if taking PrEP (82%, 78%, and 78%, in 2008, 2011, and 2014, respectively). Similarly, the majority of respondents anticipated having the same number of sexual partners if taking PrEP (92%, 85%, and 89%). These differences were not statistically significant.
The findings indicate availability of HIV PrEP is not increasing unhealthy behaviors, as some may fear. “Riskier behavior while on PrEP has not been borne out by the literature,” Dr. Krotchko said.
Strengths of the study include directly targeting a high-risk population and identifying those with high-risk behaviors who could benefit from use of HIV PrEP. Self-reported anticipated changes may not reflect future behavior in all cases, a potential limitation, Dr. Krotchko pointed out.
The NHBS survey is funded by the Centers for Disease Control and Prevention. IDWeek 2016 comprises the combined meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
AT IDWEEK 2016
Key clinical point: Adoption and use of HIV PrEP continues to lag behind studies showing its effectiveness in the high-risk population of men who have sex with men.
Major finding: Despite increasing awareness, willingness to use HIV PrEP among MSM remained steady at about 60% over time in a series of national behavioral health surveys.
Data source: The National HIV Behavioral Surveillance System.
Disclosures: Dr. Krotchko had no relevant disclosures.
Thank You to Our 2016 Peer Reviewers
The editors of Emergency Medicine acknowledge the help of the journal’s editorial board members, other emergency physicians, and colleagues in other specialties who reviewed manuscripts in 2016. On behalf of our readers, who are the beneficiaries of your efforts, we thank you.
Alfred Z. Abuhamad, MD
Department of Obstetrics and Gynecology
Eastern Virginia Medical School
John E. Arbo, MD
Division of Emergency Medicine and Pulmonary Critical Care Medicine
Weill Cornell Medical College, Cornell University
David P. Calfee, MD
Division of Infectious Diseases
Weill Cornell Medical College, Cornell University
Richard M. Cantor, MD, FAAP, FACEP
Emergency Department, Pediatrics
Upstate Medical University
Wallace A. Carter, MD, FACEP
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Sunday Clark, ScD
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Theodore R. Delbridge, MD
Department of Emergency
Medicine East Carolina University, Brody School of Medicine
Joseph J. Fins, MD
Division of Medical Ethics Internal Medicine
Weill Cornell Medical College, Cornell University
Ron W. Flenner, MD
Department of Internal Medicine
Eastern Virginia Medical School
E. John Gallagher, MD
Department of Emergency Medicine
Albert Einstein College of Medicine
Marianne Gausche-Hill, MD
Department of Emergency Medicine
Harbor-UCLA Medical Center
Keith D. Hentel, MD
Department of Radiology
Weill Cornell Medical College, Cornell University
Barry J. Knapp, MD
Department of Emergency Medicine
Eastern Virginia Medical School
Richard I. Lapin, MD
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Anthony C. Mustalish, MD
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Lewis S. Nelson, MD
Department of Emergency Medicine
Rutgers New Jersey Medical School
Debra Perina, MD
Department of Emergency Medicine
University of Virginia, Charlottesville
Constance Peterson, MA
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Shari L. Platt, MD, FAAP
Division of Pediatric Emergency Medicine
Weill Cornell Medical College, Cornell University
Rama B. Rao, MD
Division of Toxicology
Weill Cornell Medical College, Cornell University
Earl J. Reisdorff, MD
Executive Director
American Board of Emergency Medicine
Thomas M. Scalea, MD, FACS, FCCM
Program in Trauma
University of Maryland School of Medicine
Edward J. Schenk, MD
Pulmonary Critical Care Medicine
Weill Cornell Medical College, Cornell University
Christopher K. Schott, MD, MS
Department of Emergency Medicine and Critical Care Medicine
University of Pittsburgh
Adam J Singer, MD
Department of Emergency Medicine
Stony Brook University and Medical Center
Sarah A. Stahmer, MD, FACEP
Division of Emergency Medicine
Duke University Medical Center
Michael E. Stern, MD
Division of Geriatric Emergency Medicine
Weill Cornell Medical College, Cornell University
Susan Stone, MD
Emergency Medicine/Palliative Care
University of California, Los Angeles
Todd Taylor, MD
Department of Emergency Medicine
Emory University School of Medicine
The editors of Emergency Medicine acknowledge the help of the journal’s editorial board members, other emergency physicians, and colleagues in other specialties who reviewed manuscripts in 2016. On behalf of our readers, who are the beneficiaries of your efforts, we thank you.
