DENVER – Among patients with facial erythema associated with erythrotelangiectatic rosacea, combining a long-pulsed 532 nm laser with daily application of a topical skin care regimen achieved equivalent to superior results in fewer treatments, compared with long-pulsed laser treatment alone.

The findings come from a pilot trial that Brian S. Biesman, MD, presented at the annual conference of the American Society for Laser Medicine and Surgery.

“Vascular laser therapy is the standard of care for reduction of facial erythema associated with erythrotelangiectatic rosacea,” said Dr. Biesman, an oculofacial plastic surgeon who practices in Nashville, Tenn. “The question was, if we combine topicals plus laser, can we get an enhanced outcome relative to laser treatment alone?”

To find out, he and his colleagues conducted a blinded, controlled prospective study of 30 subjects with mild to moderate erythrotelangiectatic rosacea who were evenly split into two groups. Those in group 1 received three treatments with the Excel V 532 nm long-pulsed laser by Cutera. Those in group 2 received two laser treatments with the Excel V long-pulsed 532 nm long-pulsed laser plus concurrent daily use of the topical Jan Marini Skin Care Management System, which included a glycolic acid cleanser, vitamin C serum, active containing glycolic, salicylic and azelaic acids, peptide, and growth factor moisturizer and a broad-spectrum sunscreen. It also contained RosaLieve, a proprietary redness-reducing complex.

The researchers performed laser treatments at 4-week intervals and evaluated subjects at baseline, 4, 8, and 12 weeks by physician and subject self-assessment using 5-point (0-4) standardized scales: the Clinician Erythema Assessment (CEA) and patient self-assessment as well as a dermatology Quality of Life Assessment. In both treatment groups, reduction in facial erythema as assessed by CEA and patient self-assessment showed statistically significant improvement at all measured intervals. Specifically, average CEA scores improved from 3.00 to 1.87 among patients in group 1, and from 3.07 to 1.64 among those in group 2. “These were both statistically significant from baseline,” Dr. Biesman said. “What does it really say? The laser plus topical was superior to the laser-only treatment at all measured intervals. I didn’t expect to see that. There was continued improvement noted from week 8 to week 12. That was more of a trend; it was not statistically significant. There were no complications or adverse reactions in either group. The study data indicate that best results may be achieved with a combination of laser and home care.”

He acknowledged certain limitations of the study, including its small sample size and relatively short course of follow-up. “We didn’t have standardization of topical therapy in the laser-only group,” Dr. Biesman said. “Those patients were told to use their usual topical regimen. They were not allowed to use retinoids. We also didn’t have a control arm.”

He disclosed that he has received grant funding from Jan Marini Skin Research and Cutera.

[email protected]

DENVER – Among patients with facial erythema associated with erythrotelangiectatic rosacea, combining a long-pulsed 532 nm laser with daily application of a topical skin care regimen achieved equivalent to superior results in fewer treatments, compared with long-pulsed laser treatment alone.

The findings come from a pilot trial that Brian S. Biesman, MD, presented at the annual conference of the American Society for Laser Medicine and Surgery.

“Vascular laser therapy is the standard of care for reduction of facial erythema associated with erythrotelangiectatic rosacea,” said Dr. Biesman, an oculofacial plastic surgeon who practices in Nashville, Tenn. “The question was, if we combine topicals plus laser, can we get an enhanced outcome relative to laser treatment alone?”

To find out, he and his colleagues conducted a blinded, controlled prospective study of 30 subjects with mild to moderate erythrotelangiectatic rosacea who were evenly split into two groups. Those in group 1 received three treatments with the Excel V 532 nm long-pulsed laser by Cutera. Those in group 2 received two laser treatments with the Excel V long-pulsed 532 nm long-pulsed laser plus concurrent daily use of the topical Jan Marini Skin Care Management System, which included a glycolic acid cleanser, vitamin C serum, active containing glycolic, salicylic and azelaic acids, peptide, and growth factor moisturizer and a broad-spectrum sunscreen. It also contained RosaLieve, a proprietary redness-reducing complex.

The researchers performed laser treatments at 4-week intervals and evaluated subjects at baseline, 4, 8, and 12 weeks by physician and subject self-assessment using 5-point (0-4) standardized scales: the Clinician Erythema Assessment (CEA) and patient self-assessment as well as a dermatology Quality of Life Assessment. In both treatment groups, reduction in facial erythema as assessed by CEA and patient self-assessment showed statistically significant improvement at all measured intervals. Specifically, average CEA scores improved from 3.00 to 1.87 among patients in group 1, and from 3.07 to 1.64 among those in group 2. “These were both statistically significant from baseline,” Dr. Biesman said. “What does it really say? The laser plus topical was superior to the laser-only treatment at all measured intervals. I didn’t expect to see that. There was continued improvement noted from week 8 to week 12. That was more of a trend; it was not statistically significant. There were no complications or adverse reactions in either group. The study data indicate that best results may be achieved with a combination of laser and home care.”

He acknowledged certain limitations of the study, including its small sample size and relatively short course of follow-up. “We didn’t have standardization of topical therapy in the laser-only group,” Dr. Biesman said. “Those patients were told to use their usual topical regimen. They were not allowed to use retinoids. We also didn’t have a control arm.”

He disclosed that he has received grant funding from Jan Marini Skin Research and Cutera.

[email protected]

DENVER – Among patients with facial erythema associated with erythrotelangiectatic rosacea, combining a long-pulsed 532 nm laser with daily application of a topical skin care regimen achieved equivalent to superior results in fewer treatments, compared with long-pulsed laser treatment alone.

The findings come from a pilot trial that Brian S. Biesman, MD, presented at the annual conference of the American Society for Laser Medicine and Surgery.

“Vascular laser therapy is the standard of care for reduction of facial erythema associated with erythrotelangiectatic rosacea,” said Dr. Biesman, an oculofacial plastic surgeon who practices in Nashville, Tenn. “The question was, if we combine topicals plus laser, can we get an enhanced outcome relative to laser treatment alone?”

To find out, he and his colleagues conducted a blinded, controlled prospective study of 30 subjects with mild to moderate erythrotelangiectatic rosacea who were evenly split into two groups. Those in group 1 received three treatments with the Excel V 532 nm long-pulsed laser by Cutera. Those in group 2 received two laser treatments with the Excel V long-pulsed 532 nm long-pulsed laser plus concurrent daily use of the topical Jan Marini Skin Care Management System, which included a glycolic acid cleanser, vitamin C serum, active containing glycolic, salicylic and azelaic acids, peptide, and growth factor moisturizer and a broad-spectrum sunscreen. It also contained RosaLieve, a proprietary redness-reducing complex.

The researchers performed laser treatments at 4-week intervals and evaluated subjects at baseline, 4, 8, and 12 weeks by physician and subject self-assessment using 5-point (0-4) standardized scales: the Clinician Erythema Assessment (CEA) and patient self-assessment as well as a dermatology Quality of Life Assessment. In both treatment groups, reduction in facial erythema as assessed by CEA and patient self-assessment showed statistically significant improvement at all measured intervals. Specifically, average CEA scores improved from 3.00 to 1.87 among patients in group 1, and from 3.07 to 1.64 among those in group 2. “These were both statistically significant from baseline,” Dr. Biesman said. “What does it really say? The laser plus topical was superior to the laser-only treatment at all measured intervals. I didn’t expect to see that. There was continued improvement noted from week 8 to week 12. That was more of a trend; it was not statistically significant. There were no complications or adverse reactions in either group. The study data indicate that best results may be achieved with a combination of laser and home care.”

He acknowledged certain limitations of the study, including its small sample size and relatively short course of follow-up. “We didn’t have standardization of topical therapy in the laser-only group,” Dr. Biesman said. “Those patients were told to use their usual topical regimen. They were not allowed to use retinoids. We also didn’t have a control arm.”

He disclosed that he has received grant funding from Jan Marini Skin Research and Cutera.

[email protected]

DENVER – A device that provides electromagnetic stimulation to muscles is being investigated as a way to complement noninvasive body contouring.

The device, known as CoolTone, is being developed by Allergan and uses high-powered coil electromagnetic stimulation applicators to induce eddy currents in the muscle tissue. CoolTone is pending Food and Drug Administration clearance and is not yet commercially available.

“Fat reduction is just one part of body contouring,” Mathew M. Avram, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “You have skin, fat, and muscle. More and more we’re targeting all three areas for patients’ best body contouring outcomes.”

According to Dr. Avram, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston, CoolTone provides high-frequency electromagnetic muscle stimulation that triggers muscle contractions that cannot be achieved by normal exercise to increase muscle mass and strength. “You’re doing super physiological amounts of contractions with this stimulation – the equivalent of doing thousands of sit-ups, if you’re treating the abdomen,” he said. “It strengthens, tones, and firms muscles in abdomen, buttocks, arms, and legs. There is a history of this type of technology for athletes and other indications in physical therapy.”

The current FDA clearance for a predicate electromagnetic stimulation system for muscle conditioning is for the abdomen, buttocks, thighs, and arms. “This is for improvement of abdominal tone, strengthening of the abdominal muscles, and development of a firmer abdomen,” said Dr. Avram, who also is director of dermatologic surgery at Mass General. “It’s for strengthening, toning, and firming of buttocks and thighs, and for improvement of muscle tone and firmness, and for strengthening muscle in arms.”

The electrical current induced by the CoolTone device flows readily into muscle and not into fat, he continued. This brings the current to nearby motor nerve structures that stimulate contraction once the action potential is reached. “You’re getting maximal contractions that are extreme for a full range of muscle fibers,” explained Dr. Avram, who is the immediate past president of the ASLMS. “This requires an external electrical stimulus; it’s not something you do with normal exercise. With mild exercise, only the slow-twitch muscle fibers are activated, not the fast-twitch muscle fibers. Also, the pulsing sequences are designed to preferentially excite motor nerves rather than sensory nerves. So it’s really going after the ability for you to contract your muscles as much as possible.”

Dr. Avram has received consulting fees from Merz and Alastin and holds ownership interests with ZALEA, InMode, and Cytrellis. He has served on the advisory boards for ZELTIQ Aesthetics, Soliton, Sciton, and Sienna Biopharmaceuticals, and he has intellectual property rights with Cytrellis.

