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Guselkumab tops adalimumab for psychiatric comorbidities in psoriasis
GENEVA – Guselkumab for treatment of moderate to severe plaque psoriasis generated significantly greater improvement in comorbid anxiety and depression than adalimumab in the head-to-head VOYAGE 2 randomized trial, Kenneth B. Gordon, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The population enrolled in VOYAGE 2, which did not preselect to enrich the study population for anxiety and depression, reflected how common these mental health problems are among psoriasis patients. Fully 38.6% of the 992 randomized patients had a baseline Hospital Anxiety and Depression Score-Anxiety (HADS-A) of 8 or more (considered clinically important anxiety) on the 0-21 scale, and 27.7% had a HADS-D score of at least 8 (indicative of clinically meaningful depression), noted Dr. Gordon, professor and chair of dermatology at the Medical College of Wisconsin, Milwaukee.
The on-treatment reductions in psychiatric symptoms in VOYAGE 2 correlated closely with greater improvement in psoriasis, he added. For example, regardless of which drug they were on, patients with a baseline HADS-D of 8 or more averaged a 3.6-point reduction in HADS-D at week 24 if, at that point, they had a Psoriasis Area Severity Index (PASI) response of 75-89, a 4.0-point improvement if they had a PASI 90-99 response, and a 5.2-point reduction in HADS-D if they had a PASI 100 response.
VOYAGE 2 was a phase 3, double-blind, multicenter, placebo-controlled comparison of guselkumab (Tremfya), a human monoclonal antibody targeting the interleukin-23 p 19 subunit, and the tumor necrosis factor-alpha inhibitor adalimumab (Humira) in their standard dosing. Participants were randomized 2:1:1 to guselkumab, adalimumab, or placebo. The study’s primary outcomes have previously been reported (J Am Acad Dermatol. 2017 Mar;76[3]:418-31). For example, at week 24 the guselkumab group demonstrated PASI 75, 90, and 100 responses of 89.1%, 75.2%, and 44.2%, respectively, compared with adalimumab, with PASI 75, 90, and 100 responses of 71%, 54.8%, and 26.6%.
Serial measurement of anxiety and depression symptoms using the HADS-A and HADS-D were part of the study protocol. The mean baseline HADS-A and HADS-D scores were 6.8 and 5.3. At week 24, the mean reduction in the HADS-A score was 2.0 points in the guselkumab group, compared with 1.0 point in the adalimumab arm. HADS-D scores improved by 1.7 and 1.1 points, respectively, in the overall guselkumab and adalimumab groups.
More importantly, among patients with a baseline HADS-A of 8 or higher, by week 16 of the trial, the HADS-A score had dropped below 8 in 51.4% of those on guselkumab, compared with 44.9% of patients on adalimumab and 25.9% on placebo, Dr. Gordon reported. Similarly, 59.2% of guselkumab-treated patients with a high baseline HADS-D improved to a score below 8 at week 16, compared with 54.3% on adalimumab and 27% on placebo.
At week 24, 58.4% of guselkumab-treated patients with a high baseline HADS-A and 59.4% of those with a high HADS-D had scores below 8. Again, these responses were significantly better than the 42.9% and 46.4% rates, respectively, in the adalimumab arm.
VOYAGE 2 was sponsored by Janssen, which markets guselkumab, approved by the Food and Drug Administration in July 2017 for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Dr. Gordon reported receiving research support from and serving as a consultant to Janssen and numerous other pharmaceutical companies.
GENEVA – Guselkumab for treatment of moderate to severe plaque psoriasis generated significantly greater improvement in comorbid anxiety and depression than adalimumab in the head-to-head VOYAGE 2 randomized trial, Kenneth B. Gordon, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The population enrolled in VOYAGE 2, which did not preselect to enrich the study population for anxiety and depression, reflected how common these mental health problems are among psoriasis patients. Fully 38.6% of the 992 randomized patients had a baseline Hospital Anxiety and Depression Score-Anxiety (HADS-A) of 8 or more (considered clinically important anxiety) on the 0-21 scale, and 27.7% had a HADS-D score of at least 8 (indicative of clinically meaningful depression), noted Dr. Gordon, professor and chair of dermatology at the Medical College of Wisconsin, Milwaukee.
The on-treatment reductions in psychiatric symptoms in VOYAGE 2 correlated closely with greater improvement in psoriasis, he added. For example, regardless of which drug they were on, patients with a baseline HADS-D of 8 or more averaged a 3.6-point reduction in HADS-D at week 24 if, at that point, they had a Psoriasis Area Severity Index (PASI) response of 75-89, a 4.0-point improvement if they had a PASI 90-99 response, and a 5.2-point reduction in HADS-D if they had a PASI 100 response.
VOYAGE 2 was a phase 3, double-blind, multicenter, placebo-controlled comparison of guselkumab (Tremfya), a human monoclonal antibody targeting the interleukin-23 p 19 subunit, and the tumor necrosis factor-alpha inhibitor adalimumab (Humira) in their standard dosing. Participants were randomized 2:1:1 to guselkumab, adalimumab, or placebo. The study’s primary outcomes have previously been reported (J Am Acad Dermatol. 2017 Mar;76[3]:418-31). For example, at week 24 the guselkumab group demonstrated PASI 75, 90, and 100 responses of 89.1%, 75.2%, and 44.2%, respectively, compared with adalimumab, with PASI 75, 90, and 100 responses of 71%, 54.8%, and 26.6%.
Serial measurement of anxiety and depression symptoms using the HADS-A and HADS-D were part of the study protocol. The mean baseline HADS-A and HADS-D scores were 6.8 and 5.3. At week 24, the mean reduction in the HADS-A score was 2.0 points in the guselkumab group, compared with 1.0 point in the adalimumab arm. HADS-D scores improved by 1.7 and 1.1 points, respectively, in the overall guselkumab and adalimumab groups.
More importantly, among patients with a baseline HADS-A of 8 or higher, by week 16 of the trial, the HADS-A score had dropped below 8 in 51.4% of those on guselkumab, compared with 44.9% of patients on adalimumab and 25.9% on placebo, Dr. Gordon reported. Similarly, 59.2% of guselkumab-treated patients with a high baseline HADS-D improved to a score below 8 at week 16, compared with 54.3% on adalimumab and 27% on placebo.
At week 24, 58.4% of guselkumab-treated patients with a high baseline HADS-A and 59.4% of those with a high HADS-D had scores below 8. Again, these responses were significantly better than the 42.9% and 46.4% rates, respectively, in the adalimumab arm.
VOYAGE 2 was sponsored by Janssen, which markets guselkumab, approved by the Food and Drug Administration in July 2017 for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Dr. Gordon reported receiving research support from and serving as a consultant to Janssen and numerous other pharmaceutical companies.
GENEVA – Guselkumab for treatment of moderate to severe plaque psoriasis generated significantly greater improvement in comorbid anxiety and depression than adalimumab in the head-to-head VOYAGE 2 randomized trial, Kenneth B. Gordon, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The population enrolled in VOYAGE 2, which did not preselect to enrich the study population for anxiety and depression, reflected how common these mental health problems are among psoriasis patients. Fully 38.6% of the 992 randomized patients had a baseline Hospital Anxiety and Depression Score-Anxiety (HADS-A) of 8 or more (considered clinically important anxiety) on the 0-21 scale, and 27.7% had a HADS-D score of at least 8 (indicative of clinically meaningful depression), noted Dr. Gordon, professor and chair of dermatology at the Medical College of Wisconsin, Milwaukee.
The on-treatment reductions in psychiatric symptoms in VOYAGE 2 correlated closely with greater improvement in psoriasis, he added. For example, regardless of which drug they were on, patients with a baseline HADS-D of 8 or more averaged a 3.6-point reduction in HADS-D at week 24 if, at that point, they had a Psoriasis Area Severity Index (PASI) response of 75-89, a 4.0-point improvement if they had a PASI 90-99 response, and a 5.2-point reduction in HADS-D if they had a PASI 100 response.
VOYAGE 2 was a phase 3, double-blind, multicenter, placebo-controlled comparison of guselkumab (Tremfya), a human monoclonal antibody targeting the interleukin-23 p 19 subunit, and the tumor necrosis factor-alpha inhibitor adalimumab (Humira) in their standard dosing. Participants were randomized 2:1:1 to guselkumab, adalimumab, or placebo. The study’s primary outcomes have previously been reported (J Am Acad Dermatol. 2017 Mar;76[3]:418-31). For example, at week 24 the guselkumab group demonstrated PASI 75, 90, and 100 responses of 89.1%, 75.2%, and 44.2%, respectively, compared with adalimumab, with PASI 75, 90, and 100 responses of 71%, 54.8%, and 26.6%.
Serial measurement of anxiety and depression symptoms using the HADS-A and HADS-D were part of the study protocol. The mean baseline HADS-A and HADS-D scores were 6.8 and 5.3. At week 24, the mean reduction in the HADS-A score was 2.0 points in the guselkumab group, compared with 1.0 point in the adalimumab arm. HADS-D scores improved by 1.7 and 1.1 points, respectively, in the overall guselkumab and adalimumab groups.
More importantly, among patients with a baseline HADS-A of 8 or higher, by week 16 of the trial, the HADS-A score had dropped below 8 in 51.4% of those on guselkumab, compared with 44.9% of patients on adalimumab and 25.9% on placebo, Dr. Gordon reported. Similarly, 59.2% of guselkumab-treated patients with a high baseline HADS-D improved to a score below 8 at week 16, compared with 54.3% on adalimumab and 27% on placebo.
At week 24, 58.4% of guselkumab-treated patients with a high baseline HADS-A and 59.4% of those with a high HADS-D had scores below 8. Again, these responses were significantly better than the 42.9% and 46.4% rates, respectively, in the adalimumab arm.
VOYAGE 2 was sponsored by Janssen, which markets guselkumab, approved by the Food and Drug Administration in July 2017 for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Dr. Gordon reported receiving research support from and serving as a consultant to Janssen and numerous other pharmaceutical companies.
AT THE EADV CONGRESS
Key clinical point:
Major finding: Fifty-nine percent of gesulkumab-treated patients with moderate to severe psoriasis and clinically significant depression at baseline were below the depression threshold at week 24, compared with 46% of adalimumab-treated patients.
Data source: A phase 3, double-blind, multicenter, placebo-controlled comparison of guselkumab and adalimumab in 992 randomized patients with moderate to severe psoriasis.
Disclosures: VOYAGE 2 was sponsored by Janssen, which markets guselkumab. The presenter reported receiving research support from and serving as a consultant to Janssen and numerous other pharmaceutical companies.
Atrial fibrillation boosts VTE risk
BARCELONA – Atrial fibrillation is at least as strong a risk factor for venous thromboembolism as for ischemic stroke, Bjorn Hornestam, MD, asserted at the annual congress of the European Society of Cardiology.
This novel finding from a Swedish national registry study suggests it’s time for thoughtful consideration of a revision of risk scores in patients with atrial fibrillation (AF), according to Dr. Hornestam, director of cardiology at Sahlgrenska University Hospital in Gothenburg, Sweden.
“VTE risk is not included as an outcome in the CHA2DS2-VASc score, so we underestimate the total thromboembolic risk in AF patients,” he said.
Dr. Hornestam presented a Swedish registry study of 1.36 million patients, including 470,738 patients with new-onset AF and no previous diagnosis of VTE or ischemic stroke and twice as many controls without AF who were matched to the AF patients by age, gender, and county.
The VTE risk was highest during the first 30 days after diagnosis of AF. Women with new-onset AF had an 8.3-fold increased risk of VTE compared with controls during this early period, by a margin of 55.8 versus 6.4 cases per 1,000 person-years. Men with newly diagnosed AF had a 7.2-fold increased risk of VTE in the first 30 days, reflecting a rate of 40.1 per 1,000 person-years compared to 5.6 per 1,000 in controls.
The VTE risk dropped off precipitously in men after the first month. The rate was cut in half by 2 months after AF diagnosis and was no different from that of controls by 9 months.
In women, too, the early elevated VTE risk was halved by 2 months out, but thereafter the rate of decline in VTE risk slowed. Even 10 years after AF diagnosis, women had a 21% greater VTE risk than did matched controls.
Of note, the risk of VTE during the first 12 months after diagnosis of AF was nearly twice as great in both men and women under age 65 than in those older than 75.