Alfred Z. Abuhamad, MD
Department of Obstetrics and Gynecology
Eastern Virginia Medical School
John E. Arbo, MD
Division of Emergency Medicine and Pulmonary Critical Care Medicine
Weill Cornell Medical College, Cornell University
David P. Calfee, MD
Division of Infectious Diseases
Weill Cornell Medical College, Cornell University
Richard M. Cantor, MD, FAAP, FACEP
Emergency Department, Pediatrics
Upstate Medical University
Wallace A. Carter, MD, FACEP
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Sunday Clark, ScD
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Theodore R. Delbridge, MD
Department of Emergency
Medicine East Carolina University, Brody School of Medicine
Joseph J. Fins, MD
Division of Medical Ethics Internal Medicine
Weill Cornell Medical College, Cornell University
Ron W. Flenner, MD
Department of Internal Medicine
Eastern Virginia Medical School
E. John Gallagher, MD
Department of Emergency Medicine
Albert Einstein College of Medicine
Marianne Gausche-Hill, MD
Department of Emergency Medicine
Harbor-UCLA Medical Center
Keith D. Hentel, MD
Department of Radiology
Weill Cornell Medical College, Cornell University
Barry J. Knapp, MD
Department of Emergency Medicine
Eastern Virginia Medical School
Richard I. Lapin, MD
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Anthony C. Mustalish, MD
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Lewis S. Nelson, MD
Department of Emergency Medicine
Rutgers New Jersey Medical School
Debra Perina, MD
Department of Emergency Medicine
University of Virginia, Charlottesville
Constance Peterson, MA
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Shari L. Platt, MD, FAAP
Division of Pediatric Emergency Medicine
Weill Cornell Medical College, Cornell University
Rama B. Rao, MD
Division of Toxicology
Weill Cornell Medical College, Cornell University
Earl J. Reisdorff, MD
Executive Director
American Board of Emergency Medicine
Thomas M. Scalea, MD, FACS, FCCM
Program in Trauma
University of Maryland School of Medicine
Edward J. Schenk, MD
Pulmonary Critical Care Medicine
Weill Cornell Medical College, Cornell University
Christopher K. Schott, MD, MS
Department of Emergency Medicine and Critical Care Medicine
University of Pittsburgh
Adam J Singer, MD
Department of Emergency Medicine
Stony Brook University and Medical Center
Sarah A. Stahmer, MD, FACEP
Division of Emergency Medicine
Duke University Medical Center
Michael E. Stern, MD
Division of Geriatric Emergency Medicine
Weill Cornell Medical College, Cornell University
Susan Stone, MD
Emergency Medicine/Palliative Care
University of California, Los Angeles
Todd Taylor, MD
Department of Emergency Medicine
Emory University School of Medicine
The editors of Emergency Medicine acknowledge the help of the journal’s editorial board members, other emergency physicians, and colleagues in other specialties who reviewed manuscripts in 2016. On behalf of our readers, who are the beneficiaries of your efforts, we thank you.
Alfred Z. Abuhamad, MD
Department of Obstetrics and Gynecology
Eastern Virginia Medical School
John E. Arbo, MD
Division of Emergency Medicine and Pulmonary Critical Care Medicine
Weill Cornell Medical College, Cornell University
David P. Calfee, MD
Division of Infectious Diseases
Weill Cornell Medical College, Cornell University
Richard M. Cantor, MD, FAAP, FACEP
Emergency Department, Pediatrics
Upstate Medical University
Wallace A. Carter, MD, FACEP
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Sunday Clark, ScD
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Theodore R. Delbridge, MD
Department of Emergency
Medicine East Carolina University, Brody School of Medicine
Joseph J. Fins, MD
Division of Medical Ethics Internal Medicine
Weill Cornell Medical College, Cornell University
Ron W. Flenner, MD
Department of Internal Medicine
Eastern Virginia Medical School
E. John Gallagher, MD
Department of Emergency Medicine
Albert Einstein College of Medicine
Marianne Gausche-Hill, MD
Department of Emergency Medicine
Harbor-UCLA Medical Center
Keith D. Hentel, MD
Department of Radiology
Weill Cornell Medical College, Cornell University
Barry J. Knapp, MD
Department of Emergency Medicine
Eastern Virginia Medical School
Richard I. Lapin, MD
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Anthony C. Mustalish, MD
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Lewis S. Nelson, MD
Department of Emergency Medicine
Rutgers New Jersey Medical School
Debra Perina, MD
Department of Emergency Medicine
University of Virginia, Charlottesville
Constance Peterson, MA
Department of Emergency Medicine
Weill Cornell Medical College, Cornell University
Shari L. Platt, MD, FAAP
Division of Pediatric Emergency Medicine
Weill Cornell Medical College, Cornell University
Rama B. Rao, MD
Division of Toxicology
Weill Cornell Medical College, Cornell University
Earl J. Reisdorff, MD
Executive Director
American Board of Emergency Medicine
Thomas M. Scalea, MD, FACS, FCCM
Program in Trauma
University of Maryland School of Medicine
Edward J. Schenk, MD
Pulmonary Critical Care Medicine
Weill Cornell Medical College, Cornell University
Christopher K. Schott, MD, MS
Department of Emergency Medicine and Critical Care Medicine
University of Pittsburgh
Adam J Singer, MD
Department of Emergency Medicine
Stony Brook University and Medical Center
Sarah A. Stahmer, MD, FACEP
Division of Emergency Medicine
Duke University Medical Center
Michael E. Stern, MD
Division of Geriatric Emergency Medicine
Weill Cornell Medical College, Cornell University
Susan Stone, MD
Emergency Medicine/Palliative Care
University of California, Los Angeles
Todd Taylor, MD
Department of Emergency Medicine
Emory University School of Medicine
Screening tool spots teens headed for substance-dependent adulthood
VIENNA – The creation of a simple risk score that accurately predicts which adolescents in the general population will develop persistent substance dependence as adults has been one of the highlights of the year in addiction medicine, Wim van den Brink, MD, said at the annual congress of the European College of Neuropsychopharmacology.