[email protected]

DENVER – A device that provides electromagnetic stimulation to muscles is being investigated as a way to complement noninvasive body contouring.

The device, known as CoolTone, is being developed by Allergan and uses high-powered coil electromagnetic stimulation applicators to induce eddy currents in the muscle tissue. CoolTone is pending Food and Drug Administration clearance and is not yet commercially available.

“Fat reduction is just one part of body contouring,” Mathew M. Avram, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “You have skin, fat, and muscle. More and more we’re targeting all three areas for patients’ best body contouring outcomes.”

According to Dr. Avram, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston, CoolTone provides high-frequency electromagnetic muscle stimulation that triggers muscle contractions that cannot be achieved by normal exercise to increase muscle mass and strength. “You’re doing super physiological amounts of contractions with this stimulation – the equivalent of doing thousands of sit-ups, if you’re treating the abdomen,” he said. “It strengthens, tones, and firms muscles in abdomen, buttocks, arms, and legs. There is a history of this type of technology for athletes and other indications in physical therapy.”

The current FDA clearance for a predicate electromagnetic stimulation system for muscle conditioning is for the abdomen, buttocks, thighs, and arms. “This is for improvement of abdominal tone, strengthening of the abdominal muscles, and development of a firmer abdomen,” said Dr. Avram, who also is director of dermatologic surgery at Mass General. “It’s for strengthening, toning, and firming of buttocks and thighs, and for improvement of muscle tone and firmness, and for strengthening muscle in arms.”

The electrical current induced by the CoolTone device flows readily into muscle and not into fat, he continued. This brings the current to nearby motor nerve structures that stimulate contraction once the action potential is reached. “You’re getting maximal contractions that are extreme for a full range of muscle fibers,” explained Dr. Avram, who is the immediate past president of the ASLMS. “This requires an external electrical stimulus; it’s not something you do with normal exercise. With mild exercise, only the slow-twitch muscle fibers are activated, not the fast-twitch muscle fibers. Also, the pulsing sequences are designed to preferentially excite motor nerves rather than sensory nerves. So it’s really going after the ability for you to contract your muscles as much as possible.”

Dr. Avram has received consulting fees from Merz and Alastin and holds ownership interests with ZALEA, InMode, and Cytrellis. He has served on the advisory boards for ZELTIQ Aesthetics, Soliton, Sciton, and Sienna Biopharmaceuticals, and he has intellectual property rights with Cytrellis.

[email protected]

DENVER – A device that provides electromagnetic stimulation to muscles is being investigated as a way to complement noninvasive body contouring.

The device, known as CoolTone, is being developed by Allergan and uses high-powered coil electromagnetic stimulation applicators to induce eddy currents in the muscle tissue. CoolTone is pending Food and Drug Administration clearance and is not yet commercially available.

“Fat reduction is just one part of body contouring,” Mathew M. Avram, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “You have skin, fat, and muscle. More and more we’re targeting all three areas for patients’ best body contouring outcomes.”

According to Dr. Avram, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston, CoolTone provides high-frequency electromagnetic muscle stimulation that triggers muscle contractions that cannot be achieved by normal exercise to increase muscle mass and strength. “You’re doing super physiological amounts of contractions with this stimulation – the equivalent of doing thousands of sit-ups, if you’re treating the abdomen,” he said. “It strengthens, tones, and firms muscles in abdomen, buttocks, arms, and legs. There is a history of this type of technology for athletes and other indications in physical therapy.”

The current FDA clearance for a predicate electromagnetic stimulation system for muscle conditioning is for the abdomen, buttocks, thighs, and arms. “This is for improvement of abdominal tone, strengthening of the abdominal muscles, and development of a firmer abdomen,” said Dr. Avram, who also is director of dermatologic surgery at Mass General. “It’s for strengthening, toning, and firming of buttocks and thighs, and for improvement of muscle tone and firmness, and for strengthening muscle in arms.”

The electrical current induced by the CoolTone device flows readily into muscle and not into fat, he continued. This brings the current to nearby motor nerve structures that stimulate contraction once the action potential is reached. “You’re getting maximal contractions that are extreme for a full range of muscle fibers,” explained Dr. Avram, who is the immediate past president of the ASLMS. “This requires an external electrical stimulus; it’s not something you do with normal exercise. With mild exercise, only the slow-twitch muscle fibers are activated, not the fast-twitch muscle fibers. Also, the pulsing sequences are designed to preferentially excite motor nerves rather than sensory nerves. So it’s really going after the ability for you to contract your muscles as much as possible.”

Dr. Avram has received consulting fees from Merz and Alastin and holds ownership interests with ZALEA, InMode, and Cytrellis. He has served on the advisory boards for ZELTIQ Aesthetics, Soliton, Sciton, and Sienna Biopharmaceuticals, and he has intellectual property rights with Cytrellis.

[email protected]

High plasma levels of tumor necrosis factor (TNF)–alpha and adiponectin can be used to differentiate patients with psoriasis and psoriatic arthritis, according to Wen-Qing Li, PhD, of Brown University, Providence, R.I., and his associates.

In a research letter published in the British Journal of Dermatology, the investigators detailed an analysis of 180 patients with psoriasis only and 143 patients with psoriatic arthritis (PsA) from the Psoriatic Arthritis and Psoriasis Follow-up Study. Patients in both groups had a mean age of 51 years. Plasma levels of interleukin-6, C-reactive protein, TNF-alpha, leptin, total adiponectin, and high-molecular-weight (HMW) adiponectin were assessed as potential biomarkers by ultrasensitive enzyme-linked immunosorbent assay or immunoturbidimetric assay.

Median TNF-alpha plasma levels were higher in patients with PsA, compared with those with psoriasis (3.27 vs. 1.32 pg/mL^–1), while total and HMW adiponectin levels were lower in patients with PsA, compared with those with psoriasis (4.66 vs. 5.36 mcg/mL^–1; 2.58 vs. 3.01 mcg/mL^–1). After logistic regression, TNF-alpha (adjusted odds ratio, 2.25; 95% confidence interval, 1.41-3.61) and total adiponectin (aOR, 0.61; 95% CI, 0.39-0.96) remained significantly associated as biomarkers. HMW adiponectin maintained marginal significance (aOR, 0.64; 95% CI, 0.41-1.01).

“Further large-scale investigation in a prospective setting of patients with PsO [psoriasis] would be warranted, if a clinically useful screening test is to be developed for risk prediction of PsA based on circulating biomarkers,” the investigators concluded.

Two study authors reported consulting with or advising numerous pharmaceutical companies.

[email protected]

SOURCE: Li W-Q et al. Br J Dermatol. 2019 Jan 29. doi: 10.1111/bjd.17700.

High plasma levels of tumor necrosis factor (TNF)–alpha and adiponectin can be used to differentiate patients with psoriasis and psoriatic arthritis, according to Wen-Qing Li, PhD, of Brown University, Providence, R.I., and his associates.

In a research letter published in the British Journal of Dermatology, the investigators detailed an analysis of 180 patients with psoriasis only and 143 patients with psoriatic arthritis (PsA) from the Psoriatic Arthritis and Psoriasis Follow-up Study. Patients in both groups had a mean age of 51 years. Plasma levels of interleukin-6, C-reactive protein, TNF-alpha, leptin, total adiponectin, and high-molecular-weight (HMW) adiponectin were assessed as potential biomarkers by ultrasensitive enzyme-linked immunosorbent assay or immunoturbidimetric assay.

Median TNF-alpha plasma levels were higher in patients with PsA, compared with those with psoriasis (3.27 vs. 1.32 pg/mL^–1), while total and HMW adiponectin levels were lower in patients with PsA, compared with those with psoriasis (4.66 vs. 5.36 mcg/mL^–1; 2.58 vs. 3.01 mcg/mL^–1). After logistic regression, TNF-alpha (adjusted odds ratio, 2.25; 95% confidence interval, 1.41-3.61) and total adiponectin (aOR, 0.61; 95% CI, 0.39-0.96) remained significantly associated as biomarkers. HMW adiponectin maintained marginal significance (aOR, 0.64; 95% CI, 0.41-1.01).

“Further large-scale investigation in a prospective setting of patients with PsO [psoriasis] would be warranted, if a clinically useful screening test is to be developed for risk prediction of PsA based on circulating biomarkers,” the investigators concluded.

Two study authors reported consulting with or advising numerous pharmaceutical companies.

[email protected]

SOURCE: Li W-Q et al. Br J Dermatol. 2019 Jan 29. doi: 10.1111/bjd.17700.

High plasma levels of tumor necrosis factor (TNF)–alpha and adiponectin can be used to differentiate patients with psoriasis and psoriatic arthritis, according to Wen-Qing Li, PhD, of Brown University, Providence, R.I., and his associates.

In a research letter published in the British Journal of Dermatology, the investigators detailed an analysis of 180 patients with psoriasis only and 143 patients with psoriatic arthritis (PsA) from the Psoriatic Arthritis and Psoriasis Follow-up Study. Patients in both groups had a mean age of 51 years. Plasma levels of interleukin-6, C-reactive protein, TNF-alpha, leptin, total adiponectin, and high-molecular-weight (HMW) adiponectin were assessed as potential biomarkers by ultrasensitive enzyme-linked immunosorbent assay or immunoturbidimetric assay.

Median TNF-alpha plasma levels were higher in patients with PsA, compared with those with psoriasis (3.27 vs. 1.32 pg/mL^–1), while total and HMW adiponectin levels were lower in patients with PsA, compared with those with psoriasis (4.66 vs. 5.36 mcg/mL^–1; 2.58 vs. 3.01 mcg/mL^–1). After logistic regression, TNF-alpha (adjusted odds ratio, 2.25; 95% confidence interval, 1.41-3.61) and total adiponectin (aOR, 0.61; 95% CI, 0.39-0.96) remained significantly associated as biomarkers. HMW adiponectin maintained marginal significance (aOR, 0.64; 95% CI, 0.41-1.01).