These data raise the question of whether standard therapy in AF patients needs to be modified, especially during what now appears to be the critical time frame of the first 3-6 months after diagnosis of the arrhythmia, Dr. Hornestam said.
He reported having no financial conflicts of interest regarding this study.
BARCELONA – Atrial fibrillation is at least as strong a risk factor for venous thromboembolism as for ischemic stroke, Bjorn Hornestam, MD, asserted at the annual congress of the European Society of Cardiology.
This novel finding from a Swedish national registry study suggests it’s time for thoughtful consideration of a revision of risk scores in patients with atrial fibrillation (AF), according to Dr. Hornestam, director of cardiology at Sahlgrenska University Hospital in Gothenburg, Sweden.
“VTE risk is not included as an outcome in the CHA2DS2-VASc score, so we underestimate the total thromboembolic risk in AF patients,” he said.
Dr. Hornestam presented a Swedish registry study of 1.36 million patients, including 470,738 patients with new-onset AF and no previous diagnosis of VTE or ischemic stroke and twice as many controls without AF who were matched to the AF patients by age, gender, and county.
The VTE risk was highest during the first 30 days after diagnosis of AF. Women with new-onset AF had an 8.3-fold increased risk of VTE compared with controls during this early period, by a margin of 55.8 versus 6.4 cases per 1,000 person-years. Men with newly diagnosed AF had a 7.2-fold increased risk of VTE in the first 30 days, reflecting a rate of 40.1 per 1,000 person-years compared to 5.6 per 1,000 in controls.
The VTE risk dropped off precipitously in men after the first month. The rate was cut in half by 2 months after AF diagnosis and was no different from that of controls by 9 months.
In women, too, the early elevated VTE risk was halved by 2 months out, but thereafter the rate of decline in VTE risk slowed. Even 10 years after AF diagnosis, women had a 21% greater VTE risk than did matched controls.
Of note, the risk of VTE during the first 12 months after diagnosis of AF was nearly twice as great in both men and women under age 65 than in those older than 75.
These data raise the question of whether standard therapy in AF patients needs to be modified, especially during what now appears to be the critical time frame of the first 3-6 months after diagnosis of the arrhythmia, Dr. Hornestam said.
He reported having no financial conflicts of interest regarding this study.
BARCELONA – Atrial fibrillation is at least as strong a risk factor for venous thromboembolism as for ischemic stroke, Bjorn Hornestam, MD, asserted at the annual congress of the European Society of Cardiology.
This novel finding from a Swedish national registry study suggests it’s time for thoughtful consideration of a revision of risk scores in patients with atrial fibrillation (AF), according to Dr. Hornestam, director of cardiology at Sahlgrenska University Hospital in Gothenburg, Sweden.
“VTE risk is not included as an outcome in the CHA2DS2-VASc score, so we underestimate the total thromboembolic risk in AF patients,” he said.
Dr. Hornestam presented a Swedish registry study of 1.36 million patients, including 470,738 patients with new-onset AF and no previous diagnosis of VTE or ischemic stroke and twice as many controls without AF who were matched to the AF patients by age, gender, and county.
The VTE risk was highest during the first 30 days after diagnosis of AF. Women with new-onset AF had an 8.3-fold increased risk of VTE compared with controls during this early period, by a margin of 55.8 versus 6.4 cases per 1,000 person-years. Men with newly diagnosed AF had a 7.2-fold increased risk of VTE in the first 30 days, reflecting a rate of 40.1 per 1,000 person-years compared to 5.6 per 1,000 in controls.
The VTE risk dropped off precipitously in men after the first month. The rate was cut in half by 2 months after AF diagnosis and was no different from that of controls by 9 months.
In women, too, the early elevated VTE risk was halved by 2 months out, but thereafter the rate of decline in VTE risk slowed. Even 10 years after AF diagnosis, women had a 21% greater VTE risk than did matched controls.
Of note, the risk of VTE during the first 12 months after diagnosis of AF was nearly twice as great in both men and women under age 65 than in those older than 75.
These data raise the question of whether standard therapy in AF patients needs to be modified, especially during what now appears to be the critical time frame of the first 3-6 months after diagnosis of the arrhythmia, Dr. Hornestam said.
He reported having no financial conflicts of interest regarding this study.
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: The risk of a first venous thromboembolism is increased 7.2- to 8.3-fold during the first 30 days following diagnosis of AF and remains moderately elevated in women even 10 years later.
Data source: An observational Swedish national registry study of more than 1.3 million patients, including 470,738 with newly diagnosed atrial fibrillation and their matched controls.
Disclosures: The presenter reported having no financial conflicts of interest regarding this study, which was conducted free of commercial support.
Bag-mask ventilation for CPR deflates in large RCT
BARCELONA – Bag-mask ventilation for airway management during resuscitation of patients with out-of-hospital cardiac arrest was considerably less safe and yet no more effective than endotracheal intubation in a large randomized trial, Frederic Adnet, MD, reported at the annual congress of the European Society of Cardiology.
This was an unexpected result.
Several large, well-respected observational registry studies had strongly suggested that bag-mask ventilation is associated with a superior survival rate with good neurologic outcome. As a result, many in the resuscitation science field have been moving closer to replacing endotracheal intubation as the standard of care in favor of bag-mask ventilation. But this first-of-its-kind, large, randomized trial to formally address the issue showed virtually identical rates of day-28 survival with good neurologic outcome in the two study arms. Plus, bag-mask ventilation had a significantly higher complication rate.
“So, at this time, we will not yet change our technique,” according to coinvestigator Eric Vicaut, MD, of Fernand Widal Hospital in Paris.
This major prospective randomized trial included 2,043 patients with out-of-hospital cardiac arrest at 20 centers in France and Belgium. The primary endpoint – day-28 survival with good neurologic status as defined by a Glasgow-Pittsburgh Cerebral Performance Scale score of 2 or less – occurred in 4.2% of the bag-mask ventilation group and 4.1% of the endotracheal intubation group.
However, the rate of aspiration or regurgitation of gastric contents was significantly higher in the bag-mask ventilation group by a margin of 14.9% to 7.7%. Moreover, the bag-mask ventilation technique failed in 6.3% of patients, compared with a 2.5% endotracheal intubation failure rate.
Discussant Susanna Price, MD, praised the study as a high-quality, well-conducted randomized trial, adding that it’s just the sort of study that the field of resuscitation science had needed for a long time. Indeed, most guidelines in the field are based on faint supporting evidence. That may be one reason why good outcomes of out-of-hospital cardiac arrest are so disappointingly low: The worldwide average is roughly 7%, with huge differences between countries.
“It is really very depressing sometimes when one looks at the percentage of patients who actually return to normal life and normal functional neurologic status and, indeed, whose relatives get back to work,” commented Dr. Price, a cardiologist and intensivist at Royal Brompton Hospital in London.
“This is a huge study for resuscitation science,” she continued. “Prehospital airway management is currently a very hot topic. Bear in mind that in the United States, roughly 88% of cardiac arrests happen in the home.”
“This trial does challenge the current feeling that bag-mask ventilation is definitely superior to advanced airway interventions,” Dr. Price added.
For her, the study contained three surprises, she continued. One was the high bag-mask failure rate in the hands of very experienced operators. Another was the high complication rate associated with the device, again even in expert hands. Also, contrary to numerous published reports, the chest compression rate in this RCT was not better with bag mask ventilation.
“The study did not demonstrate that endotracheal intubation interrupts chest compressions. In fact, chest compression pauses were actually significantly more frequent in the bag-mask ventilation group than with endotracheal intubation,” she observed.
It’s worth noting that in the French EMS system, a physician experienced in cardiopulmonary resuscitation is typically on board for ambulance runs. This creates an element of uncertainty as to the generalizability of the study findings to EMS systems where paramedics who may be less proficient in endotracheal intubation are the first responders. Indeed, whether endotracheal intubation will stack up as favorably as it did against bag-mask ventilation in this randomized trial when tested in other settings where airway management is left in the hands of paramedics is an open question that’s the topic of ongoing studies, Dr. Price noted.
Dr. Adnet and Dr. Vicaut reported having no financial conflicts regarding their study, which was funded by the French Ministry of Health.
bjancin@frontlinemedcom.com
BARCELONA – Bag-mask ventilation for airway management during resuscitation of patients with out-of-hospital cardiac arrest was considerably less safe and yet no more effective than endotracheal intubation in a large randomized trial, Frederic Adnet, MD, reported at the annual congress of the European Society of Cardiology.
This was an unexpected result.
Several large, well-respected observational registry studies had strongly suggested that bag-mask ventilation is associated with a superior survival rate with good neurologic outcome. As a result, many in the resuscitation science field have been moving closer to replacing endotracheal intubation as the standard of care in favor of bag-mask ventilation. But this first-of-its-kind, large, randomized trial to formally address the issue showed virtually identical rates of day-28 survival with good neurologic outcome in the two study arms. Plus, bag-mask ventilation had a significantly higher complication rate.
“So, at this time, we will not yet change our technique,” according to coinvestigator Eric Vicaut, MD, of Fernand Widal Hospital in Paris.
This major prospective randomized trial included 2,043 patients with out-of-hospital cardiac arrest at 20 centers in France and Belgium. The primary endpoint – day-28 survival with good neurologic status as defined by a Glasgow-Pittsburgh Cerebral Performance Scale score of 2 or less – occurred in 4.2% of the bag-mask ventilation group and 4.1% of the endotracheal intubation group.
However, the rate of aspiration or regurgitation of gastric contents was significantly higher in the bag-mask ventilation group by a margin of 14.9% to 7.7%. Moreover, the bag-mask ventilation technique failed in 6.3% of patients, compared with a 2.5% endotracheal intubation failure rate.
Discussant Susanna Price, MD, praised the study as a high-quality, well-conducted randomized trial, adding that it’s just the sort of study that the field of resuscitation science had needed for a long time. Indeed, most guidelines in the field are based on faint supporting evidence. That may be one reason why good outcomes of out-of-hospital cardiac arrest are so disappointingly low: The worldwide average is roughly 7%, with huge differences between countries.
“It is really very depressing sometimes when one looks at the percentage of patients who actually return to normal life and normal functional neurologic status and, indeed, whose relatives get back to work,” commented Dr. Price, a cardiologist and intensivist at Royal Brompton Hospital in London.
“This is a huge study for resuscitation science,” she continued. “Prehospital airway management is currently a very hot topic. Bear in mind that in the United States, roughly 88% of cardiac arrests happen in the home.”
“This trial does challenge the current feeling that bag-mask ventilation is definitely superior to advanced airway interventions,” Dr. Price added.
For her, the study contained three surprises, she continued. One was the high bag-mask failure rate in the hands of very experienced operators. Another was the high complication rate associated with the device, again even in expert hands. Also, contrary to numerous published reports, the chest compression rate in this RCT was not better with bag mask ventilation.
“The study did not demonstrate that endotracheal intubation interrupts chest compressions. In fact, chest compression pauses were actually significantly more frequent in the bag-mask ventilation group than with endotracheal intubation,” she observed.
It’s worth noting that in the French EMS system, a physician experienced in cardiopulmonary resuscitation is typically on board for ambulance runs. This creates an element of uncertainty as to the generalizability of the study findings to EMS systems where paramedics who may be less proficient in endotracheal intubation are the first responders. Indeed, whether endotracheal intubation will stack up as favorably as it did against bag-mask ventilation in this randomized trial when tested in other settings where airway management is left in the hands of paramedics is an open question that’s the topic of ongoing studies, Dr. Price noted.
Dr. Adnet and Dr. Vicaut reported having no financial conflicts regarding their study, which was funded by the French Ministry of Health.
bjancin@frontlinemedcom.com
BARCELONA – Bag-mask ventilation for airway management during resuscitation of patients with out-of-hospital cardiac arrest was considerably less safe and yet no more effective than endotracheal intubation in a large randomized trial, Frederic Adnet, MD, reported at the annual congress of the European Society of Cardiology.
This was an unexpected result.
Several large, well-respected observational registry studies had strongly suggested that bag-mask ventilation is associated with a superior survival rate with good neurologic outcome. As a result, many in the resuscitation science field have been moving closer to replacing endotracheal intubation as the standard of care in favor of bag-mask ventilation. But this first-of-its-kind, large, randomized trial to formally address the issue showed virtually identical rates of day-28 survival with good neurologic outcome in the two study arms. Plus, bag-mask ventilation had a significantly higher complication rate.
“So, at this time, we will not yet change our technique,” according to coinvestigator Eric Vicaut, MD, of Fernand Widal Hospital in Paris.