“These predictors are not very difficult to assess. Clinicians will be interested to know that the positive predictive value of the screen is threefold greater than the persistent prevalence rate,” noted Dr. van den Brink, professor of psychiatry and addiction at the University of Amsterdam and director of the Amsterdam Institute for Addiction Research.
The New Zealand researchers developed what they call “a universal screening tool” by working backward in an analysis of a representative group of 1,037 individuals born in Dunedin, New Zealand, in 1972-1973 and prospectively followed to age 38 years, with a 95% study retention rate. Along the way, participants were assessed for dependence on alcohol, tobacco, cannabis, or hard drugs at ages 21, 26, 32, and 38.
Persistent substance dependence in adulthood, defined as dependence at a minimum of three of the assessments, was present in 19% of subjects.
The investigators found that the presence in childhood or adolescence of any four of nine risk factors had an area under the curve of 80% for persistent substance dependence as an adult. The sensitivity was 43%, with a 93% specificity. The positive predictive value was 60%, and the negative predictive value was 87% (Psychol Med. 2016 Mar;46[4]:877-89).
The nine risk factors are low family socioeconomic status, a family history of substance dependence, childhood depression, childhood conduct disorder, early exposure to substances, adolescent frequent alcohol use, adolescent frequent cannabis use, male gender, and adolescent frequent tobacco use.
The single least potent predictor was low family socioeconomic status, with an associated 1.73-fold increased risk. The strongest predictors were adolescent frequent tobacco use, which conferred a 5.41-fold increased risk; adolescent frequent cannabis use, with a 4.25-fold risk; and childhood conduct disorder, with a 3.2-fold increased risk.
The investigators also analyzed the screening tool’s performance in predicting a modified outcome consisting of adult persistent dependence on any of the target substances except for tobacco. The predictive power of having any four of the risk factors was similar to that found in the main analysis; however, the two strongest predictors now became adolescent frequent cannabis use, with a 9.5-fold increased risk, and childhood conduct disorder, with a relative risk of 5.42.
Regarding childhood conduct disorder as a risk factor, Dr. van den Brink said, “If you are a child with conduct disorder, your chances of becoming substance dependent in coming years is more than fivefold greater than in a child without conduct disorder.”
This raises the question of whether effective treatment of childhood conduct disorder might prevent later development of persistent substance dependence in adulthood. The answer remains unknown. Although there is no approved drug therapy for conduct disorder, methylphenidate is widely prescribed, especially in young patients with comorbid attention-deficit/hyperactivity disorder.
Several years ago a meta-analysis of 15 longitudinal studies with more than 2,500 participants concluded that stimulant therapy of childhood ADHD neither increased nor reduced the risk of subsequent substance use disorders (JAMA Psychiatry. 2013 Jul;70[7]:740-9). Prescribing physicians were happy to hear they weren’t causing iatrogenic injury, but Dr. van den Brink said he was never comfortable with the investigators’ conclusion.
“There was a lot of heterogeneity in the data, so the overall conclusion might not be the best conclusion,” he said.