“Further large-scale investigation in a prospective setting of patients with PsO [psoriasis] would be warranted, if a clinically useful screening test is to be developed for risk prediction of PsA based on circulating biomarkers,” the investigators concluded.

Two study authors reported consulting with or advising numerous pharmaceutical companies.

[email protected]

SOURCE: Li W-Q et al. Br J Dermatol. 2019 Jan 29. doi: 10.1111/bjd.17700.

PHILADELPHIA – Medical marijuana research to date provides some support for its use in neuropathic pain, nausea and vomiting, and spasticity, some insights into adverse effects, and “a lot of the Wild West,” Ellie Grossman, MD, MPH, said here at the annual meeting of the American College of Physicians.

Andrew Bowser/MDedge News

The opioid-sparing effects of medical marijuana have been highlighted in recent reports suggesting that cannabis users may use less opioids, and that states with medical marijuana laws have seen drops in opioid overdose mortality, Dr. Grossman said.

“That’s kind of a story on pain and cannabinoids, and that’s really the biggest story there is in terms of medical evidence and effectiveness for this agent,” said Dr. Grossman, an instructor at Harvard Medical School and Primary Care Lead for Behavioral Health Integration, Cambridge Health Alliance, Somerville, Mass.

However, being the top story in medical marijuana may not be a very high bar in 2019, given current issues with research in this area, including inconsistencies in medical marijuana formulations, relatively small numbers of patients enrolled in studies, and meta-analyses that have produced equivocal results.

“Unfortunately, this is an area where there’s a lot of, shall I say, ‘squishiness’ in the data, through no fault of the researchers involved – it’s just an area that’s really hard to study,” Dr. Goodman said in her update on medical marijuana use at the meeting.

Most studies of cannabinoids for chronic pain have compared these agents to placebo, rather than the long list of other medications that might be used to treat pain, Dr. Grossman said.

There are several meta-analyses available, including a recently published Cochrane review in which authors concluded that, for neuropathic pain, the potential benefits of cannabis-based medicines may outweigh their potential harms.

“The upshot here is that there may be some evidence for neuropathic pain, but the evidence is generally of poor quality and kind of mixed,” said Dr. Grossman.

State-level medical cannabis laws were linked to significantly lower opioid overdose mortality rates in a 2014 study (JAMA Intern Med. 2014;174[10]:1668-73). In more recent studies, states with medical cannabis laws were found to have lower Medicare Part D opioid-prescribing rates, and in another study, legalization of medical marijuana was linked to lower rates of chronic and high-risk opioid use.

“It certainly seems like maybe we as prescribers are prescribing [fewer] opioids if there’s medical cannabis around,” Dr. Grossman said. “What this means for our patients in the short term and long term, we don’t totally know. But clearly, fewer opioid overdoses is a way better thing than more, so there could be something here.”

The cannabinoids approved by the Food and Drug Administration include nabilone (Cesamet) and dronabinol (Marinol), both synthetic cannabinoids indicated for cancer chemotherapy–related nausea and vomiting, along with cannabidiol (Epidiolex), just approved in June 2018 for treatment of some rare pediatric refractory epilepsy syndromes, Dr. Grossman said.

For chemotherapy-induced nausea and vomiting, evidence suggests oral cannabinoids are more effective than placebo, but there’s mixed evidence as to whether they are better than other antiemetics, Dr. Grossman said, while in terms of spasticity related to multiple sclerosis, research has shown small improvements in patient-reported symptoms.

Long-term adverse event data specific to medical marijuana are scant, with much of the evidence coming from studies of recreational marijuana users, Dr. Grossman said.

Those long-term effects include increased risk of pulmonary effects such as cough, wheeze, and phlegm that improve with discontinuation; case reports of unintentional pediatric ingestions; and lower neonatal birth weight, which should be discussed with women of reproductive age who are using or considering medical marijuana, Dr. Grossman said.

Motor vehicle accidents, development of psychiatric symptoms, and psychosis relapse also have been linked to use, she said.

Some real-world adverse event data specific to medical marijuana data are available through the Minnesota medical cannabis program. They found 16% of surveyed users reported an adverse event within the first 4 months, including dry mouth, fatigue, mental clouding, and drowsiness, Dr. Grossman told attendees.

Dr. Grossman reported that she has no relationship with entities producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

SOURCE: Grossman E. ACP 2019, Presentation MTP 010.

PHILADELPHIA – Medical marijuana research to date provides some support for its use in neuropathic pain, nausea and vomiting, and spasticity, some insights into adverse effects, and “a lot of the Wild West,” Ellie Grossman, MD, MPH, said here at the annual meeting of the American College of Physicians.

Andrew Bowser/MDedge News

The opioid-sparing effects of medical marijuana have been highlighted in recent reports suggesting that cannabis users may use less opioids, and that states with medical marijuana laws have seen drops in opioid overdose mortality, Dr. Grossman said.

“That’s kind of a story on pain and cannabinoids, and that’s really the biggest story there is in terms of medical evidence and effectiveness for this agent,” said Dr. Grossman, an instructor at Harvard Medical School and Primary Care Lead for Behavioral Health Integration, Cambridge Health Alliance, Somerville, Mass.

However, being the top story in medical marijuana may not be a very high bar in 2019, given current issues with research in this area, including inconsistencies in medical marijuana formulations, relatively small numbers of patients enrolled in studies, and meta-analyses that have produced equivocal results.

“Unfortunately, this is an area where there’s a lot of, shall I say, ‘squishiness’ in the data, through no fault of the researchers involved – it’s just an area that’s really hard to study,” Dr. Goodman said in her update on medical marijuana use at the meeting.

Most studies of cannabinoids for chronic pain have compared these agents to placebo, rather than the long list of other medications that might be used to treat pain, Dr. Grossman said.

There are several meta-analyses available, including a recently published Cochrane review in which authors concluded that, for neuropathic pain, the potential benefits of cannabis-based medicines may outweigh their potential harms.

“The upshot here is that there may be some evidence for neuropathic pain, but the evidence is generally of poor quality and kind of mixed,” said Dr. Grossman.

State-level medical cannabis laws were linked to significantly lower opioid overdose mortality rates in a 2014 study (JAMA Intern Med. 2014;174[10]:1668-73). In more recent studies, states with medical cannabis laws were found to have lower Medicare Part D opioid-prescribing rates, and in another study, legalization of medical marijuana was linked to lower rates of chronic and high-risk opioid use.

“It certainly seems like maybe we as prescribers are prescribing [fewer] opioids if there’s medical cannabis around,” Dr. Grossman said. “What this means for our patients in the short term and long term, we don’t totally know. But clearly, fewer opioid overdoses is a way better thing than more, so there could be something here.”

The cannabinoids approved by the Food and Drug Administration include nabilone (Cesamet) and dronabinol (Marinol), both synthetic cannabinoids indicated for cancer chemotherapy–related nausea and vomiting, along with cannabidiol (Epidiolex), just approved in June 2018 for treatment of some rare pediatric refractory epilepsy syndromes, Dr. Grossman said.

For chemotherapy-induced nausea and vomiting, evidence suggests oral cannabinoids are more effective than placebo, but there’s mixed evidence as to whether they are better than other antiemetics, Dr. Grossman said, while in terms of spasticity related to multiple sclerosis, research has shown small improvements in patient-reported symptoms.

Long-term adverse event data specific to medical marijuana are scant, with much of the evidence coming from studies of recreational marijuana users, Dr. Grossman said.

Those long-term effects include increased risk of pulmonary effects such as cough, wheeze, and phlegm that improve with discontinuation; case reports of unintentional pediatric ingestions; and lower neonatal birth weight, which should be discussed with women of reproductive age who are using or considering medical marijuana, Dr. Grossman said.

Motor vehicle accidents, development of psychiatric symptoms, and psychosis relapse also have been linked to use, she said.

Some real-world adverse event data specific to medical marijuana data are available through the Minnesota medical cannabis program. They found 16% of surveyed users reported an adverse event within the first 4 months, including dry mouth, fatigue, mental clouding, and drowsiness, Dr. Grossman told attendees.

Dr. Grossman reported that she has no relationship with entities producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

SOURCE: Grossman E. ACP 2019, Presentation MTP 010.

PHILADELPHIA – Medical marijuana research to date provides some support for its use in neuropathic pain, nausea and vomiting, and spasticity, some insights into adverse effects, and “a lot of the Wild West,” Ellie Grossman, MD, MPH, said here at the annual meeting of the American College of Physicians.

Andrew Bowser/MDedge News

The opioid-sparing effects of medical marijuana have been highlighted in recent reports suggesting that cannabis users may use less opioids, and that states with medical marijuana laws have seen drops in opioid overdose mortality, Dr. Grossman said.

“That’s kind of a story on pain and cannabinoids, and that’s really the biggest story there is in terms of medical evidence and effectiveness for this agent,” said Dr. Grossman, an instructor at Harvard Medical School and Primary Care Lead for Behavioral Health Integration, Cambridge Health Alliance, Somerville, Mass.

However, being the top story in medical marijuana may not be a very high bar in 2019, given current issues with research in this area, including inconsistencies in medical marijuana formulations, relatively small numbers of patients enrolled in studies, and meta-analyses that have produced equivocal results.

“Unfortunately, this is an area where there’s a lot of, shall I say, ‘squishiness’ in the data, through no fault of the researchers involved – it’s just an area that’s really hard to study,” Dr. Goodman said in her update on medical marijuana use at the meeting.

Most studies of cannabinoids for chronic pain have compared these agents to placebo, rather than the long list of other medications that might be used to treat pain, Dr. Grossman said.

There are several meta-analyses available, including a recently published Cochrane review in which authors concluded that, for neuropathic pain, the potential benefits of cannabis-based medicines may outweigh their potential harms.

“The upshot here is that there may be some evidence for neuropathic pain, but the evidence is generally of poor quality and kind of mixed,” said Dr. Grossman.

State-level medical cannabis laws were linked to significantly lower opioid overdose mortality rates in a 2014 study (JAMA Intern Med. 2014;174[10]:1668-73). In more recent studies, states with medical cannabis laws were found to have lower Medicare Part D opioid-prescribing rates, and in another study, legalization of medical marijuana was linked to lower rates of chronic and high-risk opioid use.

