User login
Expert reviews options for refractory pediatric warts
For refractory warts, there are some “last resort” treatments every dermatologist should have on hand, according to pediatric dermatologist Fred E. Ghali, MD.
“It’s good to know about these, although it’s also good to know that sometimes you just have to wait out the warts and let them clear up on their own,” said Dr. Ghali, of the departments of dermatology at University of Texas, Dallas, and Baylor College of Medicine, Houston. Because very few treatment options are approved for warts, Dr. Ghali shared some of his preferred off-label approaches at the meeting provided by Global Academy for Medical Education.
By the time patients make it to his clinic, Dr. Ghali noted that many patients have failed home remedies such as salicylic acid or duct tape. In some cases, however, warts may not respond well to the standard in-office options such as cryotherapy. For refractory cases, he said that one of the following approaches can be considered:
Sectional cryotherapy
For larger, solitary warts, especially ring warts, freezing them in sections can be a good option, according to Dr. Ghali. This can be done best using a cotton-tip applicator rather than the traditional spray gun. In his experience, this minimizes the risk of ring wart formation, which may occur from aggressive cryotherapy focused primarily on the central portion of the wart, sometimes creating a resultant blister much larger than the original wart, with the formation of a ring wart.
Topical immunotherapy
When it comes to refractory cases in younger children, or in cases with multiple warts on the hands and feet, topical immunotherapy is often a preferred treatment. In these cases, Dr. Ghali recommended squaric acid. “The general principle with topical immunotherapy is that you would induce contact allergy with the treatment by applying it to one place on the skin, usually the arm, in the office setting,” he said. If using squaric acid, he recommended starting with 2% to sensitize in the office; then for home use, prescribing a lower concentration of the treatment – usually 0.6% – painted directly onto the lesions to provoke an immune response. This should be done three times a week at first, and then adding one application each week until the warts are being treated daily.
“If there is no response in 2 months, then increase the strength used at home,” Dr. Ghali said.
With this treatment, there is the potential for contact dermatitis, which is usually localized, but can be widespread beyond the areas of application, he cautioned. When this occurs, he recommended decreasing or discontinuing the applications and considering a topical steroid or oral steroid depending upon the severity of the reaction. “I mainly use squaric acid for the hands and feet, and almost always avoid it on the face, neck, and groin,” Dr. Ghali said.
In his practice, he finds this treatment is effective about three-quarters of the time, and seems to work particularly well with plantar warts, clearing them up in 2-4 months. The advantages of this approach are that it is not painful, is relatively easy for patients to comply with, and can be combined with other treatments if desired.
Intralesional immunotherapy
When squaric acid or cryotherapy fails, Candida antigen injection is a commonly used technique used to train the immune system to attack the warts, inducing a delayed hypersensitivity reaction. “Injectable immunotherapy is ideal in cases of a solitary [wart] or a limited number of warts,” Dr. Ghali said in an interview. “For most patients, I typically inject 0.1-0.2 cc of Candida antigen per wart. In the case of larger, ring-type warts, especially on the knees and elbows, we may need to use larger volumes, up to 0.2 cc-0.6cc,” he added.
“It’s important to remind patients that temporary, localized swelling may occur after injections; thus, care should be taken when injecting near periungual locations,” Dr. Ghali continued, noting that “it’s probably best practice to avoid subungual injections.”
Immunotherapy has relatively few side effects, and may be effective in about three-quarters of cases, according to Dr. Ghali, although he cautioned that younger children may be anxious about receiving injections and may resist treatment.
Electrodessication and curettage
For challenging warts, such as stubborn palmar or plantar warts, Dr. Ghali suggested using local anesthesia plus electrodessication and curettage.
“Sometimes with these refractory warts, we resort to off-label therapies compounded for home use,” he added. Such therapies may include salicylic acid with 5-fluorouracil, or topical cidofovir 2%-3%. These compounds can be costly depending upon the patient’s insurance coverage.
Dr. Ghali concluded by presenting his top three rules to consider when treating warts, regardless of treatment: There is no cure for warts, no therapy is uniformly effective, and the chosen therapy should take into account the family’s costs, according to their insurance coverage.
Since the landscape of insurance coverage has changed over recent years, the code most often used to treat warts in the office, often applies to the patient’s or family’s deductible. “It’s important to discuss this with the family beforehand, especially since treatment for warts may require several visits,” he said.
Dr. Ghali disclosed several financial relationships with the pharmaceutical industry including Astellas, Galderma, and Valeant, among others.
Global Academy and this news organization are owned by the same parent company.
[email protected]
On Twitter @whitneymcknight
For refractory warts, there are some “last resort” treatments every dermatologist should have on hand, according to pediatric dermatologist Fred E. Ghali, MD.
“It’s good to know about these, although it’s also good to know that sometimes you just have to wait out the warts and let them clear up on their own,” said Dr. Ghali, of the departments of dermatology at University of Texas, Dallas, and Baylor College of Medicine, Houston. Because very few treatment options are approved for warts, Dr. Ghali shared some of his preferred off-label approaches at the meeting provided by Global Academy for Medical Education.
By the time patients make it to his clinic, Dr. Ghali noted that many patients have failed home remedies such as salicylic acid or duct tape. In some cases, however, warts may not respond well to the standard in-office options such as cryotherapy. For refractory cases, he said that one of the following approaches can be considered:
Sectional cryotherapy
For larger, solitary warts, especially ring warts, freezing them in sections can be a good option, according to Dr. Ghali. This can be done best using a cotton-tip applicator rather than the traditional spray gun. In his experience, this minimizes the risk of ring wart formation, which may occur from aggressive cryotherapy focused primarily on the central portion of the wart, sometimes creating a resultant blister much larger than the original wart, with the formation of a ring wart.
Topical immunotherapy
When it comes to refractory cases in younger children, or in cases with multiple warts on the hands and feet, topical immunotherapy is often a preferred treatment. In these cases, Dr. Ghali recommended squaric acid. “The general principle with topical immunotherapy is that you would induce contact allergy with the treatment by applying it to one place on the skin, usually the arm, in the office setting,” he said. If using squaric acid, he recommended starting with 2% to sensitize in the office; then for home use, prescribing a lower concentration of the treatment – usually 0.6% – painted directly onto the lesions to provoke an immune response. This should be done three times a week at first, and then adding one application each week until the warts are being treated daily.
“If there is no response in 2 months, then increase the strength used at home,” Dr. Ghali said.
With this treatment, there is the potential for contact dermatitis, which is usually localized, but can be widespread beyond the areas of application, he cautioned. When this occurs, he recommended decreasing or discontinuing the applications and considering a topical steroid or oral steroid depending upon the severity of the reaction. “I mainly use squaric acid for the hands and feet, and almost always avoid it on the face, neck, and groin,” Dr. Ghali said.
In his practice, he finds this treatment is effective about three-quarters of the time, and seems to work particularly well with plantar warts, clearing them up in 2-4 months. The advantages of this approach are that it is not painful, is relatively easy for patients to comply with, and can be combined with other treatments if desired.
Intralesional immunotherapy
When squaric acid or cryotherapy fails, Candida antigen injection is a commonly used technique used to train the immune system to attack the warts, inducing a delayed hypersensitivity reaction. “Injectable immunotherapy is ideal in cases of a solitary [wart] or a limited number of warts,” Dr. Ghali said in an interview. “For most patients, I typically inject 0.1-0.2 cc of Candida antigen per wart. In the case of larger, ring-type warts, especially on the knees and elbows, we may need to use larger volumes, up to 0.2 cc-0.6cc,” he added.
“It’s important to remind patients that temporary, localized swelling may occur after injections; thus, care should be taken when injecting near periungual locations,” Dr. Ghali continued, noting that “it’s probably best practice to avoid subungual injections.”
Immunotherapy has relatively few side effects, and may be effective in about three-quarters of cases, according to Dr. Ghali, although he cautioned that younger children may be anxious about receiving injections and may resist treatment.
Electrodessication and curettage
For challenging warts, such as stubborn palmar or plantar warts, Dr. Ghali suggested using local anesthesia plus electrodessication and curettage.
“Sometimes with these refractory warts, we resort to off-label therapies compounded for home use,” he added. Such therapies may include salicylic acid with 5-fluorouracil, or topical cidofovir 2%-3%. These compounds can be costly depending upon the patient’s insurance coverage.