He said has become more convinced of that than ever as a result of a recent randomized, double-blind, placebo-controlled MRI study of cerebral blood flow in response to methylphenidate in stimulant-naive patients with childhood or adult AHDH. The investigators found that MRIs obtained 1 week after the conclusion of 16 weeks of methylphenidate therapy showed increased blood flow in the strial and thalamic areas in the pediatric ADHD patients but not in the adults with ADHD (JAMA Psychiatry. 2016 Sep 1;73[9]:955-62).
This is evidence of an age-dependent sustained effect of methylphenidate therapy on dopamine striatal-thalamic circuitry in children that’s not related to the drug’s clinical effects, which were gone after a week off therapy. The question is, Does this effect represent neurotoxicity, or is it an expression of enhanced brain maturation? Dr. van den Brink said he suspects it’s the latter but cannot exclude the former possibility.
VIENNA – The creation of a simple risk score that accurately predicts which adolescents in the general population will develop persistent substance dependence as adults has been one of the highlights of the year in addiction medicine, Wim van den Brink, MD, said at the annual congress of the European College of Neuropsychopharmacology.
“These predictors are not very difficult to assess. Clinicians will be interested to know that the positive predictive value of the screen is threefold greater than the persistent prevalence rate,” noted Dr. van den Brink, professor of psychiatry and addiction at the University of Amsterdam and director of the Amsterdam Institute for Addiction Research.
The New Zealand researchers developed what they call “a universal screening tool” by working backward in an analysis of a representative group of 1,037 individuals born in Dunedin, New Zealand, in 1972-1973 and prospectively followed to age 38 years, with a 95% study retention rate. Along the way, participants were assessed for dependence on alcohol, tobacco, cannabis, or hard drugs at ages 21, 26, 32, and 38.
Persistent substance dependence in adulthood, defined as dependence at a minimum of three of the assessments, was present in 19% of subjects.
The investigators found that the presence in childhood or adolescence of any four of nine risk factors had an area under the curve of 80% for persistent substance dependence as an adult. The sensitivity was 43%, with a 93% specificity. The positive predictive value was 60%, and the negative predictive value was 87% (Psychol Med. 2016 Mar;46[4]:877-89).
The nine risk factors are low family socioeconomic status, a family history of substance dependence, childhood depression, childhood conduct disorder, early exposure to substances, adolescent frequent alcohol use, adolescent frequent cannabis use, male gender, and adolescent frequent tobacco use.
The single least potent predictor was low family socioeconomic status, with an associated 1.73-fold increased risk. The strongest predictors were adolescent frequent tobacco use, which conferred a 5.41-fold increased risk; adolescent frequent cannabis use, with a 4.25-fold risk; and childhood conduct disorder, with a 3.2-fold increased risk.
The investigators also analyzed the screening tool’s performance in predicting a modified outcome consisting of adult persistent dependence on any of the target substances except for tobacco. The predictive power of having any four of the risk factors was similar to that found in the main analysis; however, the two strongest predictors now became adolescent frequent cannabis use, with a 9.5-fold increased risk, and childhood conduct disorder, with a relative risk of 5.42.
Regarding childhood conduct disorder as a risk factor, Dr. van den Brink said, “If you are a child with conduct disorder, your chances of becoming substance dependent in coming years is more than fivefold greater than in a child without conduct disorder.”
This raises the question of whether effective treatment of childhood conduct disorder might prevent later development of persistent substance dependence in adulthood. The answer remains unknown. Although there is no approved drug therapy for conduct disorder, methylphenidate is widely prescribed, especially in young patients with comorbid attention-deficit/hyperactivity disorder.
Several years ago a meta-analysis of 15 longitudinal studies with more than 2,500 participants concluded that stimulant therapy of childhood ADHD neither increased nor reduced the risk of subsequent substance use disorders (JAMA Psychiatry. 2013 Jul;70[7]:740-9). Prescribing physicians were happy to hear they weren’t causing iatrogenic injury, but Dr. van den Brink said he was never comfortable with the investigators’ conclusion.
“There was a lot of heterogeneity in the data, so the overall conclusion might not be the best conclusion,” he said.
He said has become more convinced of that than ever as a result of a recent randomized, double-blind, placebo-controlled MRI study of cerebral blood flow in response to methylphenidate in stimulant-naive patients with childhood or adult AHDH. The investigators found that MRIs obtained 1 week after the conclusion of 16 weeks of methylphenidate therapy showed increased blood flow in the strial and thalamic areas in the pediatric ADHD patients but not in the adults with ADHD (JAMA Psychiatry. 2016 Sep 1;73[9]:955-62).
This is evidence of an age-dependent sustained effect of methylphenidate therapy on dopamine striatal-thalamic circuitry in children that’s not related to the drug’s clinical effects, which were gone after a week off therapy. The question is, Does this effect represent neurotoxicity, or is it an expression of enhanced brain maturation? Dr. van den Brink said he suspects it’s the latter but cannot exclude the former possibility.