“It certainly seems like maybe we as prescribers are prescribing [fewer] opioids if there’s medical cannabis around,” Dr. Grossman said. “What this means for our patients in the short term and long term, we don’t totally know. But clearly, fewer opioid overdoses is a way better thing than more, so there could be something here.”

The cannabinoids approved by the Food and Drug Administration include nabilone (Cesamet) and dronabinol (Marinol), both synthetic cannabinoids indicated for cancer chemotherapy–related nausea and vomiting, along with cannabidiol (Epidiolex), just approved in June 2018 for treatment of some rare pediatric refractory epilepsy syndromes, Dr. Grossman said.

For chemotherapy-induced nausea and vomiting, evidence suggests oral cannabinoids are more effective than placebo, but there’s mixed evidence as to whether they are better than other antiemetics, Dr. Grossman said, while in terms of spasticity related to multiple sclerosis, research has shown small improvements in patient-reported symptoms.

Long-term adverse event data specific to medical marijuana are scant, with much of the evidence coming from studies of recreational marijuana users, Dr. Grossman said.

Those long-term effects include increased risk of pulmonary effects such as cough, wheeze, and phlegm that improve with discontinuation; case reports of unintentional pediatric ingestions; and lower neonatal birth weight, which should be discussed with women of reproductive age who are using or considering medical marijuana, Dr. Grossman said.

Motor vehicle accidents, development of psychiatric symptoms, and psychosis relapse also have been linked to use, she said.

Some real-world adverse event data specific to medical marijuana data are available through the Minnesota medical cannabis program. They found 16% of surveyed users reported an adverse event within the first 4 months, including dry mouth, fatigue, mental clouding, and drowsiness, Dr. Grossman told attendees.

Dr. Grossman reported that she has no relationship with entities producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

SOURCE: Grossman E. ACP 2019, Presentation MTP 010.

NEW ORLEANS – Waiting a few months after a patient has been hospitalized for acute decompensated heart failure before launching a switch from enalapril to sacubitril/valsartan imposes a steep price in terms of extra major cardiovascular events, compared with starting the angiotensin-neprilysin inhibitor during the initial hospitalization, according to the open-label extension of the PIONEER-HF trial.

Bruce Jancin/MDedge News

“We think these data have important clinical implications: While sacubitril/valsartan decreases NT-proBNP compared with enalapril regardless of when it is initiated, the early improvement in postdischarge outcomes supports the in-hospital initiation of sacubitril/valsartan in stabilized patients with acute decompensated heart failure,” Adam D. DeVore, MD, declared in presenting the PIONEER-HF Extension results at the annual meeting of the American College of Cardiology.

PIONEER-HF was a landmark, practice-changing, double-blind clinical trial in which 881 patients were randomized to initiation of sacubitril/valsartan (Entresto) or enalapril during hospitalization for acute decompensated heart failure. In the previously reported main outcome, 8 weeks after discharge the sacubitril/valsartan group had a 29% greater reduction in NT-proBNP (the N-terminal prohormone of brain natriuretic peptide) and a 42% lower rate of the composite clinical endpoint of cardiovascular death or heart failure rehospitalization than the enalapril group (N Engl J Med. 2019 Feb 7;380[6]:539-48).

The 4-week open-label extension of PIONEER-HF began at week 8, when participants initially randomized to enalapril during the double-blind phase were switched to sacubitril/valsartan, while those assigned to in-hospital initiation of the angiotensin-neprilysin inhibitor (ARNI) stayed the course.

At week 12, after 4 weeks of open-label treatment, patients on sacubitril/valsartan from the start experienced an additional 18.5% drop in NT-proBNP from their week-8 baseline of 1,218 pg/mL. Meanwhile, the NT-proBNP level in the switch group plunged by 35.8% from a week-8 baseline of 1,630 pg/mL. As a result, both groups ended up at the same much-improved biomarker level at week 12, observed Dr. DeVore, a cardiologist at Duke University in Durham, N.C.

Clinical event rates, however, were another story altogether. The clinical event gap between the two study arms documented at week 8 in the double-blind phase of the trial didn’t close significantly in the 4 weeks after the enalapril group crossed over to open-label sacubitril/valsartan. Indeed, the relative risk of the composite endpoint of cardiovascular death, heart failure rehospitalization, or left ventricular assist device implantation during the 4-week extension phase was 33% lower in the continuous sacubitril/valsartan group than in the switchers. The absolute risk reduction was 5.6%, with a favorable number needed to treat of 18.

This difference was driven mainly by less rehospitalization for heart failure. Few cardiovascular deaths or LVAD implantations occurred during the relatively brief 4-week extension phase of the trial.

“But this is an important thing as we think about what we’re trying to accomplish in heart failure: trying to find tools that improve rehospitalization rates after people leave the hospital is extremely important,” Dr. DeVore said. “We do know that the really vulnerable period for rehospitalization is early on, so my sus```picion – though I can’t prove it – is that’s the important part. That’s when we need to have patients on the best therapy.”

He was asked how practical it is to initiate sacubitril/valsartan during hospitalization for acute decompensated heart failure in real-world clinical practice, given that it can be done only after patients achieve hemodynamic stability.

“I think the definition of hemodynamic stability we used in the trial was a fairly straightforward one, very clinical, and one we can translate to the bedside,” Dr. DeVore replied. “Patients had to have a systolic blood pressure of 100 mm Hg or greater for 6 hours, which is easily documented in the hospital, no changes in IV diuretics or IV vasodilators for 6 hours, and no IV inotropes for the last 24 hours. That’s how we defined hemodynamic stability. I think we should be able to find these patients.”

Average length of stay in the index hospitalization in PIONEER-HF was just over 5 days, but the study protocol actually resulted in longer-than-needed hospitalization because it required that patients had to receive three double-blind doses of their study medication before discharge. In routine practice, it’s unlikely that in-hospital initiation of sacubitril/valsartan will result in a length of stay greater than the national average of about 4.5 days, according the cardiologist.

Current ACC/American Heart Association/Heart Failure Society of American guidelines on management of heart failure include a Class Ia recommendation to switch patients from an ACE inhibitor or angiotensin inhibitor to sacubitril/valsartan (Circulation. 2017 Aug 8;136[6]:e137-61).

However, heart failure specialists are concerned by national data showing that sacubitril/valsartan remains widely underprescribed.

Dr. DeVore reported serving as a consultant to Novartis and receiving research grants from a half dozen pharmaceutical companies as well as the American Heart Association, National Heart, Lung, and Blood Institute, and the Patient-Centered Outcomes Research Institute .

[email protected]

NEW ORLEANS – Waiting a few months after a patient has been hospitalized for acute decompensated heart failure before launching a switch from enalapril to sacubitril/valsartan imposes a steep price in terms of extra major cardiovascular events, compared with starting the angiotensin-neprilysin inhibitor during the initial hospitalization, according to the open-label extension of the PIONEER-HF trial.

Bruce Jancin/MDedge News

“We think these data have important clinical implications: While sacubitril/valsartan decreases NT-proBNP compared with enalapril regardless of when it is initiated, the early improvement in postdischarge outcomes supports the in-hospital initiation of sacubitril/valsartan in stabilized patients with acute decompensated heart failure,” Adam D. DeVore, MD, declared in presenting the PIONEER-HF Extension results at the annual meeting of the American College of Cardiology.

PIONEER-HF was a landmark, practice-changing, double-blind clinical trial in which 881 patients were randomized to initiation of sacubitril/valsartan (Entresto) or enalapril during hospitalization for acute decompensated heart failure. In the previously reported main outcome, 8 weeks after discharge the sacubitril/valsartan group had a 29% greater reduction in NT-proBNP (the N-terminal prohormone of brain natriuretic peptide) and a 42% lower rate of the composite clinical endpoint of cardiovascular death or heart failure rehospitalization than the enalapril group (N Engl J Med. 2019 Feb 7;380[6]:539-48).

The 4-week open-label extension of PIONEER-HF began at week 8, when participants initially randomized to enalapril during the double-blind phase were switched to sacubitril/valsartan, while those assigned to in-hospital initiation of the angiotensin-neprilysin inhibitor (ARNI) stayed the course.

At week 12, after 4 weeks of open-label treatment, patients on sacubitril/valsartan from the start experienced an additional 18.5% drop in NT-proBNP from their week-8 baseline of 1,218 pg/mL. Meanwhile, the NT-proBNP level in the switch group plunged by 35.8% from a week-8 baseline of 1,630 pg/mL. As a result, both groups ended up at the same much-improved biomarker level at week 12, observed Dr. DeVore, a cardiologist at Duke University in Durham, N.C.

Clinical event rates, however, were another story altogether. The clinical event gap between the two study arms documented at week 8 in the double-blind phase of the trial didn’t close significantly in the 4 weeks after the enalapril group crossed over to open-label sacubitril/valsartan. Indeed, the relative risk of the composite endpoint of cardiovascular death, heart failure rehospitalization, or left ventricular assist device implantation during the 4-week extension phase was 33% lower in the continuous sacubitril/valsartan group than in the switchers. The absolute risk reduction was 5.6%, with a favorable number needed to treat of 18.

This difference was driven mainly by less rehospitalization for heart failure. Few cardiovascular deaths or LVAD implantations occurred during the relatively brief 4-week extension phase of the trial.

“But this is an important thing as we think about what we’re trying to accomplish in heart failure: trying to find tools that improve rehospitalization rates after people leave the hospital is extremely important,” Dr. DeVore said. “We do know that the really vulnerable period for rehospitalization is early on, so my sus```picion – though I can’t prove it – is that’s the important part. That’s when we need to have patients on the best therapy.”

He was asked how practical it is to initiate sacubitril/valsartan during hospitalization for acute decompensated heart failure in real-world clinical practice, given that it can be done only after patients achieve hemodynamic stability.