This major prospective randomized trial included 2,043 patients with out-of-hospital cardiac arrest at 20 centers in France and Belgium. The primary endpoint – day-28 survival with good neurologic status as defined by a Glasgow-Pittsburgh Cerebral Performance Scale score of 2 or less – occurred in 4.2% of the bag-mask ventilation group and 4.1% of the endotracheal intubation group.
However, the rate of aspiration or regurgitation of gastric contents was significantly higher in the bag-mask ventilation group by a margin of 14.9% to 7.7%. Moreover, the bag-mask ventilation technique failed in 6.3% of patients, compared with a 2.5% endotracheal intubation failure rate.
Discussant Susanna Price, MD, praised the study as a high-quality, well-conducted randomized trial, adding that it’s just the sort of study that the field of resuscitation science had needed for a long time. Indeed, most guidelines in the field are based on faint supporting evidence. That may be one reason why good outcomes of out-of-hospital cardiac arrest are so disappointingly low: The worldwide average is roughly 7%, with huge differences between countries.
“It is really very depressing sometimes when one looks at the percentage of patients who actually return to normal life and normal functional neurologic status and, indeed, whose relatives get back to work,” commented Dr. Price, a cardiologist and intensivist at Royal Brompton Hospital in London.
“This is a huge study for resuscitation science,” she continued. “Prehospital airway management is currently a very hot topic. Bear in mind that in the United States, roughly 88% of cardiac arrests happen in the home.”
“This trial does challenge the current feeling that bag-mask ventilation is definitely superior to advanced airway interventions,” Dr. Price added.
For her, the study contained three surprises, she continued. One was the high bag-mask failure rate in the hands of very experienced operators. Another was the high complication rate associated with the device, again even in expert hands. Also, contrary to numerous published reports, the chest compression rate in this RCT was not better with bag mask ventilation.
“The study did not demonstrate that endotracheal intubation interrupts chest compressions. In fact, chest compression pauses were actually significantly more frequent in the bag-mask ventilation group than with endotracheal intubation,” she observed.
It’s worth noting that in the French EMS system, a physician experienced in cardiopulmonary resuscitation is typically on board for ambulance runs. This creates an element of uncertainty as to the generalizability of the study findings to EMS systems where paramedics who may be less proficient in endotracheal intubation are the first responders. Indeed, whether endotracheal intubation will stack up as favorably as it did against bag-mask ventilation in this randomized trial when tested in other settings where airway management is left in the hands of paramedics is an open question that’s the topic of ongoing studies, Dr. Price noted.
Dr. Adnet and Dr. Vicaut reported having no financial conflicts regarding their study, which was funded by the French Ministry of Health.
bjancin@frontlinemedcom.com
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: Rates of survival with good neurologic outcome 28 days after out-of-hospital cardiac arrest were similarly low whether airway management during CPR relied upon endotracheal intubation or bag-mask ventilation, but the latter strategy had a significantly higher complication rate.
Data source: This prospective randomized trial included 2,043 patients with out-of-hospital cardiac arrest at 20 centers in France and Belgium.
Disclosures: The study was funded by the French Ministry of Health. The presenter reported having no financial conflicts.
Rethinking lithium: It keeps patients with unipolar depression out of the hospital
PARIS – What’s the most effective medication for preventing rehospitalization in patients previously admitted for severe unipolar depression?
The answer, based upon a study of all 123,712 patients hospitalized for severe unipolar depression in Finland during 1987-2012, might come as a surprise. The medication that most effectively kept patients from returning to the hospital wasn’t a selective serotonin reuptake inhibitor (SSRI), a serotonin-norepinephrine reuptake inhibitor (SNRI), or an atypical antipsychotic. It was lithium, Markku Lahteenvuo, MD, reported at the annual congress of the European College of Neuropsychopharmacology.
Using comprehensive nationwide databases, he and his coinvestigators followed these 123,712 hospitalized patients for a mean of 7.9 years, during which 49,146 of them had a total of 153,784 rehospitalizations for mental disorders. The investigators analyzed what psychotropic drugs the patients were taking when rehospitalized, as well as the drugs they were taking when they were out of hospital. Individuals served as their own controls in order to eliminate selection bias.
In an analysis adjusted for time since diagnosis of unipolar depression, the temporal order of prescribed drugs, and other concomitant medications, the use of lithium was associated with a 53% reduction in the risk of readmission, compared with nonuse.
Patients using lithium as monotherapy for their depression were 69% less likely to be rehospitalized than if they were not, whereas patients on lithium with antidepressants had a more modest 50% reduction in rehospitalization risk, reported Dr. Lahteenvuo, a forensic psychiatrist at Niuvanniemi Hospital and the University of Eastern Finland in Kuopio.
After lithium, clozapine was the drug associated with the next lowest risk of rehospitalization for a mental disorder. Patients on that drug were 35% less likely to be rehospitalized; however, clozapine wasn’t widely prescribed in patients with severe unipolar depression.
Antidepressants as a broad class were associated with a statistically significant 10% increase in risk of rehospitalization for a mental disorder. But within that category there were a couple of exceptions: Amitriptyline, which was widely prescribed, particularly in the early years of the study period, was associated with a 25% reduction in rehospitalization, compared with no use. And doxepin was associated with a 15% reduction.
Antipsychotics were associated with an overall 16% increased risk of rehospitalization, compared with no use. But there were some notable exceptions within this class of drugs. Both quetiapine and aripiprazole were associated with an 18% risk reduction.
The investigators also analyzed all-cause rehospitalizations, including acute myocardial infarction and all other somatic diseases, as well as mental disorders. During follow-up, 98,662 patients who had been hospitalized for severe unipolar depression had a collective total of 592,926 all-cause rehospitalizations.
Dr. Lahteenvuo said he had expected that lithium’s strong showing in preventing psychiatric rehospitalization might be offset by an increased risk of hospitalization for other conditions, because of the drug’s well-established association with thyroid, renal, and other toxicities. But that was not the case. Patients on lithium without antidepressants were 49% less likely to have an all-cause hospitalization than when they were not using the drug, and patients on lithium with antidepressants had a 42% reduction in risk.
”It seems that lithium also shielded the patients from going to the hospital for any somatic reason. So lithium seems to be safe and prevents various somatic hospitalizations as well. Whether that’s due to the drug’s enhancement of your ability to live your life, eat healthy, exercise, and give you energy to have good lifestyle habits, or it actually has an anti-inflammatory effect or other disease-modifying effect, we do not know,” Dr. Lahteenvuo said.
Lithium has traditionally been prescribed mainly as third-line therapy in treatment-refractory patients for severe unipolar depression. The Finnish data suggest it’s time to reconsider that strategy.
“We think lithium should be considered for a wider audience, keeping in mind of course that it can cause thyroid and kidney toxicity,” Dr. Lahteenvuo said.
Patients taking clozapine were 30% less likely to have an all-cause hospitalization than nonusers. Aripiprazole was associated with a 21% reduction in risk, quetiapine had a 12% risk reduction, amitriptyline had an 11% risk reduction, and doxepin had a 12% risk reduction.
In contrast, all-cause hospitalization was 12% more likely when patients were taking chronic benzodiazepines and 8% more likely while on hypnotics.
The full study results were published in the Lancet Psychiatry (2017 Jul;4[7]:547-53).
Dr. Lahteenvuo reported having no financial conflicts of interest related to the study, which was funded by the Finnish Ministry of Health.
PARIS – What’s the most effective medication for preventing rehospitalization in patients previously admitted for severe unipolar depression?
The answer, based upon a study of all 123,712 patients hospitalized for severe unipolar depression in Finland during 1987-2012, might come as a surprise. The medication that most effectively kept patients from returning to the hospital wasn’t a selective serotonin reuptake inhibitor (SSRI), a serotonin-norepinephrine reuptake inhibitor (SNRI), or an atypical antipsychotic. It was lithium, Markku Lahteenvuo, MD, reported at the annual congress of the European College of Neuropsychopharmacology.
Using comprehensive nationwide databases, he and his coinvestigators followed these 123,712 hospitalized patients for a mean of 7.9 years, during which 49,146 of them had a total of 153,784 rehospitalizations for mental disorders. The investigators analyzed what psychotropic drugs the patients were taking when rehospitalized, as well as the drugs they were taking when they were out of hospital. Individuals served as their own controls in order to eliminate selection bias.
In an analysis adjusted for time since diagnosis of unipolar depression, the temporal order of prescribed drugs, and other concomitant medications, the use of lithium was associated with a 53% reduction in the risk of readmission, compared with nonuse.
Patients using lithium as monotherapy for their depression were 69% less likely to be rehospitalized than if they were not, whereas patients on lithium with antidepressants had a more modest 50% reduction in rehospitalization risk, reported Dr. Lahteenvuo, a forensic psychiatrist at Niuvanniemi Hospital and the University of Eastern Finland in Kuopio.
After lithium, clozapine was the drug associated with the next lowest risk of rehospitalization for a mental disorder. Patients on that drug were 35% less likely to be rehospitalized; however, clozapine wasn’t widely prescribed in patients with severe unipolar depression.
Antidepressants as a broad class were associated with a statistically significant 10% increase in risk of rehospitalization for a mental disorder. But within that category there were a couple of exceptions: Amitriptyline, which was widely prescribed, particularly in the early years of the study period, was associated with a 25% reduction in rehospitalization, compared with no use. And doxepin was associated with a 15% reduction.
Antipsychotics were associated with an overall 16% increased risk of rehospitalization, compared with no use. But there were some notable exceptions within this class of drugs. Both quetiapine and aripiprazole were associated with an 18% risk reduction.
The investigators also analyzed all-cause rehospitalizations, including acute myocardial infarction and all other somatic diseases, as well as mental disorders. During follow-up, 98,662 patients who had been hospitalized for severe unipolar depression had a collective total of 592,926 all-cause rehospitalizations.
Dr. Lahteenvuo said he had expected that lithium’s strong showing in preventing psychiatric rehospitalization might be offset by an increased risk of hospitalization for other conditions, because of the drug’s well-established association with thyroid, renal, and other toxicities. But that was not the case. Patients on lithium without antidepressants were 49% less likely to have an all-cause hospitalization than when they were not using the drug, and patients on lithium with antidepressants had a 42% reduction in risk.
”It seems that lithium also shielded the patients from going to the hospital for any somatic reason. So lithium seems to be safe and prevents various somatic hospitalizations as well. Whether that’s due to the drug’s enhancement of your ability to live your life, eat healthy, exercise, and give you energy to have good lifestyle habits, or it actually has an anti-inflammatory effect or other disease-modifying effect, we do not know,” Dr. Lahteenvuo said.
Lithium has traditionally been prescribed mainly as third-line therapy in treatment-refractory patients for severe unipolar depression. The Finnish data suggest it’s time to reconsider that strategy.
“We think lithium should be considered for a wider audience, keeping in mind of course that it can cause thyroid and kidney toxicity,” Dr. Lahteenvuo said.
Patients taking clozapine were 30% less likely to have an all-cause hospitalization than nonusers. Aripiprazole was associated with a 21% reduction in risk, quetiapine had a 12% risk reduction, amitriptyline had an 11% risk reduction, and doxepin had a 12% risk reduction.
In contrast, all-cause hospitalization was 12% more likely when patients were taking chronic benzodiazepines and 8% more likely while on hypnotics.
The full study results were published in the Lancet Psychiatry (2017 Jul;4[7]:547-53).
Dr. Lahteenvuo reported having no financial conflicts of interest related to the study, which was funded by the Finnish Ministry of Health.
PARIS – What’s the most effective medication for preventing rehospitalization in patients previously admitted for severe unipolar depression?
The answer, based upon a study of all 123,712 patients hospitalized for severe unipolar depression in Finland during 1987-2012, might come as a surprise. The medication that most effectively kept patients from returning to the hospital wasn’t a selective serotonin reuptake inhibitor (SSRI), a serotonin-norepinephrine reuptake inhibitor (SNRI), or an atypical antipsychotic. It was lithium, Markku Lahteenvuo, MD, reported at the annual congress of the European College of Neuropsychopharmacology.
Using comprehensive nationwide databases, he and his coinvestigators followed these 123,712 hospitalized patients for a mean of 7.9 years, during which 49,146 of them had a total of 153,784 rehospitalizations for mental disorders. The investigators analyzed what psychotropic drugs the patients were taking when rehospitalized, as well as the drugs they were taking when they were out of hospital. Individuals served as their own controls in order to eliminate selection bias.