VIENNA – The creation of a simple risk score that accurately predicts which adolescents in the general population will develop persistent substance dependence as adults has been one of the highlights of the year in addiction medicine, Wim van den Brink, MD, said at the annual congress of the European College of Neuropsychopharmacology.
“These predictors are not very difficult to assess. Clinicians will be interested to know that the positive predictive value of the screen is threefold greater than the persistent prevalence rate,” noted Dr. van den Brink, professor of psychiatry and addiction at the University of Amsterdam and director of the Amsterdam Institute for Addiction Research.
The New Zealand researchers developed what they call “a universal screening tool” by working backward in an analysis of a representative group of 1,037 individuals born in Dunedin, New Zealand, in 1972-1973 and prospectively followed to age 38 years, with a 95% study retention rate. Along the way, participants were assessed for dependence on alcohol, tobacco, cannabis, or hard drugs at ages 21, 26, 32, and 38.
Persistent substance dependence in adulthood, defined as dependence at a minimum of three of the assessments, was present in 19% of subjects.
The investigators found that the presence in childhood or adolescence of any four of nine risk factors had an area under the curve of 80% for persistent substance dependence as an adult. The sensitivity was 43%, with a 93% specificity. The positive predictive value was 60%, and the negative predictive value was 87% (Psychol Med. 2016 Mar;46[4]:877-89).
The nine risk factors are low family socioeconomic status, a family history of substance dependence, childhood depression, childhood conduct disorder, early exposure to substances, adolescent frequent alcohol use, adolescent frequent cannabis use, male gender, and adolescent frequent tobacco use.
The single least potent predictor was low family socioeconomic status, with an associated 1.73-fold increased risk. The strongest predictors were adolescent frequent tobacco use, which conferred a 5.41-fold increased risk; adolescent frequent cannabis use, with a 4.25-fold risk; and childhood conduct disorder, with a 3.2-fold increased risk.
The investigators also analyzed the screening tool’s performance in predicting a modified outcome consisting of adult persistent dependence on any of the target substances except for tobacco. The predictive power of having any four of the risk factors was similar to that found in the main analysis; however, the two strongest predictors now became adolescent frequent cannabis use, with a 9.5-fold increased risk, and childhood conduct disorder, with a relative risk of 5.42.
Regarding childhood conduct disorder as a risk factor, Dr. van den Brink said, “If you are a child with conduct disorder, your chances of becoming substance dependent in coming years is more than fivefold greater than in a child without conduct disorder.”
This raises the question of whether effective treatment of childhood conduct disorder might prevent later development of persistent substance dependence in adulthood. The answer remains unknown. Although there is no approved drug therapy for conduct disorder, methylphenidate is widely prescribed, especially in young patients with comorbid attention-deficit/hyperactivity disorder.
Several years ago a meta-analysis of 15 longitudinal studies with more than 2,500 participants concluded that stimulant therapy of childhood ADHD neither increased nor reduced the risk of subsequent substance use disorders (JAMA Psychiatry. 2013 Jul;70[7]:740-9). Prescribing physicians were happy to hear they weren’t causing iatrogenic injury, but Dr. van den Brink said he was never comfortable with the investigators’ conclusion.
“There was a lot of heterogeneity in the data, so the overall conclusion might not be the best conclusion,” he said.
He said has become more convinced of that than ever as a result of a recent randomized, double-blind, placebo-controlled MRI study of cerebral blood flow in response to methylphenidate in stimulant-naive patients with childhood or adult AHDH. The investigators found that MRIs obtained 1 week after the conclusion of 16 weeks of methylphenidate therapy showed increased blood flow in the strial and thalamic areas in the pediatric ADHD patients but not in the adults with ADHD (JAMA Psychiatry. 2016 Sep 1;73[9]:955-62).
This is evidence of an age-dependent sustained effect of methylphenidate therapy on dopamine striatal-thalamic circuitry in children that’s not related to the drug’s clinical effects, which were gone after a week off therapy. The question is, Does this effect represent neurotoxicity, or is it an expression of enhanced brain maturation? Dr. van den Brink said he suspects it’s the latter but cannot exclude the former possibility.
EXPERT ANALYSIS FROM THE ECNP CONGRESS
Ocular rosacea remains a stubborn foe
Few skin disorders have the power to devastate lives like ocular rosacea, a painful condition that disrupts vision and can lead to blindness, according to ophthalmologist Edward Wladis, MD.