“I think the definition of hemodynamic stability we used in the trial was a fairly straightforward one, very clinical, and one we can translate to the bedside,” Dr. DeVore replied. “Patients had to have a systolic blood pressure of 100 mm Hg or greater for 6 hours, which is easily documented in the hospital, no changes in IV diuretics or IV vasodilators for 6 hours, and no IV inotropes for the last 24 hours. That’s how we defined hemodynamic stability. I think we should be able to find these patients.”

Average length of stay in the index hospitalization in PIONEER-HF was just over 5 days, but the study protocol actually resulted in longer-than-needed hospitalization because it required that patients had to receive three double-blind doses of their study medication before discharge. In routine practice, it’s unlikely that in-hospital initiation of sacubitril/valsartan will result in a length of stay greater than the national average of about 4.5 days, according the cardiologist.

Current ACC/American Heart Association/Heart Failure Society of American guidelines on management of heart failure include a Class Ia recommendation to switch patients from an ACE inhibitor or angiotensin inhibitor to sacubitril/valsartan (Circulation. 2017 Aug 8;136[6]:e137-61).

However, heart failure specialists are concerned by national data showing that sacubitril/valsartan remains widely underprescribed.

Dr. DeVore reported serving as a consultant to Novartis and receiving research grants from a half dozen pharmaceutical companies as well as the American Heart Association, National Heart, Lung, and Blood Institute, and the Patient-Centered Outcomes Research Institute .

[email protected]

NEW ORLEANS – Waiting a few months after a patient has been hospitalized for acute decompensated heart failure before launching a switch from enalapril to sacubitril/valsartan imposes a steep price in terms of extra major cardiovascular events, compared with starting the angiotensin-neprilysin inhibitor during the initial hospitalization, according to the open-label extension of the PIONEER-HF trial.

Bruce Jancin/MDedge News

“We think these data have important clinical implications: While sacubitril/valsartan decreases NT-proBNP compared with enalapril regardless of when it is initiated, the early improvement in postdischarge outcomes supports the in-hospital initiation of sacubitril/valsartan in stabilized patients with acute decompensated heart failure,” Adam D. DeVore, MD, declared in presenting the PIONEER-HF Extension results at the annual meeting of the American College of Cardiology.

PIONEER-HF was a landmark, practice-changing, double-blind clinical trial in which 881 patients were randomized to initiation of sacubitril/valsartan (Entresto) or enalapril during hospitalization for acute decompensated heart failure. In the previously reported main outcome, 8 weeks after discharge the sacubitril/valsartan group had a 29% greater reduction in NT-proBNP (the N-terminal prohormone of brain natriuretic peptide) and a 42% lower rate of the composite clinical endpoint of cardiovascular death or heart failure rehospitalization than the enalapril group (N Engl J Med. 2019 Feb 7;380[6]:539-48).

The 4-week open-label extension of PIONEER-HF began at week 8, when participants initially randomized to enalapril during the double-blind phase were switched to sacubitril/valsartan, while those assigned to in-hospital initiation of the angiotensin-neprilysin inhibitor (ARNI) stayed the course.

At week 12, after 4 weeks of open-label treatment, patients on sacubitril/valsartan from the start experienced an additional 18.5% drop in NT-proBNP from their week-8 baseline of 1,218 pg/mL. Meanwhile, the NT-proBNP level in the switch group plunged by 35.8% from a week-8 baseline of 1,630 pg/mL. As a result, both groups ended up at the same much-improved biomarker level at week 12, observed Dr. DeVore, a cardiologist at Duke University in Durham, N.C.

Clinical event rates, however, were another story altogether. The clinical event gap between the two study arms documented at week 8 in the double-blind phase of the trial didn’t close significantly in the 4 weeks after the enalapril group crossed over to open-label sacubitril/valsartan. Indeed, the relative risk of the composite endpoint of cardiovascular death, heart failure rehospitalization, or left ventricular assist device implantation during the 4-week extension phase was 33% lower in the continuous sacubitril/valsartan group than in the switchers. The absolute risk reduction was 5.6%, with a favorable number needed to treat of 18.

This difference was driven mainly by less rehospitalization for heart failure. Few cardiovascular deaths or LVAD implantations occurred during the relatively brief 4-week extension phase of the trial.

“But this is an important thing as we think about what we’re trying to accomplish in heart failure: trying to find tools that improve rehospitalization rates after people leave the hospital is extremely important,” Dr. DeVore said. “We do know that the really vulnerable period for rehospitalization is early on, so my sus```picion – though I can’t prove it – is that’s the important part. That’s when we need to have patients on the best therapy.”

He was asked how practical it is to initiate sacubitril/valsartan during hospitalization for acute decompensated heart failure in real-world clinical practice, given that it can be done only after patients achieve hemodynamic stability.

“I think the definition of hemodynamic stability we used in the trial was a fairly straightforward one, very clinical, and one we can translate to the bedside,” Dr. DeVore replied. “Patients had to have a systolic blood pressure of 100 mm Hg or greater for 6 hours, which is easily documented in the hospital, no changes in IV diuretics or IV vasodilators for 6 hours, and no IV inotropes for the last 24 hours. That’s how we defined hemodynamic stability. I think we should be able to find these patients.”

Average length of stay in the index hospitalization in PIONEER-HF was just over 5 days, but the study protocol actually resulted in longer-than-needed hospitalization because it required that patients had to receive three double-blind doses of their study medication before discharge. In routine practice, it’s unlikely that in-hospital initiation of sacubitril/valsartan will result in a length of stay greater than the national average of about 4.5 days, according the cardiologist.

Current ACC/American Heart Association/Heart Failure Society of American guidelines on management of heart failure include a Class Ia recommendation to switch patients from an ACE inhibitor or angiotensin inhibitor to sacubitril/valsartan (Circulation. 2017 Aug 8;136[6]:e137-61).

However, heart failure specialists are concerned by national data showing that sacubitril/valsartan remains widely underprescribed.

Dr. DeVore reported serving as a consultant to Novartis and receiving research grants from a half dozen pharmaceutical companies as well as the American Heart Association, National Heart, Lung, and Blood Institute, and the Patient-Centered Outcomes Research Institute .

[email protected]

The Food and Drug Administration has announced a potential temporary shortage of a type of Bivona tracheostomy tube manufactured by Smiths Medical caused by the closure of a large ethylene oxide sterilization facilities in Willowbrook, Ill., and the future planned closure of a similar facility.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The shortage may affect pediatric use because, although tubes are used for both adults and children, there are fewer alternative products on the market for pediatric patients. Parents and caregivers of children who use the Bivona tube are encouraged to check with Smiths Medical about available inventory and with their health care providers about alternative products.

Jeff Shuren, MD, director of the Center for Devices and Radiological Health, wrote in a press release, “I want to assure you that the FDA is working closely with the company to quickly resolve their sterilization challenges and bring these critical devices to the patients who need them as quickly as possible, which we anticipate will be made available again beginning the week of April 22.”

For patients currently using the Bivona tubes, Dr. Shuren noted, “The closure of the Willowbrook facility does not impact tubes already in use by patients at home or in health care settings. The company is communicating with patients about the tubes and how patients and caregivers can mitigate any potential impact, including reusing and cleaning tubes in accordance with the manufacturer’s instructions for use.”

Read the entire announcement at the FDA website.

[email protected]

The Food and Drug Administration has announced a potential temporary shortage of a type of Bivona tracheostomy tube manufactured by Smiths Medical caused by the closure of a large ethylene oxide sterilization facilities in Willowbrook, Ill., and the future planned closure of a similar facility.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The shortage may affect pediatric use because, although tubes are used for both adults and children, there are fewer alternative products on the market for pediatric patients. Parents and caregivers of children who use the Bivona tube are encouraged to check with Smiths Medical about available inventory and with their health care providers about alternative products.

Jeff Shuren, MD, director of the Center for Devices and Radiological Health, wrote in a press release, “I want to assure you that the FDA is working closely with the company to quickly resolve their sterilization challenges and bring these critical devices to the patients who need them as quickly as possible, which we anticipate will be made available again beginning the week of April 22.”

For patients currently using the Bivona tubes, Dr. Shuren noted, “The closure of the Willowbrook facility does not impact tubes already in use by patients at home or in health care settings. The company is communicating with patients about the tubes and how patients and caregivers can mitigate any potential impact, including reusing and cleaning tubes in accordance with the manufacturer’s instructions for use.”

Read the entire announcement at the FDA website.

[email protected]

The Food and Drug Administration has announced a potential temporary shortage of a type of Bivona tracheostomy tube manufactured by Smiths Medical caused by the closure of a large ethylene oxide sterilization facilities in Willowbrook, Ill., and the future planned closure of a similar facility.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The shortage may affect pediatric use because, although tubes are used for both adults and children, there are fewer alternative products on the market for pediatric patients. Parents and caregivers of children who use the Bivona tube are encouraged to check with Smiths Medical about available inventory and with their health care providers about alternative products.

Jeff Shuren, MD, director of the Center for Devices and Radiological Health, wrote in a press release, “I want to assure you that the FDA is working closely with the company to quickly resolve their sterilization challenges and bring these critical devices to the patients who need them as quickly as possible, which we anticipate will be made available again beginning the week of April 22.”

For patients currently using the Bivona tubes, Dr. Shuren noted, “The closure of the Willowbrook facility does not impact tubes already in use by patients at home or in health care settings. The company is communicating with patients about the tubes and how patients and caregivers can mitigate any potential impact, including reusing and cleaning tubes in accordance with the manufacturer’s instructions for use.”

Read the entire announcement at the FDA website.

[email protected]

PHILADELPHIA – Opening the door to transformational change can be as simple as opening a door.

Gregory Twachtman/MDedge News

At least one physician can attest to this.

Priya Radhakrishnan, MD, chief academic officer at HonorHealth Medical Group, Phoenix, described one of her earliest successes in working on the Transforming Clinical Practice Initiative as her literal and figurative opening of the door between a behavioral health office and a physician health office.

In her example, which she presented in a panel on transformational change at the annual meeting of the American College of Physicians, both the behavioral health office and the physician office coordinated to have the same Medicaid patients. Because of that, when the behavioral health specialist learned of a physical condition, a “warm hand-off” was made simply by walking the patient into the doctor’s office, she said.