Dr. Ghali concluded by presenting his top three rules to consider when treating warts, regardless of treatment: There is no cure for warts, no therapy is uniformly effective, and the chosen therapy should take into account the family’s costs, according to their insurance coverage.
Since the landscape of insurance coverage has changed over recent years, the code most often used to treat warts in the office, often applies to the patient’s or family’s deductible. “It’s important to discuss this with the family beforehand, especially since treatment for warts may require several visits,” he said.
Dr. Ghali disclosed several financial relationships with the pharmaceutical industry including Astellas, Galderma, and Valeant, among others.
Global Academy and this news organization are owned by the same parent company.
[email protected]
On Twitter @whitneymcknight
For refractory warts, there are some “last resort” treatments every dermatologist should have on hand, according to pediatric dermatologist Fred E. Ghali, MD.
“It’s good to know about these, although it’s also good to know that sometimes you just have to wait out the warts and let them clear up on their own,” said Dr. Ghali, of the departments of dermatology at University of Texas, Dallas, and Baylor College of Medicine, Houston. Because very few treatment options are approved for warts, Dr. Ghali shared some of his preferred off-label approaches at the meeting provided by Global Academy for Medical Education.
By the time patients make it to his clinic, Dr. Ghali noted that many patients have failed home remedies such as salicylic acid or duct tape. In some cases, however, warts may not respond well to the standard in-office options such as cryotherapy. For refractory cases, he said that one of the following approaches can be considered:
Sectional cryotherapy
For larger, solitary warts, especially ring warts, freezing them in sections can be a good option, according to Dr. Ghali. This can be done best using a cotton-tip applicator rather than the traditional spray gun. In his experience, this minimizes the risk of ring wart formation, which may occur from aggressive cryotherapy focused primarily on the central portion of the wart, sometimes creating a resultant blister much larger than the original wart, with the formation of a ring wart.
Topical immunotherapy
When it comes to refractory cases in younger children, or in cases with multiple warts on the hands and feet, topical immunotherapy is often a preferred treatment. In these cases, Dr. Ghali recommended squaric acid. “The general principle with topical immunotherapy is that you would induce contact allergy with the treatment by applying it to one place on the skin, usually the arm, in the office setting,” he said. If using squaric acid, he recommended starting with 2% to sensitize in the office; then for home use, prescribing a lower concentration of the treatment – usually 0.6% – painted directly onto the lesions to provoke an immune response. This should be done three times a week at first, and then adding one application each week until the warts are being treated daily.
“If there is no response in 2 months, then increase the strength used at home,” Dr. Ghali said.
With this treatment, there is the potential for contact dermatitis, which is usually localized, but can be widespread beyond the areas of application, he cautioned. When this occurs, he recommended decreasing or discontinuing the applications and considering a topical steroid or oral steroid depending upon the severity of the reaction. “I mainly use squaric acid for the hands and feet, and almost always avoid it on the face, neck, and groin,” Dr. Ghali said.
In his practice, he finds this treatment is effective about three-quarters of the time, and seems to work particularly well with plantar warts, clearing them up in 2-4 months. The advantages of this approach are that it is not painful, is relatively easy for patients to comply with, and can be combined with other treatments if desired.
Intralesional immunotherapy
When squaric acid or cryotherapy fails, Candida antigen injection is a commonly used technique used to train the immune system to attack the warts, inducing a delayed hypersensitivity reaction. “Injectable immunotherapy is ideal in cases of a solitary [wart] or a limited number of warts,” Dr. Ghali said in an interview. “For most patients, I typically inject 0.1-0.2 cc of Candida antigen per wart. In the case of larger, ring-type warts, especially on the knees and elbows, we may need to use larger volumes, up to 0.2 cc-0.6cc,” he added.
“It’s important to remind patients that temporary, localized swelling may occur after injections; thus, care should be taken when injecting near periungual locations,” Dr. Ghali continued, noting that “it’s probably best practice to avoid subungual injections.”
Immunotherapy has relatively few side effects, and may be effective in about three-quarters of cases, according to Dr. Ghali, although he cautioned that younger children may be anxious about receiving injections and may resist treatment.
Electrodessication and curettage
For challenging warts, such as stubborn palmar or plantar warts, Dr. Ghali suggested using local anesthesia plus electrodessication and curettage.
“Sometimes with these refractory warts, we resort to off-label therapies compounded for home use,” he added. Such therapies may include salicylic acid with 5-fluorouracil, or topical cidofovir 2%-3%. These compounds can be costly depending upon the patient’s insurance coverage.
Dr. Ghali concluded by presenting his top three rules to consider when treating warts, regardless of treatment: There is no cure for warts, no therapy is uniformly effective, and the chosen therapy should take into account the family’s costs, according to their insurance coverage.
Since the landscape of insurance coverage has changed over recent years, the code most often used to treat warts in the office, often applies to the patient’s or family’s deductible. “It’s important to discuss this with the family beforehand, especially since treatment for warts may require several visits,” he said.
Dr. Ghali disclosed several financial relationships with the pharmaceutical industry including Astellas, Galderma, and Valeant, among others.
Global Academy and this news organization are owned by the same parent company.
[email protected]
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM THE CARIBBEAN DERMATOLOGY SYMPOSIUM
Interval cholecystectomy may be a risky business
HOLLYWOOD, FLA – Interval cholecystectomy remains a challenging procedure, with longer operative times and ICU stays, greater blood loss, more biliary and bowel injuries, and even hints of increased mortality, compared with immediate cholecystectomy, according to the findings from a retrospective study of 404 patients.
The staged procedure, completed after antibiotic therapy and percutaneous cholecystostomy, has been increasing in frequency over the past 10 years, but has not been rigorously studied, James Ackerman, MD, said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
“Looking at Medicare data over the past decade, we see a 50% increase in this procedure, which is marked by some striking regional variation,” from 5% of acute cholecystitis cases in the Northeast to less than 1% in some other regions. “This shows that as a group, we really don’t know what to do with this procedure.”
The revised Tokyo Guidelines for the management of acute cholangitis and cholecystitis aren’t hugely helpful either, noted Dr. Ackerman of the University of Pittsburgh Medical Center. While the guidelines are fairly straightforward for patients with grade 1 and grade 3 disease, “there’s a lot of gray area in grade 2.”
Treatment for these patients should include biliary drainage with antibiotics, but, he said, the recommendations for surgery, and whether it should be elective, immediate, or delayed, can be confusing for this group.
Dr. Ackerman’s retrospective analysis comprised 177 patients with acute cholecystitis who underwent an interval cholecystectomy (IC) after percutaneous cholecystostomy, and 227 controls who underwent an immediate cholecystectomy. The analysis spanned 2008-2013 and used data from seven hospitals in one health care system.
Patients who had the IC were older (70 vs. 55 years), had a worse American Society of Anesthesiologists class (3 vs. 2.5), and a worse Tokyo Grade (2 vs. 1).
Most of the IC procedures (119) were laparoscopic. There were 43 conversions to open and 15 were planned open surgeries. Among the immediate cholecystectomies, most (192) were laparoscopic. There were 28 conversions to open and six planned open surgeries.
The conversion rate was significantly higher among the IC group (28% vs.13%). The most common reasons for conversion were hostile abdomen (48% vs. 16%) and hostile right upper quadrant (34% vs. 58%).
Operating time was significantly longer in the IC group (121 vs. 90 minutes). Estimated blood loss was also significantly higher (30 vs. 15 cc). Total hospital stay was significantly longer (7 vs. 5 days), as was ICU stay (1 vs. 0.1 day).
There were no biliary tract injuries in the cholecystectomy group, while 5.7% of IC patients sustained such an injury. Bowel injuries, most often serosal, were also more common in the IC group (6% vs. 0.4%). The IC group had more surgical site infections as well (12% vs. 0.44%).
There was no significant difference in 30-day mortality, but at 1 year, IC patients were significantly more likely to have died (15% vs. 0.44%).
The ongoing CHOCOLATE trial (Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy) may help clarify the issue further, Dr. Ackerman said. The study being conducted in the Netherlands is randomizing high-risk cholecystitis patients to either laparoscopic cholecystectomy or percutaneous drainage.
Dr. Ackerman had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
HOLLYWOOD, FLA – Interval cholecystectomy remains a challenging procedure, with longer operative times and ICU stays, greater blood loss, more biliary and bowel injuries, and even hints of increased mortality, compared with immediate cholecystectomy, according to the findings from a retrospective study of 404 patients.