“Patients really suffer from this diagnosis,” said Dr. Wladis, who practices in Slingerlands, N.Y.
Charles Slonim, MD, an ophthalmologist who practices in Tampa, Fla., put it this way: “We control the condition more than 50 percent of the time, but frequently patients go into periods of remission only to have a recurrence or exacerbation of their ocular rosacea.”
Dr. Wladis coauthored a 2013 report that examined treatments for ocular rosacea, which noted that estimates of the proportion of people with rosacea in the United States who develop ocular rosacea vary, ranging from 58% to 72% (US Ophthalmic Review, 2013;6[2]:86-8).
“Ocular rosacea is one of the subtypes of this disease of cutaneous inflammation,” Dr. Wladis said. “Once the skin becomes so severely inflamed, the glands that lubricate the eye become damaged, and the tear film evaporates rapidly. As a result, patients complain of the effects of a dry ocular surface, and they suffer from blurred vision, tearing, pain, and problems with glare.”
Dr. Slonim suggests that dermatologists refer rosacea patients to an ophthalmologist if they present with any eye symptom, such as dryness, burning, or itching, foreign body sensation in one or both eyes, or chronic redness of either the eyes or the eyelid margins. “They should be seen should be seen by an ophthalmologist to rule out ocular rosacea,” he said. “The ophthalmologist’s ability to look at the eye and eyelids under high magnification – a slit lamp examination – gives us an advantage in the diagnosis of ocular rosacea.”
If these patients do have ocular rosacea, their prognosis is unclear. “Unfortunately, many of our treatments haven’t been carefully vetted,” Dr. Wladis said.
He tends to begin with simpler treatments to heal the ocular surface, such as artificial tears and plugs in the tear drainage ducts to keep tears from leaving the eye quickly. Eyelid scrubs and warm compresses can also be helpful, he said, along with suggestions about lifestyle modifications to avoid the triggers that may exacerbate rosacea.
If those treatments fail, antibiotics are an option.
A 2015 Cochrane Review of studies of rosacea treatments suggested that for treating ocular rosacea, cyclosporine 0.05% ophthalmic emulsion “appeared to be more effective than artificial tears” (Cochrane Database Syst Rev. 2015 Apr 28;[3]:CD003262). And a 2015 study of 38 patients with ocular rosacea concluded that topical cyclosporine was significantly more effective in relieving symptoms and in the treatment of eyelid signs, compared with oral doxycycline (Int J Ophthalmol. 2015 Jun 18;8[3]:544-9).
Antibiotics seem to improve the eyelid’s health, “although some studies have documented that the cornea often doesn’t benefit from antibiotics, and patients’ visual acuity may not improve,” Dr. Wladis said.
Ophthalmologists also may prescribe nonsteroidal and steroidal anti-inflammatory drops, Dr. Slonim added, although “the use of topical ophthalmic steroids do carry the risk of secondary glaucoma with increased intraocular pressures.”
There are even more alternatives. “Dietary modification with omega-3 fatty acids appears to benefit the quality of the tear film,” Dr. Wladis said, referring to the results of a prospective, placebo-controlled, double-blind, randomized trial of patients with dry eye (Int J Ophthalmol. 2013 Dec 18;[6]:811-6). “Intraductal meibomian gland probing and intense pulsed light therapy have both been shown to improve ocular surface–related quality of life, although these treatments are relatively invasive and can rapidly become quite expensive for the patient.”
What’s on the horizon? Researchers have “started to unlock the mysteries of rosacea at the cellular level,” Dr. Wladis said. “Our efforts have recently focused on the cellular changes in the skin of rosacea patients. Using several methods, we assayed the activation of a wide variety of signals within the cells of the skin of these patients and found a consistent elevation of two specific signals.”
The researchers were especially pleased, he said, “that these signals appear to be activated in the outer layers of the skin, meaning that a topical preparation could be developed to selectively suppress these cell signals to turn off the disease without interfering with normal skin structure and function and without the side effects of oral or intravenous medications.”
His team is now working on a topical medication. “Ideally,” he noted, “future clinicians will be able to shift their focus from nonspecific therapies like antibiotics and steroids to really powerful, meaningful cellular therapeutics.”
Dr. Slonim reported no relevant disclosures. Dr. Wladis shares a provisional patent for the use of topical kinase inhibitors in the management of rosacea and recently co-started a biotechnology company called Praxis Biotechnology that aims to develop and test therapies for the condition. He serves as a consultant for both Bausch & Lomb and Valeant Pharmaceuticals.
Few skin disorders have the power to devastate lives like ocular rosacea, a painful condition that disrupts vision and can lead to blindness, according to ophthalmologist Edward Wladis, MD.