Transformational changes in the delivery of health care can come from events and opportunities within your medical practice. And your practice data can be the tools that guide you to make the change happen, noted Dr. Radhakrishnan and her copanelists, during the April 12 session. The panelists focused their presentation on lessons learned from the ongoing Transforming Clinical Practice Initiative, a test project of the Centers for Medicare & Medicaid Services’ Center for Medicare and Medicaid Innovation. The project is providing assistance to physicians and practices looking to transform their organizations into using value-based care delivery models.

“I think most of us don’t realize how much power we hold over the ability to change health care within our neighborhood,” said Thomas Spain, MD, of Vanderbilt University Medical Center, Nashville, Tenn., during his presentation. “[We] have been lulled into this idea that health care will change ... when someone in Washington, D.C., finally makes a change.”

Actually, specific events in a single practice typically drive changes, he said. Most physicians who made these changes “really had very little interest in [practice changes]; then something would happen. It was a patient experience that they had, a family experience, a new program that came along” that made them realize there is an opportunity here for a physician to take the lead and make a change.

And, invariably, those physicians discovered “new satisfaction in their work through the process ... [their] practices looked very different at the end of the project,” Dr. Spain noted.

The other component to the success was looking differently at data to assure continuous data-driven quality improvement, said copanelist M. Carol Greenlee, MD, an endocrinologist and chair and counsel of subspecialty societies at ACP.

Data aren’t just about “being judged [and] not getting penalized,” she said. Data need to be viewed as a tool to really help understand the needs of the patient and the population.

Change makers “had to [ask], ‘For my population, how do I reduce admissions, what are the unnecessary tests my patients are getting, what are the unnecessary procedures?’ ” she said. Through the Transforming Clinical Practice Initiative, “we are teaching [participants] how to use data to show their value to payers ... and to find their voice in sharing their value.”

Some of the aims of the program included building solutions that were scalable, reducing unnecessary hospital admissions, generating $1 billion to $4 billion in savings, and transitioning 75% of practices completing the program to alternative payment models.

Dr. Spain noted that something as simple as moving the “if this is a medical emergency” disclaimer to the end of the outbound message at the physician office could help reduce trips to the emergency department. This could instead bring the patient to the office.

“Start small,” Dr. Radhakrishnan advised. “Value and quality freaks all of us out.”

Target small successes that can be built upon.

“Care delivery is the final mile,” Dr. Greenlee added. “We have all this medical knowledge, all the science and clinical research, and we know what to do with our guidelines, but if we don’t have care delivery, that final mile of [improving] ... the health of our patients, all of this is for naught.”

[email protected]

PHILADELPHIA – Opening the door to transformational change can be as simple as opening a door.

Gregory Twachtman/MDedge News

At least one physician can attest to this.

Priya Radhakrishnan, MD, chief academic officer at HonorHealth Medical Group, Phoenix, described one of her earliest successes in working on the Transforming Clinical Practice Initiative as her literal and figurative opening of the door between a behavioral health office and a physician health office.

In her example, which she presented in a panel on transformational change at the annual meeting of the American College of Physicians, both the behavioral health office and the physician office coordinated to have the same Medicaid patients. Because of that, when the behavioral health specialist learned of a physical condition, a “warm hand-off” was made simply by walking the patient into the doctor’s office, she said.

Transformational changes in the delivery of health care can come from events and opportunities within your medical practice. And your practice data can be the tools that guide you to make the change happen, noted Dr. Radhakrishnan and her copanelists, during the April 12 session. The panelists focused their presentation on lessons learned from the ongoing Transforming Clinical Practice Initiative, a test project of the Centers for Medicare & Medicaid Services’ Center for Medicare and Medicaid Innovation. The project is providing assistance to physicians and practices looking to transform their organizations into using value-based care delivery models.

“I think most of us don’t realize how much power we hold over the ability to change health care within our neighborhood,” said Thomas Spain, MD, of Vanderbilt University Medical Center, Nashville, Tenn., during his presentation. “[We] have been lulled into this idea that health care will change ... when someone in Washington, D.C., finally makes a change.”

Actually, specific events in a single practice typically drive changes, he said. Most physicians who made these changes “really had very little interest in [practice changes]; then something would happen. It was a patient experience that they had, a family experience, a new program that came along” that made them realize there is an opportunity here for a physician to take the lead and make a change.

And, invariably, those physicians discovered “new satisfaction in their work through the process ... [their] practices looked very different at the end of the project,” Dr. Spain noted.

The other component to the success was looking differently at data to assure continuous data-driven quality improvement, said copanelist M. Carol Greenlee, MD, an endocrinologist and chair and counsel of subspecialty societies at ACP.

Data aren’t just about “being judged [and] not getting penalized,” she said. Data need to be viewed as a tool to really help understand the needs of the patient and the population.

Change makers “had to [ask], ‘For my population, how do I reduce admissions, what are the unnecessary tests my patients are getting, what are the unnecessary procedures?’ ” she said. Through the Transforming Clinical Practice Initiative, “we are teaching [participants] how to use data to show their value to payers ... and to find their voice in sharing their value.”

Some of the aims of the program included building solutions that were scalable, reducing unnecessary hospital admissions, generating $1 billion to $4 billion in savings, and transitioning 75% of practices completing the program to alternative payment models.

Dr. Spain noted that something as simple as moving the “if this is a medical emergency” disclaimer to the end of the outbound message at the physician office could help reduce trips to the emergency department. This could instead bring the patient to the office.

“Start small,” Dr. Radhakrishnan advised. “Value and quality freaks all of us out.”

Target small successes that can be built upon.

“Care delivery is the final mile,” Dr. Greenlee added. “We have all this medical knowledge, all the science and clinical research, and we know what to do with our guidelines, but if we don’t have care delivery, that final mile of [improving] ... the health of our patients, all of this is for naught.”

[email protected]

PHILADELPHIA – Opening the door to transformational change can be as simple as opening a door.

Gregory Twachtman/MDedge News

At least one physician can attest to this.

Priya Radhakrishnan, MD, chief academic officer at HonorHealth Medical Group, Phoenix, described one of her earliest successes in working on the Transforming Clinical Practice Initiative as her literal and figurative opening of the door between a behavioral health office and a physician health office.

In her example, which she presented in a panel on transformational change at the annual meeting of the American College of Physicians, both the behavioral health office and the physician office coordinated to have the same Medicaid patients. Because of that, when the behavioral health specialist learned of a physical condition, a “warm hand-off” was made simply by walking the patient into the doctor’s office, she said.

Transformational changes in the delivery of health care can come from events and opportunities within your medical practice. And your practice data can be the tools that guide you to make the change happen, noted Dr. Radhakrishnan and her copanelists, during the April 12 session. The panelists focused their presentation on lessons learned from the ongoing Transforming Clinical Practice Initiative, a test project of the Centers for Medicare & Medicaid Services’ Center for Medicare and Medicaid Innovation. The project is providing assistance to physicians and practices looking to transform their organizations into using value-based care delivery models.

“I think most of us don’t realize how much power we hold over the ability to change health care within our neighborhood,” said Thomas Spain, MD, of Vanderbilt University Medical Center, Nashville, Tenn., during his presentation. “[We] have been lulled into this idea that health care will change ... when someone in Washington, D.C., finally makes a change.”

Actually, specific events in a single practice typically drive changes, he said. Most physicians who made these changes “really had very little interest in [practice changes]; then something would happen. It was a patient experience that they had, a family experience, a new program that came along” that made them realize there is an opportunity here for a physician to take the lead and make a change.

And, invariably, those physicians discovered “new satisfaction in their work through the process ... [their] practices looked very different at the end of the project,” Dr. Spain noted.

The other component to the success was looking differently at data to assure continuous data-driven quality improvement, said copanelist M. Carol Greenlee, MD, an endocrinologist and chair and counsel of subspecialty societies at ACP.

Data aren’t just about “being judged [and] not getting penalized,” she said. Data need to be viewed as a tool to really help understand the needs of the patient and the population.

Change makers “had to [ask], ‘For my population, how do I reduce admissions, what are the unnecessary tests my patients are getting, what are the unnecessary procedures?’ ” she said. Through the Transforming Clinical Practice Initiative, “we are teaching [participants] how to use data to show their value to payers ... and to find their voice in sharing their value.”

Some of the aims of the program included building solutions that were scalable, reducing unnecessary hospital admissions, generating $1 billion to $4 billion in savings, and transitioning 75% of practices completing the program to alternative payment models.

Dr. Spain noted that something as simple as moving the “if this is a medical emergency” disclaimer to the end of the outbound message at the physician office could help reduce trips to the emergency department. This could instead bring the patient to the office.

“Start small,” Dr. Radhakrishnan advised. “Value and quality freaks all of us out.”

Target small successes that can be built upon.

“Care delivery is the final mile,” Dr. Greenlee added. “We have all this medical knowledge, all the science and clinical research, and we know what to do with our guidelines, but if we don’t have care delivery, that final mile of [improving] ... the health of our patients, all of this is for naught.”

[email protected]

The use of energy-based devices for vaginal rejuvenation, a practice that sparked a recent safety communication from the Food and Drug Administration, was implicated in nearly four dozen adverse event reports found in the agency’s medical device adverse event reporting database, researchers report.

The 45 unique event reports, submitted to the FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said the researchers, led by Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer; 4 reported by the distributor, and 2 not specified.

These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. “Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices,” they wrote.

In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as “vaginal rejuvenation.” Scott Gottlieb, MD, FDA commissioner at the time, issued a statement decrying “deceptive health claims and significant risks” related to devices marketed for those medical procedures. In a November 2018 update, the FDA said they contacted some device manufacturers to express concerns that the devices were being marketed inappropriately and that manufacturers they had contacted so far “responded with adequate corrections.”

In their report, Dr. Ahluwalia and her associates noted that “vaginal rejuvenation” is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.

They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA’s July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.

Pain was the most commonly adverse event, accounting for 19 reports in their analysis, while 11 patients reported numbness or burning.

Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16), the data show. “However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation,” the authors pointed out.

In light of these findings, the authors advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. “Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns,” they added. Concerns about related to genitourinary syndrome of menopause “or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling,” they noted.