The staged procedure, completed after antibiotic therapy and percutaneous cholecystostomy, has been increasing in frequency over the past 10 years, but has not been rigorously studied, James Ackerman, MD, said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
“Looking at Medicare data over the past decade, we see a 50% increase in this procedure, which is marked by some striking regional variation,” from 5% of acute cholecystitis cases in the Northeast to less than 1% in some other regions. “This shows that as a group, we really don’t know what to do with this procedure.”
The revised Tokyo Guidelines for the management of acute cholangitis and cholecystitis aren’t hugely helpful either, noted Dr. Ackerman of the University of Pittsburgh Medical Center. While the guidelines are fairly straightforward for patients with grade 1 and grade 3 disease, “there’s a lot of gray area in grade 2.”
Treatment for these patients should include biliary drainage with antibiotics, but, he said, the recommendations for surgery, and whether it should be elective, immediate, or delayed, can be confusing for this group.
Dr. Ackerman’s retrospective analysis comprised 177 patients with acute cholecystitis who underwent an interval cholecystectomy (IC) after percutaneous cholecystostomy, and 227 controls who underwent an immediate cholecystectomy. The analysis spanned 2008-2013 and used data from seven hospitals in one health care system.
Patients who had the IC were older (70 vs. 55 years), had a worse American Society of Anesthesiologists class (3 vs. 2.5), and a worse Tokyo Grade (2 vs. 1).
Most of the IC procedures (119) were laparoscopic. There were 43 conversions to open and 15 were planned open surgeries. Among the immediate cholecystectomies, most (192) were laparoscopic. There were 28 conversions to open and six planned open surgeries.
The conversion rate was significantly higher among the IC group (28% vs.13%). The most common reasons for conversion were hostile abdomen (48% vs. 16%) and hostile right upper quadrant (34% vs. 58%).
Operating time was significantly longer in the IC group (121 vs. 90 minutes). Estimated blood loss was also significantly higher (30 vs. 15 cc). Total hospital stay was significantly longer (7 vs. 5 days), as was ICU stay (1 vs. 0.1 day).
There were no biliary tract injuries in the cholecystectomy group, while 5.7% of IC patients sustained such an injury. Bowel injuries, most often serosal, were also more common in the IC group (6% vs. 0.4%). The IC group had more surgical site infections as well (12% vs. 0.44%).
There was no significant difference in 30-day mortality, but at 1 year, IC patients were significantly more likely to have died (15% vs. 0.44%).
The ongoing CHOCOLATE trial (Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy) may help clarify the issue further, Dr. Ackerman said. The study being conducted in the Netherlands is randomizing high-risk cholecystitis patients to either laparoscopic cholecystectomy or percutaneous drainage.
Dr. Ackerman had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
HOLLYWOOD, FLA – Interval cholecystectomy remains a challenging procedure, with longer operative times and ICU stays, greater blood loss, more biliary and bowel injuries, and even hints of increased mortality, compared with immediate cholecystectomy, according to the findings from a retrospective study of 404 patients.
The staged procedure, completed after antibiotic therapy and percutaneous cholecystostomy, has been increasing in frequency over the past 10 years, but has not been rigorously studied, James Ackerman, MD, said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
“Looking at Medicare data over the past decade, we see a 50% increase in this procedure, which is marked by some striking regional variation,” from 5% of acute cholecystitis cases in the Northeast to less than 1% in some other regions. “This shows that as a group, we really don’t know what to do with this procedure.”
The revised Tokyo Guidelines for the management of acute cholangitis and cholecystitis aren’t hugely helpful either, noted Dr. Ackerman of the University of Pittsburgh Medical Center. While the guidelines are fairly straightforward for patients with grade 1 and grade 3 disease, “there’s a lot of gray area in grade 2.”
Treatment for these patients should include biliary drainage with antibiotics, but, he said, the recommendations for surgery, and whether it should be elective, immediate, or delayed, can be confusing for this group.
Dr. Ackerman’s retrospective analysis comprised 177 patients with acute cholecystitis who underwent an interval cholecystectomy (IC) after percutaneous cholecystostomy, and 227 controls who underwent an immediate cholecystectomy. The analysis spanned 2008-2013 and used data from seven hospitals in one health care system.
Patients who had the IC were older (70 vs. 55 years), had a worse American Society of Anesthesiologists class (3 vs. 2.5), and a worse Tokyo Grade (2 vs. 1).
Most of the IC procedures (119) were laparoscopic. There were 43 conversions to open and 15 were planned open surgeries. Among the immediate cholecystectomies, most (192) were laparoscopic. There were 28 conversions to open and six planned open surgeries.
The conversion rate was significantly higher among the IC group (28% vs.13%). The most common reasons for conversion were hostile abdomen (48% vs. 16%) and hostile right upper quadrant (34% vs. 58%).
Operating time was significantly longer in the IC group (121 vs. 90 minutes). Estimated blood loss was also significantly higher (30 vs. 15 cc). Total hospital stay was significantly longer (7 vs. 5 days), as was ICU stay (1 vs. 0.1 day).
There were no biliary tract injuries in the cholecystectomy group, while 5.7% of IC patients sustained such an injury. Bowel injuries, most often serosal, were also more common in the IC group (6% vs. 0.4%). The IC group had more surgical site infections as well (12% vs. 0.44%).
There was no significant difference in 30-day mortality, but at 1 year, IC patients were significantly more likely to have died (15% vs. 0.44%).
The ongoing CHOCOLATE trial (Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy) may help clarify the issue further, Dr. Ackerman said. The study being conducted in the Netherlands is randomizing high-risk cholecystitis patients to either laparoscopic cholecystectomy or percutaneous drainage.
Dr. Ackerman had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
AT THE EAST ANNUAL SCIENTIFIC ASSEMBLY
Key clinical point:
Major finding: Interval cholecystectomy was associated with greater blood loss, more conversions to open surgery, bowel and biliary injuries, and even higher 1-year mortality (15% vs. 0.44%).
Data source: A retrospective review comparing 177 patients with interval surgery to 227 who had immediate surgery.
Disclosures: Dr. Ackerman had no financial disclosures.
One GOP plan says states that like their Obamacare can keep it
Some states could keep their federally funded insurance exchange with consumer protections intact under a proposal unveiled Monday by two Republican U.S. senators.
Sen. Bill Cassidy (R-La.) and Sen. Susan Collins (R-Maine) said their proposed legislation would allow states that embraced the Affordable Care Act to keep operating under many of the current federal rules.
Another option is for states to pursue a less-regulated alternative to Obamacare under the Patient Freedom Act. Or they could reject federal dollars completely in favor of a new state solution for health coverage.
“We give states the option,” Sen. Cassidy said at press conference Jan. 23.
Some health law supporters say the Cassidy-Collins proposal, one of several in the GOP-controlled Congress, could represent a lifeline for states such as California that have invested heavily in expanding coverage under the ACA.
But many Democrats at the state and national level criticized the plan as potentially harmful to millions of Americans who rely on the health law because it does not promise sufficient funding and consumer protections.
“It provides a somewhat illusory option to stay in the ACA without the guarantee of federal assistance necessary to allow states to maintain the level of coverage they are currently providing,” California Insurance Commissioner Dave Jones, an elected Democrat, said in an interview.
California fully implemented the health law by expanding Medicaid coverage to millions of low-income people and creating its own insurance exchange, which ultimately covered 1.3 million enrollees. Supporters have held the state up as proof that the health law can work as intended – and as a counterpoint to Republican contentions that Obamacare is collapsing nationally.
Sen. Cassidy said his legislation promotes the Republican doctrine of states’ rights while avoiding the one-size-fits-all approach from Washington.
Sen. Collins echoed that sentiment, saying she favors letting states that had success with the health law maintain the status quo. She described it as “reimplementation of the ACA” in those states.
“If a state chooses to remain covered by the ACA, exchange policies will continue to be eligible for cost-sharing subsidies and advance premium tax credits,” she said in a Senate floor speech Jan. 23. “The insurance market will still be subject to ACA requirements, and the individual mandate and employer mandate will also remain in place in that state.”
Sen. Cassidy and Sen. Collins acknowledged that details of their bill haven’t been worked out, nor is it clear how it will mesh with other proposals. Competing plans in Congress don’t envision these state options, and it’s unclear what approach President Donald Trump and his nascent administration will take in crafting a replacement plan.