“Patients really suffer from this diagnosis,” said Dr. Wladis, who practices in Slingerlands, N.Y.
Charles Slonim, MD, an ophthalmologist who practices in Tampa, Fla., put it this way: “We control the condition more than 50 percent of the time, but frequently patients go into periods of remission only to have a recurrence or exacerbation of their ocular rosacea.”
Dr. Wladis coauthored a 2013 report that examined treatments for ocular rosacea, which noted that estimates of the proportion of people with rosacea in the United States who develop ocular rosacea vary, ranging from 58% to 72% (US Ophthalmic Review, 2013;6[2]:86-8).
“Ocular rosacea is one of the subtypes of this disease of cutaneous inflammation,” Dr. Wladis said. “Once the skin becomes so severely inflamed, the glands that lubricate the eye become damaged, and the tear film evaporates rapidly. As a result, patients complain of the effects of a dry ocular surface, and they suffer from blurred vision, tearing, pain, and problems with glare.”
Dr. Slonim suggests that dermatologists refer rosacea patients to an ophthalmologist if they present with any eye symptom, such as dryness, burning, or itching, foreign body sensation in one or both eyes, or chronic redness of either the eyes or the eyelid margins. “They should be seen should be seen by an ophthalmologist to rule out ocular rosacea,” he said. “The ophthalmologist’s ability to look at the eye and eyelids under high magnification – a slit lamp examination – gives us an advantage in the diagnosis of ocular rosacea.”
If these patients do have ocular rosacea, their prognosis is unclear. “Unfortunately, many of our treatments haven’t been carefully vetted,” Dr. Wladis said.
He tends to begin with simpler treatments to heal the ocular surface, such as artificial tears and plugs in the tear drainage ducts to keep tears from leaving the eye quickly. Eyelid scrubs and warm compresses can also be helpful, he said, along with suggestions about lifestyle modifications to avoid the triggers that may exacerbate rosacea.
If those treatments fail, antibiotics are an option.
A 2015 Cochrane Review of studies of rosacea treatments suggested that for treating ocular rosacea, cyclosporine 0.05% ophthalmic emulsion “appeared to be more effective than artificial tears” (Cochrane Database Syst Rev. 2015 Apr 28;[3]:CD003262). And a 2015 study of 38 patients with ocular rosacea concluded that topical cyclosporine was significantly more effective in relieving symptoms and in the treatment of eyelid signs, compared with oral doxycycline (Int J Ophthalmol. 2015 Jun 18;8[3]:544-9).
Antibiotics seem to improve the eyelid’s health, “although some studies have documented that the cornea often doesn’t benefit from antibiotics, and patients’ visual acuity may not improve,” Dr. Wladis said.
Ophthalmologists also may prescribe nonsteroidal and steroidal anti-inflammatory drops, Dr. Slonim added, although “the use of topical ophthalmic steroids do carry the risk of secondary glaucoma with increased intraocular pressures.”
There are even more alternatives. “Dietary modification with omega-3 fatty acids appears to benefit the quality of the tear film,” Dr. Wladis said, referring to the results of a prospective, placebo-controlled, double-blind, randomized trial of patients with dry eye (Int J Ophthalmol. 2013 Dec 18;[6]:811-6). “Intraductal meibomian gland probing and intense pulsed light therapy have both been shown to improve ocular surface–related quality of life, although these treatments are relatively invasive and can rapidly become quite expensive for the patient.”
What’s on the horizon? Researchers have “started to unlock the mysteries of rosacea at the cellular level,” Dr. Wladis said. “Our efforts have recently focused on the cellular changes in the skin of rosacea patients. Using several methods, we assayed the activation of a wide variety of signals within the cells of the skin of these patients and found a consistent elevation of two specific signals.”
The researchers were especially pleased, he said, “that these signals appear to be activated in the outer layers of the skin, meaning that a topical preparation could be developed to selectively suppress these cell signals to turn off the disease without interfering with normal skin structure and function and without the side effects of oral or intravenous medications.”
His team is now working on a topical medication. “Ideally,” he noted, “future clinicians will be able to shift their focus from nonspecific therapies like antibiotics and steroids to really powerful, meaningful cellular therapeutics.”
Dr. Slonim reported no relevant disclosures. Dr. Wladis shares a provisional patent for the use of topical kinase inhibitors in the management of rosacea and recently co-started a biotechnology company called Praxis Biotechnology that aims to develop and test therapies for the condition. He serves as a consultant for both Bausch & Lomb and Valeant Pharmaceuticals.