In an analysis adjusted for time since diagnosis of unipolar depression, the temporal order of prescribed drugs, and other concomitant medications, the use of lithium was associated with a 53% reduction in the risk of readmission, compared with nonuse.
Patients using lithium as monotherapy for their depression were 69% less likely to be rehospitalized than if they were not, whereas patients on lithium with antidepressants had a more modest 50% reduction in rehospitalization risk, reported Dr. Lahteenvuo, a forensic psychiatrist at Niuvanniemi Hospital and the University of Eastern Finland in Kuopio.
After lithium, clozapine was the drug associated with the next lowest risk of rehospitalization for a mental disorder. Patients on that drug were 35% less likely to be rehospitalized; however, clozapine wasn’t widely prescribed in patients with severe unipolar depression.
Antidepressants as a broad class were associated with a statistically significant 10% increase in risk of rehospitalization for a mental disorder. But within that category there were a couple of exceptions: Amitriptyline, which was widely prescribed, particularly in the early years of the study period, was associated with a 25% reduction in rehospitalization, compared with no use. And doxepin was associated with a 15% reduction.
Antipsychotics were associated with an overall 16% increased risk of rehospitalization, compared with no use. But there were some notable exceptions within this class of drugs. Both quetiapine and aripiprazole were associated with an 18% risk reduction.
The investigators also analyzed all-cause rehospitalizations, including acute myocardial infarction and all other somatic diseases, as well as mental disorders. During follow-up, 98,662 patients who had been hospitalized for severe unipolar depression had a collective total of 592,926 all-cause rehospitalizations.
Dr. Lahteenvuo said he had expected that lithium’s strong showing in preventing psychiatric rehospitalization might be offset by an increased risk of hospitalization for other conditions, because of the drug’s well-established association with thyroid, renal, and other toxicities. But that was not the case. Patients on lithium without antidepressants were 49% less likely to have an all-cause hospitalization than when they were not using the drug, and patients on lithium with antidepressants had a 42% reduction in risk.
”It seems that lithium also shielded the patients from going to the hospital for any somatic reason. So lithium seems to be safe and prevents various somatic hospitalizations as well. Whether that’s due to the drug’s enhancement of your ability to live your life, eat healthy, exercise, and give you energy to have good lifestyle habits, or it actually has an anti-inflammatory effect or other disease-modifying effect, we do not know,” Dr. Lahteenvuo said.
Lithium has traditionally been prescribed mainly as third-line therapy in treatment-refractory patients for severe unipolar depression. The Finnish data suggest it’s time to reconsider that strategy.
“We think lithium should be considered for a wider audience, keeping in mind of course that it can cause thyroid and kidney toxicity,” Dr. Lahteenvuo said.
Patients taking clozapine were 30% less likely to have an all-cause hospitalization than nonusers. Aripiprazole was associated with a 21% reduction in risk, quetiapine had a 12% risk reduction, amitriptyline had an 11% risk reduction, and doxepin had a 12% risk reduction.
In contrast, all-cause hospitalization was 12% more likely when patients were taking chronic benzodiazepines and 8% more likely while on hypnotics.
The full study results were published in the Lancet Psychiatry (2017 Jul;4[7]:547-53).
Dr. Lahteenvuo reported having no financial conflicts of interest related to the study, which was funded by the Finnish Ministry of Health.
AT THE ECNP CONGRESS
Key clinical point:
Major finding: Patients on lithium alone were 69% less likely to be rehospitalized for a mental disorder than nonusers.
Data source: This cohort study included all 123,712 Finnish patients who were hospitalized for severe unipolar depression during 1987-2012, along with rehospitalizations during a mean 7.9 years of follow-up.
Disclosures: The study was funded by the Finnish Ministry of Health. The presenter reported having no financial conflicts.
Lumateperone shows broad phase 3 potential for psychiatric disorders
PARIS – including Alzheimer’s disease, on the strength of strong performances in phase 2 studies, Cedric O’Gorman, MD, reported at the annual congress of the European College of Neuropsychopharmacology.
The drug acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems, providing a unique mechanism of action well-suited for treatment of a range of neuropsychiatric disorders, observed Dr. O’Gorman, who was vice president of medical affairs at the drug’s developer, Intra-Cellular Therapies during the ECNP congress and is now senior vice president for clinical development and medical affairs at Axsome Therapeutics in New York.
At lower doses, lumateperone is a potent serotonin 5-HT2A receptor antagonist that shows promise as a treatment for primary insomnia as well as agitation and aggression in elderly patients with dementia. As the dose increases, lumateperone also serves as a mesolimbic and mesocortical dopamine receptor phosphoprotein modulator with dual properties, acting at the level of the dopamine D2 receptor both as a presynaptic partial agonist and a postsynaptic antagonist.
The drug also enhances NMDA- and AMPA-induced currents in medial prefrontal cortex pyramidal neurons via activation of the D1 receptor. These attributes provide antipsychotic and antidepressant efficacy.
Positron emission tomography studies in patients with schizophrenia have shown that lumateperone at 60 mg once daily effectively reduced psychosis symptoms at roughly 40% striatal D2 receptor occupancy, which is much lower than the occupancy level required by approved antipsychotic drugs. This attribute, coupled with the drug’s potent effects on serotonin 5-HT2A receptors, serotonin transporters, and D1 receptors, probably accounts for lumateperone’s antipsychotic efficacy and accompanying improved psychosocial function and minimal motor disturbances as demonstrated in the clinical trials, according to Dr. O’Gorman.
The two randomized, double-blind, multicenter, placebo-controlled phase 3 trials in schizophrenia totaled 1,146 patients. The trials included an arm in which patients were randomized to risperidone (Risperdal) at 4 mg/day. The lumateperone and risperidone groups showed similar improvement as measured by the Positive and Negative Syndrome Scale score.
However, lumateperone had a better safety profile, with significantly less weight gain than in the risperidone group. Moreover, lumateperone-treated patients didn’t experience the adverse changes in blood glucose, triglycerides, total cholesterol, and prolactin observed in the risperidone group.
The safety profile of lumateperone as documented in the various clinical trials to date is similar to placebo, Dr. O’Gorman reported.
PARIS – including Alzheimer’s disease, on the strength of strong performances in phase 2 studies, Cedric O’Gorman, MD, reported at the annual congress of the European College of Neuropsychopharmacology.
The drug acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems, providing a unique mechanism of action well-suited for treatment of a range of neuropsychiatric disorders, observed Dr. O’Gorman, who was vice president of medical affairs at the drug’s developer, Intra-Cellular Therapies during the ECNP congress and is now senior vice president for clinical development and medical affairs at Axsome Therapeutics in New York.
At lower doses, lumateperone is a potent serotonin 5-HT2A receptor antagonist that shows promise as a treatment for primary insomnia as well as agitation and aggression in elderly patients with dementia. As the dose increases, lumateperone also serves as a mesolimbic and mesocortical dopamine receptor phosphoprotein modulator with dual properties, acting at the level of the dopamine D2 receptor both as a presynaptic partial agonist and a postsynaptic antagonist.
The drug also enhances NMDA- and AMPA-induced currents in medial prefrontal cortex pyramidal neurons via activation of the D1 receptor. These attributes provide antipsychotic and antidepressant efficacy.
Positron emission tomography studies in patients with schizophrenia have shown that lumateperone at 60 mg once daily effectively reduced psychosis symptoms at roughly 40% striatal D2 receptor occupancy, which is much lower than the occupancy level required by approved antipsychotic drugs. This attribute, coupled with the drug’s potent effects on serotonin 5-HT2A receptors, serotonin transporters, and D1 receptors, probably accounts for lumateperone’s antipsychotic efficacy and accompanying improved psychosocial function and minimal motor disturbances as demonstrated in the clinical trials, according to Dr. O’Gorman.
The two randomized, double-blind, multicenter, placebo-controlled phase 3 trials in schizophrenia totaled 1,146 patients. The trials included an arm in which patients were randomized to risperidone (Risperdal) at 4 mg/day. The lumateperone and risperidone groups showed similar improvement as measured by the Positive and Negative Syndrome Scale score.
However, lumateperone had a better safety profile, with significantly less weight gain than in the risperidone group. Moreover, lumateperone-treated patients didn’t experience the adverse changes in blood glucose, triglycerides, total cholesterol, and prolactin observed in the risperidone group.
The safety profile of lumateperone as documented in the various clinical trials to date is similar to placebo, Dr. O’Gorman reported.
PARIS – including Alzheimer’s disease, on the strength of strong performances in phase 2 studies, Cedric O’Gorman, MD, reported at the annual congress of the European College of Neuropsychopharmacology.
The drug acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems, providing a unique mechanism of action well-suited for treatment of a range of neuropsychiatric disorders, observed Dr. O’Gorman, who was vice president of medical affairs at the drug’s developer, Intra-Cellular Therapies during the ECNP congress and is now senior vice president for clinical development and medical affairs at Axsome Therapeutics in New York.
At lower doses, lumateperone is a potent serotonin 5-HT2A receptor antagonist that shows promise as a treatment for primary insomnia as well as agitation and aggression in elderly patients with dementia. As the dose increases, lumateperone also serves as a mesolimbic and mesocortical dopamine receptor phosphoprotein modulator with dual properties, acting at the level of the dopamine D2 receptor both as a presynaptic partial agonist and a postsynaptic antagonist.
The drug also enhances NMDA- and AMPA-induced currents in medial prefrontal cortex pyramidal neurons via activation of the D1 receptor. These attributes provide antipsychotic and antidepressant efficacy.
Positron emission tomography studies in patients with schizophrenia have shown that lumateperone at 60 mg once daily effectively reduced psychosis symptoms at roughly 40% striatal D2 receptor occupancy, which is much lower than the occupancy level required by approved antipsychotic drugs. This attribute, coupled with the drug’s potent effects on serotonin 5-HT2A receptors, serotonin transporters, and D1 receptors, probably accounts for lumateperone’s antipsychotic efficacy and accompanying improved psychosocial function and minimal motor disturbances as demonstrated in the clinical trials, according to Dr. O’Gorman.
The two randomized, double-blind, multicenter, placebo-controlled phase 3 trials in schizophrenia totaled 1,146 patients. The trials included an arm in which patients were randomized to risperidone (Risperdal) at 4 mg/day. The lumateperone and risperidone groups showed similar improvement as measured by the Positive and Negative Syndrome Scale score.
However, lumateperone had a better safety profile, with significantly less weight gain than in the risperidone group. Moreover, lumateperone-treated patients didn’t experience the adverse changes in blood glucose, triglycerides, total cholesterol, and prolactin observed in the risperidone group.
The safety profile of lumateperone as documented in the various clinical trials to date is similar to placebo, Dr. O’Gorman reported.
EXPERT ANALYSIS FROM THE ECNP CONGRESS
Psoriasis patients face higher risk of alcohol-related death – but lower suicide risk
GENEVA – Psoriasis patients are roughly two-thirds more likely to die of alcohol-related causes than their peers in the general population, Rosa Parisi, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.
Indeed, alcohol-related mortality appears to be an important contributor to the long-recognized elevated risk of premature mortality in patients who’ve been diagnosed with psoriasis, according to Dr. Parisi of the University of Manchester (England), who presented the results of a retrospective cohort study of alcohol-related deaths. The reasons for psoriasis patients’ increased risk of early mortality have been unclear, although it’s well established that psoriasis is associated with increased rates of unhealthy behaviors, including smoking and high alcohol consumption.
The study of alcohol-related deaths utilized a database of 398 primary care practices in England. The study population consisted of 55,537 patients diagnosed with psoriasis in 1998-2014 and 854,314 controls without psoriasis who were matched based on age, sex, and membership in the same primary care practice.
During a median 4.4 years of follow-up, the rate of deaths directly attributable to alcohol consumption was 4.8 per 10,000 person-years in the psoriasis group and 2.5 per 10,000 person-years in controls. Nearly two-thirds of the alcohol-related deaths were recorded as due to alcoholic liver disease and 24% to hepatic fibrosis and cirrhosis; 8% were attributed to mental and behavioral disorders due to alcohol.
In an analysis adjusted for socioeconomic status, the risk for alcohol-related death was increased 1.58-fold in the psoriasis group, compared with controls. Upon exclusion of all subjects who’d been on methotrexate on the grounds that the drug interacts with alcohol to accelerate liver damage, having psoriasis was associated with a 1.66-fold increased risk of alcohol-related death.