Still, some industry experts and analysts say the Cassidy-Collins proposal is intriguing.
“The advantage to a state like California is we could protect what we have accomplished already,” said Howard Kahn, former chief executive of L.A. Care Health Plan, an insurer on the Covered California exchange. The large managed care plan serves patients in Medi-Cal, the state’s Medicaid program.
“Cassidy’s proposal could work for California better than other alternatives in the short term. The question is whether they maintain federal funding for the longer term,” Mr. Kahn said. “My feeling is you do have to engage with the rational Republicans who are trying to find something that doesn’t tear it all apart.”
Federal funding is a key issue for states. In a summary of the bill posted by Sen. Collins, it said states choosing to retain Obamacare or pick the Republican alternative could receive “funding equal to 95% of federal premium tax credits and cost-sharing subsidies, as well as the federal match for Medicaid expansion.”
Dylan H. Roby, of the department of health services administration at the University of Maryland School of Public Health, College Park, said “California would still have to absorb a 5% cut, at least, in the premium tax credits and cost-sharing subsidies.”
Republicans will need 60 votes in the U.S. Senate to pass a full replacement for the ACA. Sen. Cassidy said his compromise approach is designed to win over some Democrats and reach that 60-vote majority.
In her speech on the Senate floor, Sen. Collins said children could still stay on their parents’ health plans until they are 26 years old. There would be no discrimination against preexisting conditions and no caps on annual or lifetime coverage, she said.
Other key features of the legislation include a provision allowing states to automatically enroll eligible people in health plans unless they opt out. The plan also promotes health savings accounts and price transparency requiring hospitals and other providers to disclose costs so consumers can shop around for the best price.
This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
Some states could keep their federally funded insurance exchange with consumer protections intact under a proposal unveiled Monday by two Republican U.S. senators.
Sen. Bill Cassidy (R-La.) and Sen. Susan Collins (R-Maine) said their proposed legislation would allow states that embraced the Affordable Care Act to keep operating under many of the current federal rules.
Another option is for states to pursue a less-regulated alternative to Obamacare under the Patient Freedom Act. Or they could reject federal dollars completely in favor of a new state solution for health coverage.
“We give states the option,” Sen. Cassidy said at press conference Jan. 23.
Some health law supporters say the Cassidy-Collins proposal, one of several in the GOP-controlled Congress, could represent a lifeline for states such as California that have invested heavily in expanding coverage under the ACA.
But many Democrats at the state and national level criticized the plan as potentially harmful to millions of Americans who rely on the health law because it does not promise sufficient funding and consumer protections.
“It provides a somewhat illusory option to stay in the ACA without the guarantee of federal assistance necessary to allow states to maintain the level of coverage they are currently providing,” California Insurance Commissioner Dave Jones, an elected Democrat, said in an interview.
California fully implemented the health law by expanding Medicaid coverage to millions of low-income people and creating its own insurance exchange, which ultimately covered 1.3 million enrollees. Supporters have held the state up as proof that the health law can work as intended – and as a counterpoint to Republican contentions that Obamacare is collapsing nationally.
Sen. Cassidy said his legislation promotes the Republican doctrine of states’ rights while avoiding the one-size-fits-all approach from Washington.
Sen. Collins echoed that sentiment, saying she favors letting states that had success with the health law maintain the status quo. She described it as “reimplementation of the ACA” in those states.
“If a state chooses to remain covered by the ACA, exchange policies will continue to be eligible for cost-sharing subsidies and advance premium tax credits,” she said in a Senate floor speech Jan. 23. “The insurance market will still be subject to ACA requirements, and the individual mandate and employer mandate will also remain in place in that state.”
Sen. Cassidy and Sen. Collins acknowledged that details of their bill haven’t been worked out, nor is it clear how it will mesh with other proposals. Competing plans in Congress don’t envision these state options, and it’s unclear what approach President Donald Trump and his nascent administration will take in crafting a replacement plan.
Still, some industry experts and analysts say the Cassidy-Collins proposal is intriguing.
“The advantage to a state like California is we could protect what we have accomplished already,” said Howard Kahn, former chief executive of L.A. Care Health Plan, an insurer on the Covered California exchange. The large managed care plan serves patients in Medi-Cal, the state’s Medicaid program.
“Cassidy’s proposal could work for California better than other alternatives in the short term. The question is whether they maintain federal funding for the longer term,” Mr. Kahn said. “My feeling is you do have to engage with the rational Republicans who are trying to find something that doesn’t tear it all apart.”
Federal funding is a key issue for states. In a summary of the bill posted by Sen. Collins, it said states choosing to retain Obamacare or pick the Republican alternative could receive “funding equal to 95% of federal premium tax credits and cost-sharing subsidies, as well as the federal match for Medicaid expansion.”
Dylan H. Roby, of the department of health services administration at the University of Maryland School of Public Health, College Park, said “California would still have to absorb a 5% cut, at least, in the premium tax credits and cost-sharing subsidies.”
Republicans will need 60 votes in the U.S. Senate to pass a full replacement for the ACA. Sen. Cassidy said his compromise approach is designed to win over some Democrats and reach that 60-vote majority.
In her speech on the Senate floor, Sen. Collins said children could still stay on their parents’ health plans until they are 26 years old. There would be no discrimination against preexisting conditions and no caps on annual or lifetime coverage, she said.
Other key features of the legislation include a provision allowing states to automatically enroll eligible people in health plans unless they opt out. The plan also promotes health savings accounts and price transparency requiring hospitals and other providers to disclose costs so consumers can shop around for the best price.
This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
Some states could keep their federally funded insurance exchange with consumer protections intact under a proposal unveiled Monday by two Republican U.S. senators.
Sen. Bill Cassidy (R-La.) and Sen. Susan Collins (R-Maine) said their proposed legislation would allow states that embraced the Affordable Care Act to keep operating under many of the current federal rules.
Another option is for states to pursue a less-regulated alternative to Obamacare under the Patient Freedom Act. Or they could reject federal dollars completely in favor of a new state solution for health coverage.
“We give states the option,” Sen. Cassidy said at press conference Jan. 23.
Some health law supporters say the Cassidy-Collins proposal, one of several in the GOP-controlled Congress, could represent a lifeline for states such as California that have invested heavily in expanding coverage under the ACA.
But many Democrats at the state and national level criticized the plan as potentially harmful to millions of Americans who rely on the health law because it does not promise sufficient funding and consumer protections.
“It provides a somewhat illusory option to stay in the ACA without the guarantee of federal assistance necessary to allow states to maintain the level of coverage they are currently providing,” California Insurance Commissioner Dave Jones, an elected Democrat, said in an interview.
California fully implemented the health law by expanding Medicaid coverage to millions of low-income people and creating its own insurance exchange, which ultimately covered 1.3 million enrollees. Supporters have held the state up as proof that the health law can work as intended – and as a counterpoint to Republican contentions that Obamacare is collapsing nationally.
Sen. Cassidy said his legislation promotes the Republican doctrine of states’ rights while avoiding the one-size-fits-all approach from Washington.
Sen. Collins echoed that sentiment, saying she favors letting states that had success with the health law maintain the status quo. She described it as “reimplementation of the ACA” in those states.
“If a state chooses to remain covered by the ACA, exchange policies will continue to be eligible for cost-sharing subsidies and advance premium tax credits,” she said in a Senate floor speech Jan. 23. “The insurance market will still be subject to ACA requirements, and the individual mandate and employer mandate will also remain in place in that state.”
Sen. Cassidy and Sen. Collins acknowledged that details of their bill haven’t been worked out, nor is it clear how it will mesh with other proposals. Competing plans in Congress don’t envision these state options, and it’s unclear what approach President Donald Trump and his nascent administration will take in crafting a replacement plan.
Still, some industry experts and analysts say the Cassidy-Collins proposal is intriguing.
“The advantage to a state like California is we could protect what we have accomplished already,” said Howard Kahn, former chief executive of L.A. Care Health Plan, an insurer on the Covered California exchange. The large managed care plan serves patients in Medi-Cal, the state’s Medicaid program.
“Cassidy’s proposal could work for California better than other alternatives in the short term. The question is whether they maintain federal funding for the longer term,” Mr. Kahn said. “My feeling is you do have to engage with the rational Republicans who are trying to find something that doesn’t tear it all apart.”