The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.

Adverse events related to devices and drugs can be reported to the FDA’s Medwatch program.

SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.

The use of energy-based devices for vaginal rejuvenation, a practice that sparked a recent safety communication from the Food and Drug Administration, was implicated in nearly four dozen adverse event reports found in the agency’s medical device adverse event reporting database, researchers report.

The 45 unique event reports, submitted to the FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said the researchers, led by Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer; 4 reported by the distributor, and 2 not specified.

These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. “Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices,” they wrote.

In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as “vaginal rejuvenation.” Scott Gottlieb, MD, FDA commissioner at the time, issued a statement decrying “deceptive health claims and significant risks” related to devices marketed for those medical procedures. In a November 2018 update, the FDA said they contacted some device manufacturers to express concerns that the devices were being marketed inappropriately and that manufacturers they had contacted so far “responded with adequate corrections.”

In their report, Dr. Ahluwalia and her associates noted that “vaginal rejuvenation” is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.

They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA’s July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.

Pain was the most commonly adverse event, accounting for 19 reports in their analysis, while 11 patients reported numbness or burning.

Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16), the data show. “However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation,” the authors pointed out.

In light of these findings, the authors advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. “Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns,” they added. Concerns about related to genitourinary syndrome of menopause “or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling,” they noted.

The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.

Adverse events related to devices and drugs can be reported to the FDA’s Medwatch program.

SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.

The use of energy-based devices for vaginal rejuvenation, a practice that sparked a recent safety communication from the Food and Drug Administration, was implicated in nearly four dozen adverse event reports found in the agency’s medical device adverse event reporting database, researchers report.

The 45 unique event reports, submitted to the FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said the researchers, led by Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer; 4 reported by the distributor, and 2 not specified.

These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. “Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices,” they wrote.

In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as “vaginal rejuvenation.” Scott Gottlieb, MD, FDA commissioner at the time, issued a statement decrying “deceptive health claims and significant risks” related to devices marketed for those medical procedures. In a November 2018 update, the FDA said they contacted some device manufacturers to express concerns that the devices were being marketed inappropriately and that manufacturers they had contacted so far “responded with adequate corrections.”

In their report, Dr. Ahluwalia and her associates noted that “vaginal rejuvenation” is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.

They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA’s July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.

Pain was the most commonly adverse event, accounting for 19 reports in their analysis, while 11 patients reported numbness or burning.

Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16), the data show. “However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation,” the authors pointed out.

In light of these findings, the authors advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. “Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns,” they added. Concerns about related to genitourinary syndrome of menopause “or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling,” they noted.

The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.

Adverse events related to devices and drugs can be reported to the FDA’s Medwatch program.

SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.

NEW ORLEANS – The 2015 American Thyroid Association risk stratification system for patients with differentiated thyroid cancer performed well in a real-world cohort with a high proportion of high-risk patients, according to a study presented at the annual meeting of the Endocrine Society.

“The 2015 ATA Risk Stratification System is an excellent predictor of both persisting disease and survival,” wrote Evert F.S. van Velsen, MD, and his colleagues at Erasmus Medical Center, Rotterdam, the Netherlands, in a poster accompanying the presentation.

Among a group of 236 patients with differentiated thyroid cancer (DTC), Dr. van Velsen and his coauthors looked at how the ATA high-risk criteria influenced patient response to therapy. By the end of the 14-year study period, initial gross extrathyroidal disease extension meant patients were much less likely to have an excellent response (odds ratio, 0.26; P less than .001), and much more likely to have persistent disease (OR, 2.57; P = .001).

Odds of having an excellent response were reduced by having high postoperative thyroglobulin levels (OR, 0.21; P less than .001), and persistent disease was more likely (OR, 2.39; P = .002).

Other high-risk criteria associated with significantly lower odds of excellent response included distant metastases (OR, 0.36), incomplete resection (OR, 0.51), and having follicular thyroid carcinoma (FTC) with extensive vascular invasion (OR, 0.27). All these risk factors also were associated with higher odds of persistent disease.

“Recurrence after no evidence of disease occurred in 14%” of the study population, said Dr. van Velsen and his coauthors, adding, “Clinicians should be aware of the relatively high recurrence risk, even after an excellent response to therapy.”

The study aimed to evaluate the 2015 ATA risk stratification system’s prognostic value in a population that included a relatively large proportion of high-risk DTC patients, to include many FTC patients. This work, they noted, augments previous assessments of the risk stratification system in lower-risk populations.

The authors noted that, in addition to predicting disease recurrence, the risk stratification system also worked as a predictor of disease-specific survival. Patients with structural incomplete response fared the worst, with a survival probability below 0.5 at 200 months on a Kaplan-Meier curve of disease-specific survival. Survival probability remained at 1.0 for patients with excellent response after first therapy and was intermediate for those with indeterminate response and biochemical incomplete response.

Overall mortality was higher in FTC patients. Over the study period, 31 of the 76 FTC patients (41%) died, compared with 39 of the PTC patients (24%; P = .010). In all, 28% of the FTC patients and 18% of the PTC patients died of thyroid cancer, but this difference didn’t reach statistical significance.

The retrospective study included adults with DTC meeting the 2015 ATA high-risk criteria who were diagnosed and/or treated at Erasmus Medical Center over a 13-year span ending in December 2015.

Overall, the investigators found 236 patients meeting inclusion criteria; 160 had papillary thyroid cancer (PTC), and the remaining 76 had FTC. The latter group were significantly older at baseline than PTC patients (64 versus 53 years), and were significantly less likely to undergo neck dissection (22% versus 55%).

In the full cohort, 96 patients (41%) had one high-risk factor, and an additional 74 (31%) had two risk factors. The remaining patients had three or more risk factors.

There was no between-group difference in the likelihood of receiving radioactive iodine treatment, but those with FTC had a lower cumulative radiation dose (195 versus 298 mCi; P less than .001).

More than half of patients (58%) had persistent disease after completing their first therapy. Of these, 51% had structural incomplete response and 7% had biochemical incomplete response. The response was indeterminate for about a quarter of the cohort, and the remaining 17% had an excellent initial response.

By the end of the study period, 55% of patients had persistent disease, and 51% had structural incomplete response (a more likely result for those with FTC than PTC). Just 4% had a biochemical incomplete response, and the response was indeterminate for 16%. Response was judged excellent for 29% of patients.

Dr. van Velsen and his coauthors reported that they had no relevant disclosures.

[email protected]

SOURCE: van Velsen EFS et al. ENDO 2019, Abstract MON-549.

NEW ORLEANS – The 2015 American Thyroid Association risk stratification system for patients with differentiated thyroid cancer performed well in a real-world cohort with a high proportion of high-risk patients, according to a study presented at the annual meeting of the Endocrine Society.

“The 2015 ATA Risk Stratification System is an excellent predictor of both persisting disease and survival,” wrote Evert F.S. van Velsen, MD, and his colleagues at Erasmus Medical Center, Rotterdam, the Netherlands, in a poster accompanying the presentation.

Among a group of 236 patients with differentiated thyroid cancer (DTC), Dr. van Velsen and his coauthors looked at how the ATA high-risk criteria influenced patient response to therapy. By the end of the 14-year study period, initial gross extrathyroidal disease extension meant patients were much less likely to have an excellent response (odds ratio, 0.26; P less than .001), and much more likely to have persistent disease (OR, 2.57; P = .001).

Odds of having an excellent response were reduced by having high postoperative thyroglobulin levels (OR, 0.21; P less than .001), and persistent disease was more likely (OR, 2.39; P = .002).

Other high-risk criteria associated with significantly lower odds of excellent response included distant metastases (OR, 0.36), incomplete resection (OR, 0.51), and having follicular thyroid carcinoma (FTC) with extensive vascular invasion (OR, 0.27). All these risk factors also were associated with higher odds of persistent disease.

“Recurrence after no evidence of disease occurred in 14%” of the study population, said Dr. van Velsen and his coauthors, adding, “Clinicians should be aware of the relatively high recurrence risk, even after an excellent response to therapy.”

The study aimed to evaluate the 2015 ATA risk stratification system’s prognostic value in a population that included a relatively large proportion of high-risk DTC patients, to include many FTC patients. This work, they noted, augments previous assessments of the risk stratification system in lower-risk populations.

The authors noted that, in addition to predicting disease recurrence, the risk stratification system also worked as a predictor of disease-specific survival. Patients with structural incomplete response fared the worst, with a survival probability below 0.5 at 200 months on a Kaplan-Meier curve of disease-specific survival. Survival probability remained at 1.0 for patients with excellent response after first therapy and was intermediate for those with indeterminate response and biochemical incomplete response.

Overall mortality was higher in FTC patients. Over the study period, 31 of the 76 FTC patients (41%) died, compared with 39 of the PTC patients (24%; P = .010). In all, 28% of the FTC patients and 18% of the PTC patients died of thyroid cancer, but this difference didn’t reach statistical significance.

The retrospective study included adults with DTC meeting the 2015 ATA high-risk criteria who were diagnosed and/or treated at Erasmus Medical Center over a 13-year span ending in December 2015.

Overall, the investigators found 236 patients meeting inclusion criteria; 160 had papillary thyroid cancer (PTC), and the remaining 76 had FTC. The latter group were significantly older at baseline than PTC patients (64 versus 53 years), and were significantly less likely to undergo neck dissection (22% versus 55%).

In the full cohort, 96 patients (41%) had one high-risk factor, and an additional 74 (31%) had two risk factors. The remaining patients had three or more risk factors.

There was no between-group difference in the likelihood of receiving radioactive iodine treatment, but those with FTC had a lower cumulative radiation dose (195 versus 298 mCi; P less than .001).

More than half of patients (58%) had persistent disease after completing their first therapy. Of these, 51% had structural incomplete response and 7% had biochemical incomplete response. The response was indeterminate for about a quarter of the cohort, and the remaining 17% had an excellent initial response.

By the end of the study period, 55% of patients had persistent disease, and 51% had structural incomplete response (a more likely result for those with FTC than PTC). Just 4% had a biochemical incomplete response, and the response was indeterminate for 16%. Response was judged excellent for 29% of patients.