Such deaths occurred in women with psoriasis at a median age of 55 – a full 5 years younger than alcohol-related deaths in nonpsoriatic women. The age gap was smaller in men.
Medical records indicated that 82.2% of psoriasis patients who died of alcohol-related causes had previously been coded by their primary care practitioner as a heavy drinker, as were 75.5% of those without psoriasis who died of similar causes. Yet fewer than 11% of the psoriasis patients and controls who experienced alcohol-related mortality had ever received a prescription for a medication for alcohol dependence, such as disulfiram. Psychologic support for alcohol dependence had been offered within the primary care practices for only 19.7% of psoriasis patients with an alcohol-related death and 14.4% of controls.
These statistics contain an important message for clinicians, Dr. Parisi said.
“Alcohol misuse often remains unidentified and undertreated in primary care. Health care practitioners should be more aware of the psychologic difficulties of people with psoriasis. The Alcohol Use Disorders Identification Test screening tool, which has been developed by the World Health Organization, should be implemented in both primary and secondary care to detect alcohol misuse in psoriasis patients,” she asserted.
Elsewhere at the meeting, she presented a study on the risks of suicide and nonfatal deliberate self-harm among psoriasis patients. She utilized the same database of 398 English primary care medical practices. This analysis included 56,961 psoriasis patients and 876,919 matched controls.
The suicide rate was 1.1 per 10,000 person-years in the psoriasis group and 1.5 per 10,000 person-years in controls. In a proportional hazard analysis adjusted for socioeconomic status, psoriasis patients were at a significant 41% lower risk of suicide than their nonpsoriatic peers. Breaking down the data further based upon age at diagnosis of psoriasis, patients diagnosed before age 40 were at a nonsignificant 8% lower risk of suicide, while those diagnosed at age 40 years or older experienced a highly significant 62% reduction in risk of suicide, compared with controls.
This was the case even though the psoriasis group had a significantly greater prevalence of psychiatric comorbidities overall, by a margin of 29.2% versus 26.4%.
The analysis of risk of nonfatal deliberate self-harm was done after excluding all individuals in the suicide study who had a baseline history of self-harm. This resulted in a study population of 54,709 psoriasis patients and 813,699 controls matched by age, sex, and primary care practice. Bottom line: There was no evidence of an association between having a diagnosis of psoriasis and nonfatal deliberate self-harm. The rates – 18.9 events per 10,000 person-years in the psoriasis group and 16.3 per 10,000 person-years in controls – were closely similar after adjusting for socioeconomic status.
Simultaneous with her EADV presentation on alcohol-related deaths in psoriasis patients, Dr. Parisi’s study was published online (JAMA Dermatol. 2017 Sep 15. doi: 10.1001/jamadermatol.2017.3225).
She reported having no financial conflicts of interest regarding her presentations.
GENEVA – Psoriasis patients are roughly two-thirds more likely to die of alcohol-related causes than their peers in the general population, Rosa Parisi, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.
Indeed, alcohol-related mortality appears to be an important contributor to the long-recognized elevated risk of premature mortality in patients who’ve been diagnosed with psoriasis, according to Dr. Parisi of the University of Manchester (England), who presented the results of a retrospective cohort study of alcohol-related deaths. The reasons for psoriasis patients’ increased risk of early mortality have been unclear, although it’s well established that psoriasis is associated with increased rates of unhealthy behaviors, including smoking and high alcohol consumption.
The study of alcohol-related deaths utilized a database of 398 primary care practices in England. The study population consisted of 55,537 patients diagnosed with psoriasis in 1998-2014 and 854,314 controls without psoriasis who were matched based on age, sex, and membership in the same primary care practice.
During a median 4.4 years of follow-up, the rate of deaths directly attributable to alcohol consumption was 4.8 per 10,000 person-years in the psoriasis group and 2.5 per 10,000 person-years in controls. Nearly two-thirds of the alcohol-related deaths were recorded as due to alcoholic liver disease and 24% to hepatic fibrosis and cirrhosis; 8% were attributed to mental and behavioral disorders due to alcohol.
In an analysis adjusted for socioeconomic status, the risk for alcohol-related death was increased 1.58-fold in the psoriasis group, compared with controls. Upon exclusion of all subjects who’d been on methotrexate on the grounds that the drug interacts with alcohol to accelerate liver damage, having psoriasis was associated with a 1.66-fold increased risk of alcohol-related death.
Such deaths occurred in women with psoriasis at a median age of 55 – a full 5 years younger than alcohol-related deaths in nonpsoriatic women. The age gap was smaller in men.
Medical records indicated that 82.2% of psoriasis patients who died of alcohol-related causes had previously been coded by their primary care practitioner as a heavy drinker, as were 75.5% of those without psoriasis who died of similar causes. Yet fewer than 11% of the psoriasis patients and controls who experienced alcohol-related mortality had ever received a prescription for a medication for alcohol dependence, such as disulfiram. Psychologic support for alcohol dependence had been offered within the primary care practices for only 19.7% of psoriasis patients with an alcohol-related death and 14.4% of controls.
These statistics contain an important message for clinicians, Dr. Parisi said.
“Alcohol misuse often remains unidentified and undertreated in primary care. Health care practitioners should be more aware of the psychologic difficulties of people with psoriasis. The Alcohol Use Disorders Identification Test screening tool, which has been developed by the World Health Organization, should be implemented in both primary and secondary care to detect alcohol misuse in psoriasis patients,” she asserted.
Elsewhere at the meeting, she presented a study on the risks of suicide and nonfatal deliberate self-harm among psoriasis patients. She utilized the same database of 398 English primary care medical practices. This analysis included 56,961 psoriasis patients and 876,919 matched controls.
The suicide rate was 1.1 per 10,000 person-years in the psoriasis group and 1.5 per 10,000 person-years in controls. In a proportional hazard analysis adjusted for socioeconomic status, psoriasis patients were at a significant 41% lower risk of suicide than their nonpsoriatic peers. Breaking down the data further based upon age at diagnosis of psoriasis, patients diagnosed before age 40 were at a nonsignificant 8% lower risk of suicide, while those diagnosed at age 40 years or older experienced a highly significant 62% reduction in risk of suicide, compared with controls.
This was the case even though the psoriasis group had a significantly greater prevalence of psychiatric comorbidities overall, by a margin of 29.2% versus 26.4%.
The analysis of risk of nonfatal deliberate self-harm was done after excluding all individuals in the suicide study who had a baseline history of self-harm. This resulted in a study population of 54,709 psoriasis patients and 813,699 controls matched by age, sex, and primary care practice. Bottom line: There was no evidence of an association between having a diagnosis of psoriasis and nonfatal deliberate self-harm. The rates – 18.9 events per 10,000 person-years in the psoriasis group and 16.3 per 10,000 person-years in controls – were closely similar after adjusting for socioeconomic status.
Simultaneous with her EADV presentation on alcohol-related deaths in psoriasis patients, Dr. Parisi’s study was published online (JAMA Dermatol. 2017 Sep 15. doi: 10.1001/jamadermatol.2017.3225).
She reported having no financial conflicts of interest regarding her presentations.
GENEVA – Psoriasis patients are roughly two-thirds more likely to die of alcohol-related causes than their peers in the general population, Rosa Parisi, PhD, reported at the annual congress of the European Academy of Dermatology and Venereology.
Indeed, alcohol-related mortality appears to be an important contributor to the long-recognized elevated risk of premature mortality in patients who’ve been diagnosed with psoriasis, according to Dr. Parisi of the University of Manchester (England), who presented the results of a retrospective cohort study of alcohol-related deaths. The reasons for psoriasis patients’ increased risk of early mortality have been unclear, although it’s well established that psoriasis is associated with increased rates of unhealthy behaviors, including smoking and high alcohol consumption.
The study of alcohol-related deaths utilized a database of 398 primary care practices in England. The study population consisted of 55,537 patients diagnosed with psoriasis in 1998-2014 and 854,314 controls without psoriasis who were matched based on age, sex, and membership in the same primary care practice.
During a median 4.4 years of follow-up, the rate of deaths directly attributable to alcohol consumption was 4.8 per 10,000 person-years in the psoriasis group and 2.5 per 10,000 person-years in controls. Nearly two-thirds of the alcohol-related deaths were recorded as due to alcoholic liver disease and 24% to hepatic fibrosis and cirrhosis; 8% were attributed to mental and behavioral disorders due to alcohol.
In an analysis adjusted for socioeconomic status, the risk for alcohol-related death was increased 1.58-fold in the psoriasis group, compared with controls. Upon exclusion of all subjects who’d been on methotrexate on the grounds that the drug interacts with alcohol to accelerate liver damage, having psoriasis was associated with a 1.66-fold increased risk of alcohol-related death.
Such deaths occurred in women with psoriasis at a median age of 55 – a full 5 years younger than alcohol-related deaths in nonpsoriatic women. The age gap was smaller in men.
Medical records indicated that 82.2% of psoriasis patients who died of alcohol-related causes had previously been coded by their primary care practitioner as a heavy drinker, as were 75.5% of those without psoriasis who died of similar causes. Yet fewer than 11% of the psoriasis patients and controls who experienced alcohol-related mortality had ever received a prescription for a medication for alcohol dependence, such as disulfiram. Psychologic support for alcohol dependence had been offered within the primary care practices for only 19.7% of psoriasis patients with an alcohol-related death and 14.4% of controls.
These statistics contain an important message for clinicians, Dr. Parisi said.
“Alcohol misuse often remains unidentified and undertreated in primary care. Health care practitioners should be more aware of the psychologic difficulties of people with psoriasis. The Alcohol Use Disorders Identification Test screening tool, which has been developed by the World Health Organization, should be implemented in both primary and secondary care to detect alcohol misuse in psoriasis patients,” she asserted.
Elsewhere at the meeting, she presented a study on the risks of suicide and nonfatal deliberate self-harm among psoriasis patients. She utilized the same database of 398 English primary care medical practices. This analysis included 56,961 psoriasis patients and 876,919 matched controls.
The suicide rate was 1.1 per 10,000 person-years in the psoriasis group and 1.5 per 10,000 person-years in controls. In a proportional hazard analysis adjusted for socioeconomic status, psoriasis patients were at a significant 41% lower risk of suicide than their nonpsoriatic peers. Breaking down the data further based upon age at diagnosis of psoriasis, patients diagnosed before age 40 were at a nonsignificant 8% lower risk of suicide, while those diagnosed at age 40 years or older experienced a highly significant 62% reduction in risk of suicide, compared with controls.
This was the case even though the psoriasis group had a significantly greater prevalence of psychiatric comorbidities overall, by a margin of 29.2% versus 26.4%.
The analysis of risk of nonfatal deliberate self-harm was done after excluding all individuals in the suicide study who had a baseline history of self-harm. This resulted in a study population of 54,709 psoriasis patients and 813,699 controls matched by age, sex, and primary care practice. Bottom line: There was no evidence of an association between having a diagnosis of psoriasis and nonfatal deliberate self-harm. The rates – 18.9 events per 10,000 person-years in the psoriasis group and 16.3 per 10,000 person-years in controls – were closely similar after adjusting for socioeconomic status.
Simultaneous with her EADV presentation on alcohol-related deaths in psoriasis patients, Dr. Parisi’s study was published online (JAMA Dermatol. 2017 Sep 15. doi: 10.1001/jamadermatol.2017.3225).
She reported having no financial conflicts of interest regarding her presentations.
AT THE EADV CONGRESS
Key clinical point:
Major finding: Psoriasis patients who had never been on methotrexate had a 66% higher rate of alcohol-related death than matched controls without psoriasis.
Data source: This retrospective cohort study of alcohol-related deaths included 55,537 psoriasis patients and 854,314 controls without psoriasis matched based on age, sex, and membership in the same primary care practice.
Disclosures: The study presenter reported having no financial conflicts of interest.
AF patients without oral anticoagulation face higher dementia risk
BARCELONA – The risk of developing dementia was reduced by 48% in patients with atrial fibrillation who were adherent to oral anticoagulation compared with those who were not, according to a Swedish propensity-matched registry study involving nearly 162,000 patients with the arrhythmia.
The study also addressed whether patients with atrial fibrillation (AF) are better off in terms of reducing their dementia risk if they’re on warfarin versus one of the novel oral anticoagulants. The answer is that it makes absolutely no difference, Leif Friberg, MD, reported at the annual congress of the European Society of Cardiology.