Federal funding is a key issue for states. In a summary of the bill posted by Sen. Collins, it said states choosing to retain Obamacare or pick the Republican alternative could receive “funding equal to 95% of federal premium tax credits and cost-sharing subsidies, as well as the federal match for Medicaid expansion.”
Dylan H. Roby, of the department of health services administration at the University of Maryland School of Public Health, College Park, said “California would still have to absorb a 5% cut, at least, in the premium tax credits and cost-sharing subsidies.”
Republicans will need 60 votes in the U.S. Senate to pass a full replacement for the ACA. Sen. Cassidy said his compromise approach is designed to win over some Democrats and reach that 60-vote majority.
In her speech on the Senate floor, Sen. Collins said children could still stay on their parents’ health plans until they are 26 years old. There would be no discrimination against preexisting conditions and no caps on annual or lifetime coverage, she said.
Other key features of the legislation include a provision allowing states to automatically enroll eligible people in health plans unless they opt out. The plan also promotes health savings accounts and price transparency requiring hospitals and other providers to disclose costs so consumers can shop around for the best price.
This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
ECT tied to better responses in late-onset depression in older patients
Older patients with late-onset treatment-resistant depression and psychotic symptoms appear to get better results from electroconvulsive therapy than those with early-onset depression and fewer psychotic symptoms, a longitudinal study of 110 patients suggests.
“Our results indicate that [electroconvulsive therapy] is very effective even in pharmacotherapy-resistant [late-life depression] with vascular burden,” wrote Annemiek Dols, MD, PhD, Filip Bouckaert, MD, and associates.
The investigators recruited severely depressed patients who were receiving electroconvulsive therapy (ECT) from psychiatric hospitals in Amsterdam and Leuven, Belgium, as part of the Mood Disorders in Elderly Treated with Electroconvulsive Therapy (MODECT) study between January 2011 and December 2013.
They defined early-onset depression as a first depressive episode experienced by patients before age 55 years. Late-onset depression was defined as a first depressive episode that occurred at age 55 and older, reported Dr. Dols of the department of old age psychiatry at GGZ inGeest in Amsterdam and Dr. Bouckaert of the department of radiology and nuclear medicine at VU University Medical Center, also in Amsterdam.
The average age of the 110 patients was 73 years, and 72 were women. Patients with diagnoses of bipolar and schizoaffective disorder were excluded, as were patients with a history of neurologic illnesses such as Parkinson’s disease, stroke, or dementia.
Dr. Dols, Dr. Bouckaert, and associates measured the patients’ cognition using several instruments, including the 30-point Mini-Mental State Examination (MMSE) before, during, and after 1 week of a course of ECT. A response was defined as an improvement of 50% or more in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline during an ECT course. Remission was defined as a MADRS score below 10 points after ECT (Am J Geriatr Psychiatry. 2017 Feb;25[2]:178-89).
Mean MMSE scores climbed from 24.5 before ECT to 27.25 for the early-onset depression patients, compared with 24.04 to 25.39 for the late-onset depression patients. Overall, the investigators reported, patients with late-onset depression had a response rate of 86.9%, compared with a response rate of 67.3% for those with early-onset depression after receiving a similar number of ECT sessions.
However, the higher response rates in late-onset depression could not be explained by “clinical or structural brain characteristics,” the investigators noted. “The number of responders with [late-onset depression] was probably too low (n = 8) to find statistically significant associations.”
To read more about the study, click here.
[email protected]
On Twitter @ginalhenderson
Older patients with late-onset treatment-resistant depression and psychotic symptoms appear to get better results from electroconvulsive therapy than those with early-onset depression and fewer psychotic symptoms, a longitudinal study of 110 patients suggests.
“Our results indicate that [electroconvulsive therapy] is very effective even in pharmacotherapy-resistant [late-life depression] with vascular burden,” wrote Annemiek Dols, MD, PhD, Filip Bouckaert, MD, and associates.
The investigators recruited severely depressed patients who were receiving electroconvulsive therapy (ECT) from psychiatric hospitals in Amsterdam and Leuven, Belgium, as part of the Mood Disorders in Elderly Treated with Electroconvulsive Therapy (MODECT) study between January 2011 and December 2013.
They defined early-onset depression as a first depressive episode experienced by patients before age 55 years. Late-onset depression was defined as a first depressive episode that occurred at age 55 and older, reported Dr. Dols of the department of old age psychiatry at GGZ inGeest in Amsterdam and Dr. Bouckaert of the department of radiology and nuclear medicine at VU University Medical Center, also in Amsterdam.
The average age of the 110 patients was 73 years, and 72 were women. Patients with diagnoses of bipolar and schizoaffective disorder were excluded, as were patients with a history of neurologic illnesses such as Parkinson’s disease, stroke, or dementia.
Dr. Dols, Dr. Bouckaert, and associates measured the patients’ cognition using several instruments, including the 30-point Mini-Mental State Examination (MMSE) before, during, and after 1 week of a course of ECT. A response was defined as an improvement of 50% or more in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline during an ECT course. Remission was defined as a MADRS score below 10 points after ECT (Am J Geriatr Psychiatry. 2017 Feb;25[2]:178-89).
Mean MMSE scores climbed from 24.5 before ECT to 27.25 for the early-onset depression patients, compared with 24.04 to 25.39 for the late-onset depression patients. Overall, the investigators reported, patients with late-onset depression had a response rate of 86.9%, compared with a response rate of 67.3% for those with early-onset depression after receiving a similar number of ECT sessions.
However, the higher response rates in late-onset depression could not be explained by “clinical or structural brain characteristics,” the investigators noted. “The number of responders with [late-onset depression] was probably too low (n = 8) to find statistically significant associations.”
To read more about the study, click here.
[email protected]
On Twitter @ginalhenderson
Older patients with late-onset treatment-resistant depression and psychotic symptoms appear to get better results from electroconvulsive therapy than those with early-onset depression and fewer psychotic symptoms, a longitudinal study of 110 patients suggests.
“Our results indicate that [electroconvulsive therapy] is very effective even in pharmacotherapy-resistant [late-life depression] with vascular burden,” wrote Annemiek Dols, MD, PhD, Filip Bouckaert, MD, and associates.
The investigators recruited severely depressed patients who were receiving electroconvulsive therapy (ECT) from psychiatric hospitals in Amsterdam and Leuven, Belgium, as part of the Mood Disorders in Elderly Treated with Electroconvulsive Therapy (MODECT) study between January 2011 and December 2013.
They defined early-onset depression as a first depressive episode experienced by patients before age 55 years. Late-onset depression was defined as a first depressive episode that occurred at age 55 and older, reported Dr. Dols of the department of old age psychiatry at GGZ inGeest in Amsterdam and Dr. Bouckaert of the department of radiology and nuclear medicine at VU University Medical Center, also in Amsterdam.
The average age of the 110 patients was 73 years, and 72 were women. Patients with diagnoses of bipolar and schizoaffective disorder were excluded, as were patients with a history of neurologic illnesses such as Parkinson’s disease, stroke, or dementia.
Dr. Dols, Dr. Bouckaert, and associates measured the patients’ cognition using several instruments, including the 30-point Mini-Mental State Examination (MMSE) before, during, and after 1 week of a course of ECT. A response was defined as an improvement of 50% or more in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline during an ECT course. Remission was defined as a MADRS score below 10 points after ECT (Am J Geriatr Psychiatry. 2017 Feb;25[2]:178-89).
Mean MMSE scores climbed from 24.5 before ECT to 27.25 for the early-onset depression patients, compared with 24.04 to 25.39 for the late-onset depression patients. Overall, the investigators reported, patients with late-onset depression had a response rate of 86.9%, compared with a response rate of 67.3% for those with early-onset depression after receiving a similar number of ECT sessions.
However, the higher response rates in late-onset depression could not be explained by “clinical or structural brain characteristics,” the investigators noted. “The number of responders with [late-onset depression] was probably too low (n = 8) to find statistically significant associations.”
To read more about the study, click here.
[email protected]
On Twitter @ginalhenderson
FROM THE AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY
Strokes, migraines linked in women with possible CAD
NEW ORLEANS – Women who underwent a clinically indicated coronary angiogram and also reported having migraine headaches had a twofold increased rate of strokes, compared with similar women without a history of migraine, in a prospective, observational study of 888 women followed for a median of 6.5 years.
This finding “underscores that more attention should be placed on evaluating women with a history of migraine headache for cardiovascular disease,” Cecil A. Rambarat, MD, said at the American Heart Association scientific sessions.