Few skin disorders have the power to devastate lives like ocular rosacea, a painful condition that disrupts vision and can lead to blindness, according to ophthalmologist Edward Wladis, MD.
“Patients really suffer from this diagnosis,” said Dr. Wladis, who practices in Slingerlands, N.Y.
Charles Slonim, MD, an ophthalmologist who practices in Tampa, Fla., put it this way: “We control the condition more than 50 percent of the time, but frequently patients go into periods of remission only to have a recurrence or exacerbation of their ocular rosacea.”
Dr. Wladis coauthored a 2013 report that examined treatments for ocular rosacea, which noted that estimates of the proportion of people with rosacea in the United States who develop ocular rosacea vary, ranging from 58% to 72% (US Ophthalmic Review, 2013;6[2]:86-8).
“Ocular rosacea is one of the subtypes of this disease of cutaneous inflammation,” Dr. Wladis said. “Once the skin becomes so severely inflamed, the glands that lubricate the eye become damaged, and the tear film evaporates rapidly. As a result, patients complain of the effects of a dry ocular surface, and they suffer from blurred vision, tearing, pain, and problems with glare.”
Dr. Slonim suggests that dermatologists refer rosacea patients to an ophthalmologist if they present with any eye symptom, such as dryness, burning, or itching, foreign body sensation in one or both eyes, or chronic redness of either the eyes or the eyelid margins. “They should be seen should be seen by an ophthalmologist to rule out ocular rosacea,” he said. “The ophthalmologist’s ability to look at the eye and eyelids under high magnification – a slit lamp examination – gives us an advantage in the diagnosis of ocular rosacea.”
If these patients do have ocular rosacea, their prognosis is unclear. “Unfortunately, many of our treatments haven’t been carefully vetted,” Dr. Wladis said.
He tends to begin with simpler treatments to heal the ocular surface, such as artificial tears and plugs in the tear drainage ducts to keep tears from leaving the eye quickly. Eyelid scrubs and warm compresses can also be helpful, he said, along with suggestions about lifestyle modifications to avoid the triggers that may exacerbate rosacea.
If those treatments fail, antibiotics are an option.
A 2015 Cochrane Review of studies of rosacea treatments suggested that for treating ocular rosacea, cyclosporine 0.05% ophthalmic emulsion “appeared to be more effective than artificial tears” (Cochrane Database Syst Rev. 2015 Apr 28;[3]:CD003262). And a 2015 study of 38 patients with ocular rosacea concluded that topical cyclosporine was significantly more effective in relieving symptoms and in the treatment of eyelid signs, compared with oral doxycycline (Int J Ophthalmol. 2015 Jun 18;8[3]:544-9).
Antibiotics seem to improve the eyelid’s health, “although some studies have documented that the cornea often doesn’t benefit from antibiotics, and patients’ visual acuity may not improve,” Dr. Wladis said.
Ophthalmologists also may prescribe nonsteroidal and steroidal anti-inflammatory drops, Dr. Slonim added, although “the use of topical ophthalmic steroids do carry the risk of secondary glaucoma with increased intraocular pressures.”
There are even more alternatives. “Dietary modification with omega-3 fatty acids appears to benefit the quality of the tear film,” Dr. Wladis said, referring to the results of a prospective, placebo-controlled, double-blind, randomized trial of patients with dry eye (Int J Ophthalmol. 2013 Dec 18;[6]:811-6). “Intraductal meibomian gland probing and intense pulsed light therapy have both been shown to improve ocular surface–related quality of life, although these treatments are relatively invasive and can rapidly become quite expensive for the patient.”
What’s on the horizon? Researchers have “started to unlock the mysteries of rosacea at the cellular level,” Dr. Wladis said. “Our efforts have recently focused on the cellular changes in the skin of rosacea patients. Using several methods, we assayed the activation of a wide variety of signals within the cells of the skin of these patients and found a consistent elevation of two specific signals.”
The researchers were especially pleased, he said, “that these signals appear to be activated in the outer layers of the skin, meaning that a topical preparation could be developed to selectively suppress these cell signals to turn off the disease without interfering with normal skin structure and function and without the side effects of oral or intravenous medications.”
His team is now working on a topical medication. “Ideally,” he noted, “future clinicians will be able to shift their focus from nonspecific therapies like antibiotics and steroids to really powerful, meaningful cellular therapeutics.”
Dr. Slonim reported no relevant disclosures. Dr. Wladis shares a provisional patent for the use of topical kinase inhibitors in the management of rosacea and recently co-started a biotechnology company called Praxis Biotechnology that aims to develop and test therapies for the condition. He serves as a consultant for both Bausch & Lomb and Valeant Pharmaceuticals.