“We found no difference whatsoever in any of the subgroups. It appears that it is more important that you have some kind of oral treatment than exactly what kind to have,” said Dr. Friberg, a cardiologist at the Karolinska Institute in Stockholm.
It’s well established that AF is associated with increased risk of dementia, presumably because the arrhythmia kicks out microemboli that get distributed throughout the brain. But it has been unclear whether oral anticoagulation (OAC) prescribed for stroke prevention has the side benefit of reducing the elevated dementia risk.
“A randomized, controlled trial would be ideal to look at this, but it would be impractical and unethical. Second best [would be] a registry study with propensity matching,” according to Dr. Friberg.
And that’s just what he and his coinvestigators carried out. The study included 80,948 AF patients with no baseline diagnosis of dementia who were prescribed an OAC and an equal number of propensity-matched, dementia-free AF patients not on OAC therapy. During up to 8 years of follow-up, the unadjusted risk of a new diagnosis of dementia was 29% lower in the group on an OAC at baseline.
But the Swedish registries also enabled investigators to zero in on the impact of OAC in patients who were actually medication adherent over time. Dr. Friberg and his coworkers identified a subgroup of 50,406 AF patients who regularly filled their OAC prescriptions and took the medication at least 80% of the time, as well as 48,947 propensity-matched controls who never used OACs. In this on-treatment analysis, the OAC users had a robust 48% relative risk reduction in new diagnosis of dementia. The dementia curves diverged almost immediately and the gap between the two curves continued to widen throughout follow-up. All examined subgroups benefited, regardless of age, gender, AF duration, CHA2DS2-VASc score, or the presence or absence of diabetes, renal failure, or frequent falling.
“This is an important issue,” Dr. Friberg declared. “You may say, ‘What do we care about these findings? These patients are all supposed to be on an oral anticoagulant anyway.’ But you know, patients stop taking their oral anticoagulant. We’re pretty good at initiating treatment when we meet patients for the first time, if they have stroke risk factors, but annually, 10%-15% of patients drop out of treatment. And if patients aren’t concerned enough about their risk of stroke, they might be more concerned about the risk of becoming demented. So these data provide an additional argument for the need to persevere with oral anticoagulation therapy.”
Session cochair Gabriel Tatu-Chitoiu, MD, was skeptical.
“I’ve been working in the atrial fibrillation field for 40 years, and I have to say I haven’t seen a strong dementia possibility in my patients,” said Dr. Tatu-Chitoiu, a cardiologist in Bucharest, Romania, and immediate past president of the Romanian Cardiology Society.
Dr. Friberg replied that AF patients are elderly, and many of them may stop going to their cardiologist when they develop dementia.
“I don’t think you can make extensions from personal experience on this. You have to trust in statistical evidence,” he observed.
Dr. Friberg reported receiving research funding from Bayer, Bristol-Myers Squibb, Pfizer, and Sanofi. However, the registry study was carried out without commercial support.
BARCELONA – The risk of developing dementia was reduced by 48% in patients with atrial fibrillation who were adherent to oral anticoagulation compared with those who were not, according to a Swedish propensity-matched registry study involving nearly 162,000 patients with the arrhythmia.
The study also addressed whether patients with atrial fibrillation (AF) are better off in terms of reducing their dementia risk if they’re on warfarin versus one of the novel oral anticoagulants. The answer is that it makes absolutely no difference, Leif Friberg, MD, reported at the annual congress of the European Society of Cardiology.
“We found no difference whatsoever in any of the subgroups. It appears that it is more important that you have some kind of oral treatment than exactly what kind to have,” said Dr. Friberg, a cardiologist at the Karolinska Institute in Stockholm.
It’s well established that AF is associated with increased risk of dementia, presumably because the arrhythmia kicks out microemboli that get distributed throughout the brain. But it has been unclear whether oral anticoagulation (OAC) prescribed for stroke prevention has the side benefit of reducing the elevated dementia risk.
“A randomized, controlled trial would be ideal to look at this, but it would be impractical and unethical. Second best [would be] a registry study with propensity matching,” according to Dr. Friberg.
And that’s just what he and his coinvestigators carried out. The study included 80,948 AF patients with no baseline diagnosis of dementia who were prescribed an OAC and an equal number of propensity-matched, dementia-free AF patients not on OAC therapy. During up to 8 years of follow-up, the unadjusted risk of a new diagnosis of dementia was 29% lower in the group on an OAC at baseline.
But the Swedish registries also enabled investigators to zero in on the impact of OAC in patients who were actually medication adherent over time. Dr. Friberg and his coworkers identified a subgroup of 50,406 AF patients who regularly filled their OAC prescriptions and took the medication at least 80% of the time, as well as 48,947 propensity-matched controls who never used OACs. In this on-treatment analysis, the OAC users had a robust 48% relative risk reduction in new diagnosis of dementia. The dementia curves diverged almost immediately and the gap between the two curves continued to widen throughout follow-up. All examined subgroups benefited, regardless of age, gender, AF duration, CHA2DS2-VASc score, or the presence or absence of diabetes, renal failure, or frequent falling.
“This is an important issue,” Dr. Friberg declared. “You may say, ‘What do we care about these findings? These patients are all supposed to be on an oral anticoagulant anyway.’ But you know, patients stop taking their oral anticoagulant. We’re pretty good at initiating treatment when we meet patients for the first time, if they have stroke risk factors, but annually, 10%-15% of patients drop out of treatment. And if patients aren’t concerned enough about their risk of stroke, they might be more concerned about the risk of becoming demented. So these data provide an additional argument for the need to persevere with oral anticoagulation therapy.”
Session cochair Gabriel Tatu-Chitoiu, MD, was skeptical.
“I’ve been working in the atrial fibrillation field for 40 years, and I have to say I haven’t seen a strong dementia possibility in my patients,” said Dr. Tatu-Chitoiu, a cardiologist in Bucharest, Romania, and immediate past president of the Romanian Cardiology Society.
Dr. Friberg replied that AF patients are elderly, and many of them may stop going to their cardiologist when they develop dementia.
“I don’t think you can make extensions from personal experience on this. You have to trust in statistical evidence,” he observed.
Dr. Friberg reported receiving research funding from Bayer, Bristol-Myers Squibb, Pfizer, and Sanofi. However, the registry study was carried out without commercial support.
BARCELONA – The risk of developing dementia was reduced by 48% in patients with atrial fibrillation who were adherent to oral anticoagulation compared with those who were not, according to a Swedish propensity-matched registry study involving nearly 162,000 patients with the arrhythmia.
The study also addressed whether patients with atrial fibrillation (AF) are better off in terms of reducing their dementia risk if they’re on warfarin versus one of the novel oral anticoagulants. The answer is that it makes absolutely no difference, Leif Friberg, MD, reported at the annual congress of the European Society of Cardiology.
“We found no difference whatsoever in any of the subgroups. It appears that it is more important that you have some kind of oral treatment than exactly what kind to have,” said Dr. Friberg, a cardiologist at the Karolinska Institute in Stockholm.
It’s well established that AF is associated with increased risk of dementia, presumably because the arrhythmia kicks out microemboli that get distributed throughout the brain. But it has been unclear whether oral anticoagulation (OAC) prescribed for stroke prevention has the side benefit of reducing the elevated dementia risk.
“A randomized, controlled trial would be ideal to look at this, but it would be impractical and unethical. Second best [would be] a registry study with propensity matching,” according to Dr. Friberg.
And that’s just what he and his coinvestigators carried out. The study included 80,948 AF patients with no baseline diagnosis of dementia who were prescribed an OAC and an equal number of propensity-matched, dementia-free AF patients not on OAC therapy. During up to 8 years of follow-up, the unadjusted risk of a new diagnosis of dementia was 29% lower in the group on an OAC at baseline.
But the Swedish registries also enabled investigators to zero in on the impact of OAC in patients who were actually medication adherent over time. Dr. Friberg and his coworkers identified a subgroup of 50,406 AF patients who regularly filled their OAC prescriptions and took the medication at least 80% of the time, as well as 48,947 propensity-matched controls who never used OACs. In this on-treatment analysis, the OAC users had a robust 48% relative risk reduction in new diagnosis of dementia. The dementia curves diverged almost immediately and the gap between the two curves continued to widen throughout follow-up. All examined subgroups benefited, regardless of age, gender, AF duration, CHA2DS2-VASc score, or the presence or absence of diabetes, renal failure, or frequent falling.
“This is an important issue,” Dr. Friberg declared. “You may say, ‘What do we care about these findings? These patients are all supposed to be on an oral anticoagulant anyway.’ But you know, patients stop taking their oral anticoagulant. We’re pretty good at initiating treatment when we meet patients for the first time, if they have stroke risk factors, but annually, 10%-15% of patients drop out of treatment. And if patients aren’t concerned enough about their risk of stroke, they might be more concerned about the risk of becoming demented. So these data provide an additional argument for the need to persevere with oral anticoagulation therapy.”
Session cochair Gabriel Tatu-Chitoiu, MD, was skeptical.
“I’ve been working in the atrial fibrillation field for 40 years, and I have to say I haven’t seen a strong dementia possibility in my patients,” said Dr. Tatu-Chitoiu, a cardiologist in Bucharest, Romania, and immediate past president of the Romanian Cardiology Society.
Dr. Friberg replied that AF patients are elderly, and many of them may stop going to their cardiologist when they develop dementia.
“I don’t think you can make extensions from personal experience on this. You have to trust in statistical evidence,” he observed.
Dr. Friberg reported receiving research funding from Bayer, Bristol-Myers Squibb, Pfizer, and Sanofi. However, the registry study was carried out without commercial support.
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: The risk of new diagnosis of dementia during up to 8 years of follow-up was 48% lower in AF patients on an oral anticoagulant at least 80% of the time, compared with those not on the medication.
Data source: This was a Swedish registry study including nearly 162,000 propensity-matched patients with atrial fibrillation free of baseline dementia.
Disclosures: The study was conducted without commercial support.
Psoriasis: Biologics bring potential for long-term remission off treatment
GENEVA – Can potent, highly efficacious biologic therapy induce longstanding remission of moderate to severe plaque psoriasis following discontinuation of all treatment?
The answer appears to be yes, in a minority of patients, based on results of a long-term extension study of two pivotal phase 3 clinical trials of secukinumab (Cosentyx), Mark G. Lebwohl, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
This 2-year extension study provides the first double-blind, long-term evidence regarding the natural history of psoriasis following discontinuation of a contemporary potent targeted therapy.
The results are exciting because spontaneous remission of moderate to severe psoriasis is rare; psoriasis typically reverts to baseline severity following discontinuation of treatment. In the extension study, though, 21% of patients who achieved a 75% reduction in the Psoriasis Area Severity Index (PASI 75) response on secukinumab at the 300-mg dose for 52 weeks and were then crossed over double-blind to placebo remained continuously relapse-free after 12 months on placebo, and 10% remained relapse-free at 2 years, at which point they were unblinded and put back on secukinumab. No psoriasis therapies were permitted during the placebo phase.
Those findings are particularly impressive because participants in the two pivotal trials of secukinumab combined for the treatment withdrawal extension study – ERASURE and FIXTURE – had a mean 14- and 16-year history of psoriasis at baseline.
“Secukinumab appears to have modified the course of chronic moderate to severe psoriasis, despite intervening late in its course. Treating patients early is expected to have an even greater potential for disease modification,” commented Dr. Lebwohl, the Sol and Clara Kest Professor and chair of the department of dermatology at Icahn School of Medicine at Mount Sinai, New York.
That hypothesis is under investigation in the ongoing multinational STEPin trial (Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. [subcutaneous] Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis). STEPin involves about 200 patients with newly diagnosed disease not previously treated with systemic agents or phototherapy.
Dr. Lebwohl focused on the 120 patients in the extension study who had a PASI 75 response to secukinumab at the 300-mg dose and the 100 patients with a PASI 75 response to the 150-mg dose who, after 52 weeks on the fully human anti-interleukin-17A monoclonal antibody, were crossed over double-blind to placebo for 2 years or until relapse occurred. Patients were assessed monthly during the extension study.
Relapse was defined as loss of 50% of the maximum PASI improvement achieved while on secukinumab. The relapse-free rate was better in patients who had been on secukinumab 300 mg than in those on 150 mg. At 1 year on placebo, 21% of patients formerly on secukinumab at the higher dose remained free of relapse, as did 10% at 2 years. In contrast, the 1- and 2-year relapse-free rates in the group formerly on secukinumab 150 mg were lower at 14% and 6%, respectively, even though everyone in the extension study had a PASI 75 response when they went off treatment.