Aspirin aside, what’s important for these women is to “modify their risk factors and look at their family history,” reported Dr Rambarat of the University of Florida in Gainesville.
The study used data collected on women enrolled in the Women’s Ischemic Syndrome Evaluation (WISE) study during 1996-1999. WISE entered women at four U.S. centers scheduled for a clinically indicated coronary angiogram as part of their routine care for chest pain symptoms or suspected myocardial ischemia.
Among the 936 women enrolled in WISE, 917 completed a baseline questionnaire about their migraine history that showed 224 women had a migraine history and 693 women did not report having migraine headaches. The average age of women with a migraine history was 54 years, compared with 59 years in those without migraines.
All 917 women were followed for a median of 6.5 years for the incidence of nonfatal myocardial infarction, stroke, or heart failure. A subgroup of 888 of these women were also followed for a median of 9.5 years for mortality, including the incidence of cardiovascular death.
After the investigators adjusted for age, race, body mass index, history of diabetes or hypertension, dyslipidemia, smoking, and other variables, women with migraine were 83% more likely to have a cardiovascular event (cardiovascular death or nonfatal event) during follow-up, compared with women with no migraine history, a statistically significant difference.
Women with migraine were also 2.33-fold more likely to have a nonfatal stroke during follow-up, also a statistically significant difference. The increased stroke rate seems to have largely driven the significant difference in all cardiovascular events.
The mechanisms that might link migraine headaches with stroke are not clear, but Dr. Rambarat suggested several possibilities. Women with migraine may have dysfunction of their vascular endothelium, increased inflammatory markers, increased release of prothrombotic factors, a patent foramen ovale, or certain genetic risk factors that predispose them to migraine and to stroke or other cardiovascular disease, he said.
A report of these findings was recently published online (Am J Med. 2016 Dec 28. doi: 10.1016/j.amjmed.2016.12.028).
Dr. Rambarat had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
NEW ORLEANS – Women who underwent a clinically indicated coronary angiogram and also reported having migraine headaches had a twofold increased rate of strokes, compared with similar women without a history of migraine, in a prospective, observational study of 888 women followed for a median of 6.5 years.
This finding “underscores that more attention should be placed on evaluating women with a history of migraine headache for cardiovascular disease,” Cecil A. Rambarat, MD, said at the American Heart Association scientific sessions.
Aspirin aside, what’s important for these women is to “modify their risk factors and look at their family history,” reported Dr Rambarat of the University of Florida in Gainesville.
The study used data collected on women enrolled in the Women’s Ischemic Syndrome Evaluation (WISE) study during 1996-1999. WISE entered women at four U.S. centers scheduled for a clinically indicated coronary angiogram as part of their routine care for chest pain symptoms or suspected myocardial ischemia.
Among the 936 women enrolled in WISE, 917 completed a baseline questionnaire about their migraine history that showed 224 women had a migraine history and 693 women did not report having migraine headaches. The average age of women with a migraine history was 54 years, compared with 59 years in those without migraines.
All 917 women were followed for a median of 6.5 years for the incidence of nonfatal myocardial infarction, stroke, or heart failure. A subgroup of 888 of these women were also followed for a median of 9.5 years for mortality, including the incidence of cardiovascular death.
After the investigators adjusted for age, race, body mass index, history of diabetes or hypertension, dyslipidemia, smoking, and other variables, women with migraine were 83% more likely to have a cardiovascular event (cardiovascular death or nonfatal event) during follow-up, compared with women with no migraine history, a statistically significant difference.
Women with migraine were also 2.33-fold more likely to have a nonfatal stroke during follow-up, also a statistically significant difference. The increased stroke rate seems to have largely driven the significant difference in all cardiovascular events.
The mechanisms that might link migraine headaches with stroke are not clear, but Dr. Rambarat suggested several possibilities. Women with migraine may have dysfunction of their vascular endothelium, increased inflammatory markers, increased release of prothrombotic factors, a patent foramen ovale, or certain genetic risk factors that predispose them to migraine and to stroke or other cardiovascular disease, he said.
A report of these findings was recently published online (Am J Med. 2016 Dec 28. doi: 10.1016/j.amjmed.2016.12.028).
Dr. Rambarat had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
NEW ORLEANS – Women who underwent a clinically indicated coronary angiogram and also reported having migraine headaches had a twofold increased rate of strokes, compared with similar women without a history of migraine, in a prospective, observational study of 888 women followed for a median of 6.5 years.
This finding “underscores that more attention should be placed on evaluating women with a history of migraine headache for cardiovascular disease,” Cecil A. Rambarat, MD, said at the American Heart Association scientific sessions.
Aspirin aside, what’s important for these women is to “modify their risk factors and look at their family history,” reported Dr Rambarat of the University of Florida in Gainesville.
The study used data collected on women enrolled in the Women’s Ischemic Syndrome Evaluation (WISE) study during 1996-1999. WISE entered women at four U.S. centers scheduled for a clinically indicated coronary angiogram as part of their routine care for chest pain symptoms or suspected myocardial ischemia.
Among the 936 women enrolled in WISE, 917 completed a baseline questionnaire about their migraine history that showed 224 women had a migraine history and 693 women did not report having migraine headaches. The average age of women with a migraine history was 54 years, compared with 59 years in those without migraines.
All 917 women were followed for a median of 6.5 years for the incidence of nonfatal myocardial infarction, stroke, or heart failure. A subgroup of 888 of these women were also followed for a median of 9.5 years for mortality, including the incidence of cardiovascular death.
After the investigators adjusted for age, race, body mass index, history of diabetes or hypertension, dyslipidemia, smoking, and other variables, women with migraine were 83% more likely to have a cardiovascular event (cardiovascular death or nonfatal event) during follow-up, compared with women with no migraine history, a statistically significant difference.
Women with migraine were also 2.33-fold more likely to have a nonfatal stroke during follow-up, also a statistically significant difference. The increased stroke rate seems to have largely driven the significant difference in all cardiovascular events.
The mechanisms that might link migraine headaches with stroke are not clear, but Dr. Rambarat suggested several possibilities. Women with migraine may have dysfunction of their vascular endothelium, increased inflammatory markers, increased release of prothrombotic factors, a patent foramen ovale, or certain genetic risk factors that predispose them to migraine and to stroke or other cardiovascular disease, he said.
A report of these findings was recently published online (Am J Med. 2016 Dec 28. doi: 10.1016/j.amjmed.2016.12.028).
Dr. Rambarat had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: The stroke rate during 6.5 years of follow-up was more than twofold greater in women with a migraine headache history.
Data source: WISE, a study of 936 U.S. women enrolled during 1996-1999 and followed prospectively.
Disclosures: Dr. Rambarat had no relevant financial disclosures.
FDA approves Trulance for chronic idiopathic constipation
Trulance, a once-daily oral medication for chronic idiopathic constipation, has been approved by the Food and Drug Administration for adult patients as of Jan. 19.
Manufactured by Synergy Pharmaceuticals, Trulance (plecanatide) stimulates intestinal fluid secretion in the upper GI tract. Its efficacy and safety were determined to be sufficient in two 12-week placebo-controlled trials (NCT01982240 and NCT02122471). Participants taking Trulance were more likely than were those taking placebo to have improved bowel function and stool.
The FDA’s statement noted that “an estimated 42 million people are affected by constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and for whom there is no structural or biochemical explanation.”
Trulance, a once-daily oral medication for chronic idiopathic constipation, has been approved by the Food and Drug Administration for adult patients as of Jan. 19.
Manufactured by Synergy Pharmaceuticals, Trulance (plecanatide) stimulates intestinal fluid secretion in the upper GI tract. Its efficacy and safety were determined to be sufficient in two 12-week placebo-controlled trials (NCT01982240 and NCT02122471). Participants taking Trulance were more likely than were those taking placebo to have improved bowel function and stool.
The FDA’s statement noted that “an estimated 42 million people are affected by constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and for whom there is no structural or biochemical explanation.”
Trulance, a once-daily oral medication for chronic idiopathic constipation, has been approved by the Food and Drug Administration for adult patients as of Jan. 19.
Manufactured by Synergy Pharmaceuticals, Trulance (plecanatide) stimulates intestinal fluid secretion in the upper GI tract. Its efficacy and safety were determined to be sufficient in two 12-week placebo-controlled trials (NCT01982240 and NCT02122471). Participants taking Trulance were more likely than were those taking placebo to have improved bowel function and stool.