Dr. van Velsen and his coauthors reported that they had no relevant disclosures.

[email protected]

SOURCE: van Velsen EFS et al. ENDO 2019, Abstract MON-549.

NEW ORLEANS – The 2015 American Thyroid Association risk stratification system for patients with differentiated thyroid cancer performed well in a real-world cohort with a high proportion of high-risk patients, according to a study presented at the annual meeting of the Endocrine Society.

“The 2015 ATA Risk Stratification System is an excellent predictor of both persisting disease and survival,” wrote Evert F.S. van Velsen, MD, and his colleagues at Erasmus Medical Center, Rotterdam, the Netherlands, in a poster accompanying the presentation.

Among a group of 236 patients with differentiated thyroid cancer (DTC), Dr. van Velsen and his coauthors looked at how the ATA high-risk criteria influenced patient response to therapy. By the end of the 14-year study period, initial gross extrathyroidal disease extension meant patients were much less likely to have an excellent response (odds ratio, 0.26; P less than .001), and much more likely to have persistent disease (OR, 2.57; P = .001).

Odds of having an excellent response were reduced by having high postoperative thyroglobulin levels (OR, 0.21; P less than .001), and persistent disease was more likely (OR, 2.39; P = .002).

Other high-risk criteria associated with significantly lower odds of excellent response included distant metastases (OR, 0.36), incomplete resection (OR, 0.51), and having follicular thyroid carcinoma (FTC) with extensive vascular invasion (OR, 0.27). All these risk factors also were associated with higher odds of persistent disease.

“Recurrence after no evidence of disease occurred in 14%” of the study population, said Dr. van Velsen and his coauthors, adding, “Clinicians should be aware of the relatively high recurrence risk, even after an excellent response to therapy.”

The study aimed to evaluate the 2015 ATA risk stratification system’s prognostic value in a population that included a relatively large proportion of high-risk DTC patients, to include many FTC patients. This work, they noted, augments previous assessments of the risk stratification system in lower-risk populations.

The authors noted that, in addition to predicting disease recurrence, the risk stratification system also worked as a predictor of disease-specific survival. Patients with structural incomplete response fared the worst, with a survival probability below 0.5 at 200 months on a Kaplan-Meier curve of disease-specific survival. Survival probability remained at 1.0 for patients with excellent response after first therapy and was intermediate for those with indeterminate response and biochemical incomplete response.

Overall mortality was higher in FTC patients. Over the study period, 31 of the 76 FTC patients (41%) died, compared with 39 of the PTC patients (24%; P = .010). In all, 28% of the FTC patients and 18% of the PTC patients died of thyroid cancer, but this difference didn’t reach statistical significance.

The retrospective study included adults with DTC meeting the 2015 ATA high-risk criteria who were diagnosed and/or treated at Erasmus Medical Center over a 13-year span ending in December 2015.

Overall, the investigators found 236 patients meeting inclusion criteria; 160 had papillary thyroid cancer (PTC), and the remaining 76 had FTC. The latter group were significantly older at baseline than PTC patients (64 versus 53 years), and were significantly less likely to undergo neck dissection (22% versus 55%).

In the full cohort, 96 patients (41%) had one high-risk factor, and an additional 74 (31%) had two risk factors. The remaining patients had three or more risk factors.

There was no between-group difference in the likelihood of receiving radioactive iodine treatment, but those with FTC had a lower cumulative radiation dose (195 versus 298 mCi; P less than .001).

More than half of patients (58%) had persistent disease after completing their first therapy. Of these, 51% had structural incomplete response and 7% had biochemical incomplete response. The response was indeterminate for about a quarter of the cohort, and the remaining 17% had an excellent initial response.

By the end of the study period, 55% of patients had persistent disease, and 51% had structural incomplete response (a more likely result for those with FTC than PTC). Just 4% had a biochemical incomplete response, and the response was indeterminate for 16%. Response was judged excellent for 29% of patients.

Dr. van Velsen and his coauthors reported that they had no relevant disclosures.

[email protected]

SOURCE: van Velsen EFS et al. ENDO 2019, Abstract MON-549.

DENVER – Oral low-dose isotretinoin in combination with pulsed dye laser achieves high percentage of papulopustular rosacea clearance with a low risk of side effects, results from a single-center study found.

“Rosacea has been classically treated with topical and oral antibiotics, retinoids or ivermectin, and it is really important to enhance laser contribution for rosacea clearance,” lead study author Natalia Jiménez Gómez, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “Our work points to the high efficacy of a scarcely published combination treatment: low-dose oral isotretinoin and pulsed dye laser. Moreover, this combined treatment is employed in papulopustular rosacea, a clinical form that is usually treated without employing physical methods.”

For the study, Dr. Gómez and her colleagues retrospectively analyzed 40 patients with moderate or severe papulopustular rosacea who underwent concomitant treatment of pulsed dye laser and low-dose oral isotretinoin (5-10 mg/day). Pulsed dye laser sessions were performed with a 10-mm spot size at a pulse duration of 0.5 milliseconds delivered at a fluence of 8 J/cm² every 3-4 weeks in combination with low-dose oral isotretinoin during 4- to 6-month periods. The treatment endpoint was purpura. Five patients were withdrawn from the analysis because of loss to follow-up or to a lack of clinical images.

All 35 patients achieved a complete clearance of papulopustular lesions of rosacea within 7-10 days, said Dr. Gómez, who practices at the Madrid-based Hospital Universitario Ramón y Cajal. The researchers did not observe any permanent adverse events such as scarring, hyperpigmentation, or hypopigmentation.

“The most surprising finding was the high percentage of rosacea clearance obtained with the combined treatment, considering that all the patients were previously nonresponsive to oral low-dose isotretinoin monotherapy,” Dr. Gómez said. “This finding highlights the important role of pulsed dye laser.”

She acknowledged certain limitations of the study, including its retrospective design and small sample size. “It would also be interesting to compare pulsed dye laser with intense pulsed light, so that we can conclude if one of them is more effective than the other when we combine it with low dose oral isotretinoin,” she said.

Dr. Gómez reported having no financial disclosures.

[email protected]

DENVER – Oral low-dose isotretinoin in combination with pulsed dye laser achieves high percentage of papulopustular rosacea clearance with a low risk of side effects, results from a single-center study found.

“Rosacea has been classically treated with topical and oral antibiotics, retinoids or ivermectin, and it is really important to enhance laser contribution for rosacea clearance,” lead study author Natalia Jiménez Gómez, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “Our work points to the high efficacy of a scarcely published combination treatment: low-dose oral isotretinoin and pulsed dye laser. Moreover, this combined treatment is employed in papulopustular rosacea, a clinical form that is usually treated without employing physical methods.”

For the study, Dr. Gómez and her colleagues retrospectively analyzed 40 patients with moderate or severe papulopustular rosacea who underwent concomitant treatment of pulsed dye laser and low-dose oral isotretinoin (5-10 mg/day). Pulsed dye laser sessions were performed with a 10-mm spot size at a pulse duration of 0.5 milliseconds delivered at a fluence of 8 J/cm² every 3-4 weeks in combination with low-dose oral isotretinoin during 4- to 6-month periods. The treatment endpoint was purpura. Five patients were withdrawn from the analysis because of loss to follow-up or to a lack of clinical images.

All 35 patients achieved a complete clearance of papulopustular lesions of rosacea within 7-10 days, said Dr. Gómez, who practices at the Madrid-based Hospital Universitario Ramón y Cajal. The researchers did not observe any permanent adverse events such as scarring, hyperpigmentation, or hypopigmentation.

“The most surprising finding was the high percentage of rosacea clearance obtained with the combined treatment, considering that all the patients were previously nonresponsive to oral low-dose isotretinoin monotherapy,” Dr. Gómez said. “This finding highlights the important role of pulsed dye laser.”

She acknowledged certain limitations of the study, including its retrospective design and small sample size. “It would also be interesting to compare pulsed dye laser with intense pulsed light, so that we can conclude if one of them is more effective than the other when we combine it with low dose oral isotretinoin,” she said.

Dr. Gómez reported having no financial disclosures.

[email protected]

DENVER – Oral low-dose isotretinoin in combination with pulsed dye laser achieves high percentage of papulopustular rosacea clearance with a low risk of side effects, results from a single-center study found.

“Rosacea has been classically treated with topical and oral antibiotics, retinoids or ivermectin, and it is really important to enhance laser contribution for rosacea clearance,” lead study author Natalia Jiménez Gómez, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “Our work points to the high efficacy of a scarcely published combination treatment: low-dose oral isotretinoin and pulsed dye laser. Moreover, this combined treatment is employed in papulopustular rosacea, a clinical form that is usually treated without employing physical methods.”

For the study, Dr. Gómez and her colleagues retrospectively analyzed 40 patients with moderate or severe papulopustular rosacea who underwent concomitant treatment of pulsed dye laser and low-dose oral isotretinoin (5-10 mg/day). Pulsed dye laser sessions were performed with a 10-mm spot size at a pulse duration of 0.5 milliseconds delivered at a fluence of 8 J/cm² every 3-4 weeks in combination with low-dose oral isotretinoin during 4- to 6-month periods. The treatment endpoint was purpura. Five patients were withdrawn from the analysis because of loss to follow-up or to a lack of clinical images.

All 35 patients achieved a complete clearance of papulopustular lesions of rosacea within 7-10 days, said Dr. Gómez, who practices at the Madrid-based Hospital Universitario Ramón y Cajal. The researchers did not observe any permanent adverse events such as scarring, hyperpigmentation, or hypopigmentation.

“The most surprising finding was the high percentage of rosacea clearance obtained with the combined treatment, considering that all the patients were previously nonresponsive to oral low-dose isotretinoin monotherapy,” Dr. Gómez said. “This finding highlights the important role of pulsed dye laser.”

She acknowledged certain limitations of the study, including its retrospective design and small sample size. “It would also be interesting to compare pulsed dye laser with intense pulsed light, so that we can conclude if one of them is more effective than the other when we combine it with low dose oral isotretinoin,” she said.

Dr. Gómez reported having no financial disclosures.

[email protected]