The mean baseline PASI score in the ERASURE and FIXTURE trials was 23. Among patients who remained relapse-free for 1 year, the mean PASI score was dramatically lower, at 0.7; among those in remission for 2 years, it was 0.4.
Importantly, the longer a patient’s history of psoriasis, the less likely a long-term relapse-free experience, the dermatologist observed.
A separate mechanistic study in a different group of psoriasis patients provided a likely explanation for the long relapse-free period seen off therapy in some patients in the extension study. The mechanistic study entailed transcriptional analysis of psoriasis-related genes in lesional and nonlesional skin before and after 1 year of treatment with secukinumab 300 mg. The major finding: 85% of the upregulated genes and 75% of downregulated genes in lesional skin pretreatment reverted to normal levels in healed lesional skin post treatment.
Moreover, global mRNA expression for key genes involved in the interleukin-23/interleukin-17 inflammatory cytokine pathway closely resembled healthy skin following treatment with secukinumab. This is evidence of profound molecular normalization, Dr. Lebwohl said.
These secukinumab studies were sponsored by Novartis. Dr. Lebwohl reported having no personal financial conflicts of interest, although his department receives research funding from Novartis and numerous other pharmaceutical companies.
GENEVA – Can potent, highly efficacious biologic therapy induce longstanding remission of moderate to severe plaque psoriasis following discontinuation of all treatment?
The answer appears to be yes, in a minority of patients, based on results of a long-term extension study of two pivotal phase 3 clinical trials of secukinumab (Cosentyx), Mark G. Lebwohl, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
This 2-year extension study provides the first double-blind, long-term evidence regarding the natural history of psoriasis following discontinuation of a contemporary potent targeted therapy.
The results are exciting because spontaneous remission of moderate to severe psoriasis is rare; psoriasis typically reverts to baseline severity following discontinuation of treatment. In the extension study, though, 21% of patients who achieved a 75% reduction in the Psoriasis Area Severity Index (PASI 75) response on secukinumab at the 300-mg dose for 52 weeks and were then crossed over double-blind to placebo remained continuously relapse-free after 12 months on placebo, and 10% remained relapse-free at 2 years, at which point they were unblinded and put back on secukinumab. No psoriasis therapies were permitted during the placebo phase.
Those findings are particularly impressive because participants in the two pivotal trials of secukinumab combined for the treatment withdrawal extension study – ERASURE and FIXTURE – had a mean 14- and 16-year history of psoriasis at baseline.
“Secukinumab appears to have modified the course of chronic moderate to severe psoriasis, despite intervening late in its course. Treating patients early is expected to have an even greater potential for disease modification,” commented Dr. Lebwohl, the Sol and Clara Kest Professor and chair of the department of dermatology at Icahn School of Medicine at Mount Sinai, New York.
That hypothesis is under investigation in the ongoing multinational STEPin trial (Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. [subcutaneous] Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis). STEPin involves about 200 patients with newly diagnosed disease not previously treated with systemic agents or phototherapy.
Dr. Lebwohl focused on the 120 patients in the extension study who had a PASI 75 response to secukinumab at the 300-mg dose and the 100 patients with a PASI 75 response to the 150-mg dose who, after 52 weeks on the fully human anti-interleukin-17A monoclonal antibody, were crossed over double-blind to placebo for 2 years or until relapse occurred. Patients were assessed monthly during the extension study.
Relapse was defined as loss of 50% of the maximum PASI improvement achieved while on secukinumab. The relapse-free rate was better in patients who had been on secukinumab 300 mg than in those on 150 mg. At 1 year on placebo, 21% of patients formerly on secukinumab at the higher dose remained free of relapse, as did 10% at 2 years. In contrast, the 1- and 2-year relapse-free rates in the group formerly on secukinumab 150 mg were lower at 14% and 6%, respectively, even though everyone in the extension study had a PASI 75 response when they went off treatment.
The mean baseline PASI score in the ERASURE and FIXTURE trials was 23. Among patients who remained relapse-free for 1 year, the mean PASI score was dramatically lower, at 0.7; among those in remission for 2 years, it was 0.4.
Importantly, the longer a patient’s history of psoriasis, the less likely a long-term relapse-free experience, the dermatologist observed.
A separate mechanistic study in a different group of psoriasis patients provided a likely explanation for the long relapse-free period seen off therapy in some patients in the extension study. The mechanistic study entailed transcriptional analysis of psoriasis-related genes in lesional and nonlesional skin before and after 1 year of treatment with secukinumab 300 mg. The major finding: 85% of the upregulated genes and 75% of downregulated genes in lesional skin pretreatment reverted to normal levels in healed lesional skin post treatment.
Moreover, global mRNA expression for key genes involved in the interleukin-23/interleukin-17 inflammatory cytokine pathway closely resembled healthy skin following treatment with secukinumab. This is evidence of profound molecular normalization, Dr. Lebwohl said.
These secukinumab studies were sponsored by Novartis. Dr. Lebwohl reported having no personal financial conflicts of interest, although his department receives research funding from Novartis and numerous other pharmaceutical companies.
GENEVA – Can potent, highly efficacious biologic therapy induce longstanding remission of moderate to severe plaque psoriasis following discontinuation of all treatment?
The answer appears to be yes, in a minority of patients, based on results of a long-term extension study of two pivotal phase 3 clinical trials of secukinumab (Cosentyx), Mark G. Lebwohl, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
This 2-year extension study provides the first double-blind, long-term evidence regarding the natural history of psoriasis following discontinuation of a contemporary potent targeted therapy.
The results are exciting because spontaneous remission of moderate to severe psoriasis is rare; psoriasis typically reverts to baseline severity following discontinuation of treatment. In the extension study, though, 21% of patients who achieved a 75% reduction in the Psoriasis Area Severity Index (PASI 75) response on secukinumab at the 300-mg dose for 52 weeks and were then crossed over double-blind to placebo remained continuously relapse-free after 12 months on placebo, and 10% remained relapse-free at 2 years, at which point they were unblinded and put back on secukinumab. No psoriasis therapies were permitted during the placebo phase.
Those findings are particularly impressive because participants in the two pivotal trials of secukinumab combined for the treatment withdrawal extension study – ERASURE and FIXTURE – had a mean 14- and 16-year history of psoriasis at baseline.
“Secukinumab appears to have modified the course of chronic moderate to severe psoriasis, despite intervening late in its course. Treating patients early is expected to have an even greater potential for disease modification,” commented Dr. Lebwohl, the Sol and Clara Kest Professor and chair of the department of dermatology at Icahn School of Medicine at Mount Sinai, New York.
That hypothesis is under investigation in the ongoing multinational STEPin trial (Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. [subcutaneous] Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis). STEPin involves about 200 patients with newly diagnosed disease not previously treated with systemic agents or phototherapy.
Dr. Lebwohl focused on the 120 patients in the extension study who had a PASI 75 response to secukinumab at the 300-mg dose and the 100 patients with a PASI 75 response to the 150-mg dose who, after 52 weeks on the fully human anti-interleukin-17A monoclonal antibody, were crossed over double-blind to placebo for 2 years or until relapse occurred. Patients were assessed monthly during the extension study.
Relapse was defined as loss of 50% of the maximum PASI improvement achieved while on secukinumab. The relapse-free rate was better in patients who had been on secukinumab 300 mg than in those on 150 mg. At 1 year on placebo, 21% of patients formerly on secukinumab at the higher dose remained free of relapse, as did 10% at 2 years. In contrast, the 1- and 2-year relapse-free rates in the group formerly on secukinumab 150 mg were lower at 14% and 6%, respectively, even though everyone in the extension study had a PASI 75 response when they went off treatment.
The mean baseline PASI score in the ERASURE and FIXTURE trials was 23. Among patients who remained relapse-free for 1 year, the mean PASI score was dramatically lower, at 0.7; among those in remission for 2 years, it was 0.4.
Importantly, the longer a patient’s history of psoriasis, the less likely a long-term relapse-free experience, the dermatologist observed.
A separate mechanistic study in a different group of psoriasis patients provided a likely explanation for the long relapse-free period seen off therapy in some patients in the extension study. The mechanistic study entailed transcriptional analysis of psoriasis-related genes in lesional and nonlesional skin before and after 1 year of treatment with secukinumab 300 mg. The major finding: 85% of the upregulated genes and 75% of downregulated genes in lesional skin pretreatment reverted to normal levels in healed lesional skin post treatment.
Moreover, global mRNA expression for key genes involved in the interleukin-23/interleukin-17 inflammatory cytokine pathway closely resembled healthy skin following treatment with secukinumab. This is evidence of profound molecular normalization, Dr. Lebwohl said.
These secukinumab studies were sponsored by Novartis. Dr. Lebwohl reported having no personal financial conflicts of interest, although his department receives research funding from Novartis and numerous other pharmaceutical companies.
AT THE EADV CONGRESS
Key clinical point: , enabling some patients to experience long-term remission off therapy.
Major finding: After 1 and 2 years without any psoriasis therapy following successful treatment with secukinumab for 52 weeks, 21% and 10% of patients, respectively, remained relapse-free.
Data source: This prospective extension of two phase 3 pivotal trials of secukinumab included 220 psoriasis patients who were taken off the biologic after 52 weeks and crossed over double blind to placebo for up to 2 years.
Disclosures: The study was sponsored by Novartis. Dr. Lebwohl reported having no financial conflicts.
Abnormal potassium plus suspected ACS spell trouble
BARCELONA – A serum potassium level of at least 5.0 mmol/L or 3.5 mmol/L or less at admission for suspected acute coronary syndrome is a red flag for increased risk of in-hospital mortality and cardiac arrest, according to a Swedish study of nearly 33,000 consecutive patients.
That’s true even if, as so often ultimately proves to be the case, the patient turns out not to have ACS, Jonas Faxén, MD, of the Karolinska Institute, Stockholm, reported at the annual congress of the European Society of Cardiology.
“This study highlights that, if you have a patient in the emergency department with a possible ACS and potassium imbalance, you should really be cautious,” Dr. Faxén said.
He reported on 32,955 consecutive patients admitted to Stockholm County hospitals for suspected ACS during 2006-2011 and thereby enrolled in the SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry.
Overall in-hospital mortality was 2.7%. In-hospital cardiac arrest occurred in 1.5% of patients. New-onset atrial fibrillation occurred in 2.4% of patients. These key outcomes were compared between the reference group – defined as patients with an admission serum potassium of 3.5 to less than 4.0 mmol/L – and patients with an admission serum potassium above or below those cutoffs.
In a multivariate logistic regression analysis adjusted for 24 potential confounders, including demographics, presentation characteristics, main diagnosis, comorbid conditions, medications on admission, and estimated glomerular filtration rate, patients with a serum potassium of 5.0 to less than 5.5 mmol/L were at 1.8-fold increased risk of in-hospital mortality. Those with a potassium of 5.5 mmol/L or greater were at 2.3-fold increased risk.
In contrast, a low rather than a high serum potassium was an independent risk factor cardiac arrest. An admission potassium of 3.0 to less than 3.5 mmol/L carried a 1.8-fold increased risk of in-hospital cardiac arrest, while a potassium of less than 3.0 was associated with a 2.7-fold increased risk.
A serum potassium below 3.0 mmol/L at admission also was associated with a 1.7-fold increased risk of new-onset atrial fibrillation.
These elevated risks of bad outcomes didn’t differ significantly between patients with ST-elevation MI, non-STEMI ACS, and those whose final diagnosis was not ACS, Dr. Faxén noted.
Session cochair David W. Walker, MD, medical director of the East Sussex (England) Healthcare NHS Trust, observed, “When I was a junior doctor I was always taught that when patients came onto coronary care we had to get their potassium to 4.5-5.0 mmol/L. I think you might want to change that advice now.”
“The implication would be that, if you intervene quickly in a patient with an abnormal potassium level, you might make a difference. Clearly, a potassium that’s too high is much worse than too low, since patients with in-hospital cardiac arrest can often be resuscitated,” Dr. Walker commented.
Dr. Faxén reported having no financial conflicts regarding his study, which was funded by the Swedish Heart and Lung Foundation and the Stockholm County Council.