The FDA’s statement noted that “an estimated 42 million people are affected by constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and for whom there is no structural or biochemical explanation.”
Climate change: A call to action for psychiatry
In a recent survey of about 90 psychiatrists attending a national general psychiatry meeting, the overwhelming majority believed that climate change is human caused and the impacts were already or would soon be harming their patients. They expressed an interest in knowing more, reporting that they sometimes had little knowledge about the issues. They also believed that psychiatrists have a role to play in making the case to be better prepared for what our communities are facing. Professional organizations were a desirable choice as a source of information and training.
Because of these responses we, the Climate Psychiatry Alliance, believe that a scientific and well thought out program addressing the mental health impacts of climate disruption with practical advice on how to help our patients and our communities in the face of climate disasters while emphasizing preparedness and prevention, is called for.
As physicians, we are keenly aware of and concerned about the physical harm of extreme weather events causing acute harm, including tornadoes, fires, floods, hurricanes, and so on. We also know about the longer-term chronic conditions, including sea level rise, drought, and permanent and high temperatures.
We also know that the spread of infectious diseases, both old and some new, on us, our children, and even the unborn, is a rising challenge to our communities. The National Academy of Sciences, for example, recently linked the Zika outbreak to a rise in temperature (Proc Nat Acad Sci. 2017;114[1]:119-24). The expanding reach of malaria and the growing incidence of such illnesses as dengue, chikungunya, and Lyme also are linked to higher temperatures.
Though the physical harm from climate disruption is increasingly being discussed, more attention needs to be given to the psychological harm: When the place we call home is burned down, blown away, flooded … when we lose our possessions; maybe our pets, our livelihood; see injuries, illness, and death; the mix of fear, anger, sorrow, and trauma can bring on a full range of psychiatric disorders. Mental health professionals are already seeing posttraumatic stress disorder, depression, and anxiety disorders, as well as an increase in drug and alcohol abuse, violence against women, and child abuse (Ann Glob Health. 2014 Jul-Aug;80[4]:332-44), (Soc Sci Med. 2015;[141]:133-41), (Soc Sci Res. 2013;42[5]:1222-35), (Soc Sci Med. 2017 Jan 6;[175]:161-8).
The link between climate and aggression is clear: For each standard deviation of increased temperature and rainfall, a 4% rise in aggression between individuals and a 14% rise among groups can be expected (Science. 2013 Sep 13;34[6151]:1235367). This is true across all ethnicities and regions. General unrest around the world should come as no surprise to us – nor should its rise in the years ahead, given that temperatures will continue to rise.
The psychological needs and impacts on our communities of exploding numbers of refugees from mounting climate disruption in many areas of the world are of grave concern as the impacts of the upheaval grow ever more profound. The United Nations reports that what we are seeing now and are already unable to address, is just the tip of the iceberg.
Psychiatrists have a special role to play in all of this, because we not only are experts in physical health, we are experts on psychological harm.
We also know that any physical condition or illness carries an attendant emotional toll. Trained in science, we respect the scientific method and the peer-reviewed work that goes into validating what the scientists are telling us.
We know that harm that is entirely accidental is much easier to get over than harm experienced as avoidable. That appropriate action to protect our climate was not taken in time will become more apparent – with fear and anger among patients, families, and communities directed at policy makers and a compounding erosion of trust in our institutions. We must look at how fear, anger, and mistrust drive politics not only in our country but elsewhere since we are now a global village, interconnected.
And we must confront our values: Climate disruption is an issue of social justice, because those who will be hurt the most are from disadvantaged communities, and it is an intergenerational justice issue, because our children will inherit our mistakes. How will we answer these questions?
As experts focused on changing behaviors before it is too late, at confronting denial and resistance in ways that build people up and help influence them to change, and with the standing we have in the community, as psychiatrists we have a unique role to play. We also take seriously that our canon of ethics states our responsibility to serve our communities in ways that enhance their health.
We call upon our professional communities to help us respond to the growing public health crises. Among the many needs: education – putting together trainings for our colleagues and other thought leaders and policy makers that identify the public health burdens and drive action on them; preparedness – advising communities and individuals about how to deal with climate challenges; and prevention – advocating for solutions that reduce our vulnerability with sustainable habits and promote resilience. There is much more for us to uncover and act upon together in the months ahead.
We call upon one another for action, because only collective success will restore our health and keep us safe.
Dr. Van Susteren wrote this commentary on behalf of the Climate Psychiatry Alliance, a professional group dedicated to promoting awareness and action on climate from a mental health perspective. She is a practicing general and forensic psychiatrist in Washington. Dr. Van Susteren serves on the advisory board of the Center for Health and the Global Environment at Harvard T.H. Chan School of Public Health, Boston. She is a former member of the board of directors of the National Wildlife Federation and coauthor of group’s report, “The Psychological Effects of Global Warming on the United States – Why the U.S. Mental Health System is Not Prepared.” In 2006, Dr. Van Susteren sought the Democratic nomination for a U.S. Senate seat in Maryland. Recently, she founded Lucky Planet Foods, a company that provides plant-based, low carbon foods.
In a recent survey of about 90 psychiatrists attending a national general psychiatry meeting, the overwhelming majority believed that climate change is human caused and the impacts were already or would soon be harming their patients. They expressed an interest in knowing more, reporting that they sometimes had little knowledge about the issues. They also believed that psychiatrists have a role to play in making the case to be better prepared for what our communities are facing. Professional organizations were a desirable choice as a source of information and training.
Because of these responses we, the Climate Psychiatry Alliance, believe that a scientific and well thought out program addressing the mental health impacts of climate disruption with practical advice on how to help our patients and our communities in the face of climate disasters while emphasizing preparedness and prevention, is called for.
As physicians, we are keenly aware of and concerned about the physical harm of extreme weather events causing acute harm, including tornadoes, fires, floods, hurricanes, and so on. We also know about the longer-term chronic conditions, including sea level rise, drought, and permanent and high temperatures.
We also know that the spread of infectious diseases, both old and some new, on us, our children, and even the unborn, is a rising challenge to our communities. The National Academy of Sciences, for example, recently linked the Zika outbreak to a rise in temperature (Proc Nat Acad Sci. 2017;114[1]:119-24). The expanding reach of malaria and the growing incidence of such illnesses as dengue, chikungunya, and Lyme also are linked to higher temperatures.
Though the physical harm from climate disruption is increasingly being discussed, more attention needs to be given to the psychological harm: When the place we call home is burned down, blown away, flooded … when we lose our possessions; maybe our pets, our livelihood; see injuries, illness, and death; the mix of fear, anger, sorrow, and trauma can bring on a full range of psychiatric disorders. Mental health professionals are already seeing posttraumatic stress disorder, depression, and anxiety disorders, as well as an increase in drug and alcohol abuse, violence against women, and child abuse (Ann Glob Health. 2014 Jul-Aug;80[4]:332-44), (Soc Sci Med. 2015;[141]:133-41), (Soc Sci Res. 2013;42[5]:1222-35), (Soc Sci Med. 2017 Jan 6;[175]:161-8).
The link between climate and aggression is clear: For each standard deviation of increased temperature and rainfall, a 4% rise in aggression between individuals and a 14% rise among groups can be expected (Science. 2013 Sep 13;34[6151]:1235367). This is true across all ethnicities and regions. General unrest around the world should come as no surprise to us – nor should its rise in the years ahead, given that temperatures will continue to rise.
The psychological needs and impacts on our communities of exploding numbers of refugees from mounting climate disruption in many areas of the world are of grave concern as the impacts of the upheaval grow ever more profound. The United Nations reports that what we are seeing now and are already unable to address, is just the tip of the iceberg.
Psychiatrists have a special role to play in all of this, because we not only are experts in physical health, we are experts on psychological harm.
We also know that any physical condition or illness carries an attendant emotional toll. Trained in science, we respect the scientific method and the peer-reviewed work that goes into validating what the scientists are telling us.
We know that harm that is entirely accidental is much easier to get over than harm experienced as avoidable. That appropriate action to protect our climate was not taken in time will become more apparent – with fear and anger among patients, families, and communities directed at policy makers and a compounding erosion of trust in our institutions. We must look at how fear, anger, and mistrust drive politics not only in our country but elsewhere since we are now a global village, interconnected.