BARCELONA – A serum potassium level of at least 5.0 mmol/L or 3.5 mmol/L or less at admission for suspected acute coronary syndrome is a red flag for increased risk of in-hospital mortality and cardiac arrest, according to a Swedish study of nearly 33,000 consecutive patients.
That’s true even if, as so often ultimately proves to be the case, the patient turns out not to have ACS, Jonas Faxén, MD, of the Karolinska Institute, Stockholm, reported at the annual congress of the European Society of Cardiology.
“This study highlights that, if you have a patient in the emergency department with a possible ACS and potassium imbalance, you should really be cautious,” Dr. Faxén said.
He reported on 32,955 consecutive patients admitted to Stockholm County hospitals for suspected ACS during 2006-2011 and thereby enrolled in the SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry.
Overall in-hospital mortality was 2.7%. In-hospital cardiac arrest occurred in 1.5% of patients. New-onset atrial fibrillation occurred in 2.4% of patients. These key outcomes were compared between the reference group – defined as patients with an admission serum potassium of 3.5 to less than 4.0 mmol/L – and patients with an admission serum potassium above or below those cutoffs.
In a multivariate logistic regression analysis adjusted for 24 potential confounders, including demographics, presentation characteristics, main diagnosis, comorbid conditions, medications on admission, and estimated glomerular filtration rate, patients with a serum potassium of 5.0 to less than 5.5 mmol/L were at 1.8-fold increased risk of in-hospital mortality. Those with a potassium of 5.5 mmol/L or greater were at 2.3-fold increased risk.
In contrast, a low rather than a high serum potassium was an independent risk factor cardiac arrest. An admission potassium of 3.0 to less than 3.5 mmol/L carried a 1.8-fold increased risk of in-hospital cardiac arrest, while a potassium of less than 3.0 was associated with a 2.7-fold increased risk.
A serum potassium below 3.0 mmol/L at admission also was associated with a 1.7-fold increased risk of new-onset atrial fibrillation.
These elevated risks of bad outcomes didn’t differ significantly between patients with ST-elevation MI, non-STEMI ACS, and those whose final diagnosis was not ACS, Dr. Faxén noted.
Session cochair David W. Walker, MD, medical director of the East Sussex (England) Healthcare NHS Trust, observed, “When I was a junior doctor I was always taught that when patients came onto coronary care we had to get their potassium to 4.5-5.0 mmol/L. I think you might want to change that advice now.”
“The implication would be that, if you intervene quickly in a patient with an abnormal potassium level, you might make a difference. Clearly, a potassium that’s too high is much worse than too low, since patients with in-hospital cardiac arrest can often be resuscitated,” Dr. Walker commented.
Dr. Faxén reported having no financial conflicts regarding his study, which was funded by the Swedish Heart and Lung Foundation and the Stockholm County Council.
BARCELONA – A serum potassium level of at least 5.0 mmol/L or 3.5 mmol/L or less at admission for suspected acute coronary syndrome is a red flag for increased risk of in-hospital mortality and cardiac arrest, according to a Swedish study of nearly 33,000 consecutive patients.
That’s true even if, as so often ultimately proves to be the case, the patient turns out not to have ACS, Jonas Faxén, MD, of the Karolinska Institute, Stockholm, reported at the annual congress of the European Society of Cardiology.
“This study highlights that, if you have a patient in the emergency department with a possible ACS and potassium imbalance, you should really be cautious,” Dr. Faxén said.
He reported on 32,955 consecutive patients admitted to Stockholm County hospitals for suspected ACS during 2006-2011 and thereby enrolled in the SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry.
Overall in-hospital mortality was 2.7%. In-hospital cardiac arrest occurred in 1.5% of patients. New-onset atrial fibrillation occurred in 2.4% of patients. These key outcomes were compared between the reference group – defined as patients with an admission serum potassium of 3.5 to less than 4.0 mmol/L – and patients with an admission serum potassium above or below those cutoffs.
In a multivariate logistic regression analysis adjusted for 24 potential confounders, including demographics, presentation characteristics, main diagnosis, comorbid conditions, medications on admission, and estimated glomerular filtration rate, patients with a serum potassium of 5.0 to less than 5.5 mmol/L were at 1.8-fold increased risk of in-hospital mortality. Those with a potassium of 5.5 mmol/L or greater were at 2.3-fold increased risk.
In contrast, a low rather than a high serum potassium was an independent risk factor cardiac arrest. An admission potassium of 3.0 to less than 3.5 mmol/L carried a 1.8-fold increased risk of in-hospital cardiac arrest, while a potassium of less than 3.0 was associated with a 2.7-fold increased risk.
A serum potassium below 3.0 mmol/L at admission also was associated with a 1.7-fold increased risk of new-onset atrial fibrillation.
These elevated risks of bad outcomes didn’t differ significantly between patients with ST-elevation MI, non-STEMI ACS, and those whose final diagnosis was not ACS, Dr. Faxén noted.
Session cochair David W. Walker, MD, medical director of the East Sussex (England) Healthcare NHS Trust, observed, “When I was a junior doctor I was always taught that when patients came onto coronary care we had to get their potassium to 4.5-5.0 mmol/L. I think you might want to change that advice now.”
“The implication would be that, if you intervene quickly in a patient with an abnormal potassium level, you might make a difference. Clearly, a potassium that’s too high is much worse than too low, since patients with in-hospital cardiac arrest can often be resuscitated,” Dr. Walker commented.
Dr. Faxén reported having no financial conflicts regarding his study, which was funded by the Swedish Heart and Lung Foundation and the Stockholm County Council.
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: Hyperkalemia of 5.0 to less than 5.5 mmol/L at admission for suspected ACS was associated with close to a twofold increased risk of in-hospital mortality.
Data source: The SWEDEHEART study is an ongoing prospective registry of patients with cardiovascular disease admitted to Stockholm County hospitals.
Disclosures: The presenter reported having no financial conflicts regarding his study, which was funded by the Swedish Heart and Lung Foundation and the Stockholm County Council.
Fentanyl in the cath lab questioned
BARCELONA – The current routine use of intravenous fentanyl in the cardiac catheterization lab for patient comfort during coronary angiography has been called into question by the results of a double-blind randomized trial presented at the annual congress of the European Society of Cardiology.
The trial, known as PACIFY, showed that IV fentanyl delayed absorption of the oral P2Y12 inhibitor ticagrelor (Brilinta) by up to 4 hours. That’s a disturbing finding that could account for the relatively high risk of stent thrombosis in the first hours after percutaneous coronary intervention, according to lead investigator John W. McEvoy, MD, a cardiologist at Johns Hopkins University in Baltimore.
“These data challenge the routine and nonselective use of fentanyl for cardiac catheterization and PCI, particularly when rapid platelet inhibition is desirable,” he said, adding, “This would represent a significant change in U.S. cath lab practice.”
PACIFY (Platelet Aggregation After Ticagrelor Inhibition and Fentanyl) was a single-center trial in which 212 patients undergoing PCI were randomized in double-blind fashion to fentanyl or no fentanyl on top of a local anesthetic and IV midazolam (Versed). In addition, the 70 subjects undergoing PCI with stent placement received a 180-mg loading dose of ticagrelor intraprocedurally.
The primary endpoint was ticagrelor plasma concentration during the first 24 hours after the drug’s administration. Secondary endpoints were patients’ self-reported maximum pain during the procedure and platelet inhibition at 2 hours.
The plasma concentration time area under the curve over the course of 24 hours was superior in the no-fentanyl group by a margin of 3,441 ng/mL–1 per hour to 2,016 ng/mL–1 per hour. Moreover, 37% of fentanyl recipients displayed high platelet reactivity at 2 hours as measured by light transmission platelet aggregometry, compared with none of the no-fentanyl controls.
Pain was similarly well controlled in both treatment arms, casting doubt on the widespread belief among U.S. interventionalists that routine administration of fentanyl in the cath lab is necessary for patient comfort. Patients in the control arm could receive bailout fentanyl upon request; only two did so.
Dr. McEvoy reported having no financial conflicts regarding this study, which was conducted free of commercial support.
BARCELONA – The current routine use of intravenous fentanyl in the cardiac catheterization lab for patient comfort during coronary angiography has been called into question by the results of a double-blind randomized trial presented at the annual congress of the European Society of Cardiology.
The trial, known as PACIFY, showed that IV fentanyl delayed absorption of the oral P2Y12 inhibitor ticagrelor (Brilinta) by up to 4 hours. That’s a disturbing finding that could account for the relatively high risk of stent thrombosis in the first hours after percutaneous coronary intervention, according to lead investigator John W. McEvoy, MD, a cardiologist at Johns Hopkins University in Baltimore.
“These data challenge the routine and nonselective use of fentanyl for cardiac catheterization and PCI, particularly when rapid platelet inhibition is desirable,” he said, adding, “This would represent a significant change in U.S. cath lab practice.”
PACIFY (Platelet Aggregation After Ticagrelor Inhibition and Fentanyl) was a single-center trial in which 212 patients undergoing PCI were randomized in double-blind fashion to fentanyl or no fentanyl on top of a local anesthetic and IV midazolam (Versed). In addition, the 70 subjects undergoing PCI with stent placement received a 180-mg loading dose of ticagrelor intraprocedurally.
The primary endpoint was ticagrelor plasma concentration during the first 24 hours after the drug’s administration. Secondary endpoints were patients’ self-reported maximum pain during the procedure and platelet inhibition at 2 hours.
The plasma concentration time area under the curve over the course of 24 hours was superior in the no-fentanyl group by a margin of 3,441 ng/mL–1 per hour to 2,016 ng/mL–1 per hour. Moreover, 37% of fentanyl recipients displayed high platelet reactivity at 2 hours as measured by light transmission platelet aggregometry, compared with none of the no-fentanyl controls.
Pain was similarly well controlled in both treatment arms, casting doubt on the widespread belief among U.S. interventionalists that routine administration of fentanyl in the cath lab is necessary for patient comfort. Patients in the control arm could receive bailout fentanyl upon request; only two did so.
Dr. McEvoy reported having no financial conflicts regarding this study, which was conducted free of commercial support.
BARCELONA – The current routine use of intravenous fentanyl in the cardiac catheterization lab for patient comfort during coronary angiography has been called into question by the results of a double-blind randomized trial presented at the annual congress of the European Society of Cardiology.
The trial, known as PACIFY, showed that IV fentanyl delayed absorption of the oral P2Y12 inhibitor ticagrelor (Brilinta) by up to 4 hours. That’s a disturbing finding that could account for the relatively high risk of stent thrombosis in the first hours after percutaneous coronary intervention, according to lead investigator John W. McEvoy, MD, a cardiologist at Johns Hopkins University in Baltimore.
“These data challenge the routine and nonselective use of fentanyl for cardiac catheterization and PCI, particularly when rapid platelet inhibition is desirable,” he said, adding, “This would represent a significant change in U.S. cath lab practice.”
PACIFY (Platelet Aggregation After Ticagrelor Inhibition and Fentanyl) was a single-center trial in which 212 patients undergoing PCI were randomized in double-blind fashion to fentanyl or no fentanyl on top of a local anesthetic and IV midazolam (Versed). In addition, the 70 subjects undergoing PCI with stent placement received a 180-mg loading dose of ticagrelor intraprocedurally.
The primary endpoint was ticagrelor plasma concentration during the first 24 hours after the drug’s administration. Secondary endpoints were patients’ self-reported maximum pain during the procedure and platelet inhibition at 2 hours.
The plasma concentration time area under the curve over the course of 24 hours was superior in the no-fentanyl group by a margin of 3,441 ng/mL–1 per hour to 2,016 ng/mL–1 per hour. Moreover, 37% of fentanyl recipients displayed high platelet reactivity at 2 hours as measured by light transmission platelet aggregometry, compared with none of the no-fentanyl controls.
Pain was similarly well controlled in both treatment arms, casting doubt on the widespread belief among U.S. interventionalists that routine administration of fentanyl in the cath lab is necessary for patient comfort. Patients in the control arm could receive bailout fentanyl upon request; only two did so.
Dr. McEvoy reported having no financial conflicts regarding this study, which was conducted free of commercial support.
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: High platelet reactivity at 2 hours was present in 37% of patients who underwent coronary angiography with IV fentanyl and in none randomized to going without the opiate.
Data source: PACIFY, a single-center, double-blind, randomized trial included 212 patients undergoing coronary angiography.
Disclosures: The presenter reported having no financial conflicts regarding this study, which was conducted free of commercial support.