And we must confront our values: Climate disruption is an issue of social justice, because those who will be hurt the most are from disadvantaged communities, and it is an intergenerational justice issue, because our children will inherit our mistakes. How will we answer these questions?
As experts focused on changing behaviors before it is too late, at confronting denial and resistance in ways that build people up and help influence them to change, and with the standing we have in the community, as psychiatrists we have a unique role to play. We also take seriously that our canon of ethics states our responsibility to serve our communities in ways that enhance their health.
We call upon our professional communities to help us respond to the growing public health crises. Among the many needs: education – putting together trainings for our colleagues and other thought leaders and policy makers that identify the public health burdens and drive action on them; preparedness – advising communities and individuals about how to deal with climate challenges; and prevention – advocating for solutions that reduce our vulnerability with sustainable habits and promote resilience. There is much more for us to uncover and act upon together in the months ahead.
We call upon one another for action, because only collective success will restore our health and keep us safe.
Dr. Van Susteren wrote this commentary on behalf of the Climate Psychiatry Alliance, a professional group dedicated to promoting awareness and action on climate from a mental health perspective. She is a practicing general and forensic psychiatrist in Washington. Dr. Van Susteren serves on the advisory board of the Center for Health and the Global Environment at Harvard T.H. Chan School of Public Health, Boston. She is a former member of the board of directors of the National Wildlife Federation and coauthor of group’s report, “The Psychological Effects of Global Warming on the United States – Why the U.S. Mental Health System is Not Prepared.” In 2006, Dr. Van Susteren sought the Democratic nomination for a U.S. Senate seat in Maryland. Recently, she founded Lucky Planet Foods, a company that provides plant-based, low carbon foods.
In a recent survey of about 90 psychiatrists attending a national general psychiatry meeting, the overwhelming majority believed that climate change is human caused and the impacts were already or would soon be harming their patients. They expressed an interest in knowing more, reporting that they sometimes had little knowledge about the issues. They also believed that psychiatrists have a role to play in making the case to be better prepared for what our communities are facing. Professional organizations were a desirable choice as a source of information and training.
Because of these responses we, the Climate Psychiatry Alliance, believe that a scientific and well thought out program addressing the mental health impacts of climate disruption with practical advice on how to help our patients and our communities in the face of climate disasters while emphasizing preparedness and prevention, is called for.
As physicians, we are keenly aware of and concerned about the physical harm of extreme weather events causing acute harm, including tornadoes, fires, floods, hurricanes, and so on. We also know about the longer-term chronic conditions, including sea level rise, drought, and permanent and high temperatures.
We also know that the spread of infectious diseases, both old and some new, on us, our children, and even the unborn, is a rising challenge to our communities. The National Academy of Sciences, for example, recently linked the Zika outbreak to a rise in temperature (Proc Nat Acad Sci. 2017;114[1]:119-24). The expanding reach of malaria and the growing incidence of such illnesses as dengue, chikungunya, and Lyme also are linked to higher temperatures.
Though the physical harm from climate disruption is increasingly being discussed, more attention needs to be given to the psychological harm: When the place we call home is burned down, blown away, flooded … when we lose our possessions; maybe our pets, our livelihood; see injuries, illness, and death; the mix of fear, anger, sorrow, and trauma can bring on a full range of psychiatric disorders. Mental health professionals are already seeing posttraumatic stress disorder, depression, and anxiety disorders, as well as an increase in drug and alcohol abuse, violence against women, and child abuse (Ann Glob Health. 2014 Jul-Aug;80[4]:332-44), (Soc Sci Med. 2015;[141]:133-41), (Soc Sci Res. 2013;42[5]:1222-35), (Soc Sci Med. 2017 Jan 6;[175]:161-8).
The link between climate and aggression is clear: For each standard deviation of increased temperature and rainfall, a 4% rise in aggression between individuals and a 14% rise among groups can be expected (Science. 2013 Sep 13;34[6151]:1235367). This is true across all ethnicities and regions. General unrest around the world should come as no surprise to us – nor should its rise in the years ahead, given that temperatures will continue to rise.
The psychological needs and impacts on our communities of exploding numbers of refugees from mounting climate disruption in many areas of the world are of grave concern as the impacts of the upheaval grow ever more profound. The United Nations reports that what we are seeing now and are already unable to address, is just the tip of the iceberg.
Psychiatrists have a special role to play in all of this, because we not only are experts in physical health, we are experts on psychological harm.
We also know that any physical condition or illness carries an attendant emotional toll. Trained in science, we respect the scientific method and the peer-reviewed work that goes into validating what the scientists are telling us.
We know that harm that is entirely accidental is much easier to get over than harm experienced as avoidable. That appropriate action to protect our climate was not taken in time will become more apparent – with fear and anger among patients, families, and communities directed at policy makers and a compounding erosion of trust in our institutions. We must look at how fear, anger, and mistrust drive politics not only in our country but elsewhere since we are now a global village, interconnected.
And we must confront our values: Climate disruption is an issue of social justice, because those who will be hurt the most are from disadvantaged communities, and it is an intergenerational justice issue, because our children will inherit our mistakes. How will we answer these questions?
As experts focused on changing behaviors before it is too late, at confronting denial and resistance in ways that build people up and help influence them to change, and with the standing we have in the community, as psychiatrists we have a unique role to play. We also take seriously that our canon of ethics states our responsibility to serve our communities in ways that enhance their health.
We call upon our professional communities to help us respond to the growing public health crises. Among the many needs: education – putting together trainings for our colleagues and other thought leaders and policy makers that identify the public health burdens and drive action on them; preparedness – advising communities and individuals about how to deal with climate challenges; and prevention – advocating for solutions that reduce our vulnerability with sustainable habits and promote resilience. There is much more for us to uncover and act upon together in the months ahead.
We call upon one another for action, because only collective success will restore our health and keep us safe.
Dr. Van Susteren wrote this commentary on behalf of the Climate Psychiatry Alliance, a professional group dedicated to promoting awareness and action on climate from a mental health perspective. She is a practicing general and forensic psychiatrist in Washington. Dr. Van Susteren serves on the advisory board of the Center for Health and the Global Environment at Harvard T.H. Chan School of Public Health, Boston. She is a former member of the board of directors of the National Wildlife Federation and coauthor of group’s report, “The Psychological Effects of Global Warming on the United States – Why the U.S. Mental Health System is Not Prepared.” In 2006, Dr. Van Susteren sought the Democratic nomination for a U.S. Senate seat in Maryland. Recently, she founded Lucky Planet Foods, a company that provides plant-based, low carbon foods.
Bone fractures more likely to occur in psoriasis, PsA patients
Individuals who have psoriasis or psoriatic arthritis are at a significantly higher risk of also suffering bone fractures, particularly in their hip and vertebrae, according to a new study published in the Annals of the Rheumatic Diseases.
“To our knowledge, these are the first population-based estimates of the risk for incident fracture and osteoporosis in patients with psoriasis and/or PsA [psoriatic arthritis] and the first longitudinal cohort study to address this issue,” wrote the authors of the study, led by Alexis Ogdie-Beatty, MD, of the University of Pennsylvania in Philadelphia (Ann Rheum Dis. 2017 Jan 16. doi: 10.1136/annrheumdis-2016-210441).
A total of 9,788 PsA and 158,323 psoriasis patients were included in the study, along with 39,306 RA patients and 821,834 individuals from the general population. Psoriasis patients were divided into groups classified as mild (n = 149,809) or severe (n = 8,514). The average age of each cohort ranged from nearly 47 years to almost 59 years, with all cohorts comprising mostly females, ranging from about 51% to 69%.
“We found that the risk for any fracture in patients with PsA and severe psoriasis was similar to RA [but] patients with PsA and psoriasis had an increased incidence of fracture compared with the general population by 7%-26%,” the authors explained. “The incidence of vertebral fracture was also increased in patients with severe psoriasis and while hip fracture was elevated in both psoriasis groups, it was only statistically significant in patients with mild psoriasis relative to matched controls after adjusting for risk factors for osteoporosis.”
Dr. Ogdie-Beatty and her colleagues found that all of the conditions conferred an elevated risk for fractures anywhere in the body when compared with the general population, reaching hazard ratios of 1.16 (95% confidence interval, 1.06-1.27) for people with PsA, 1.07 (95% CI, 1.05-1.10) for mild psoriasis, 1.26 for severe psoriasis (95% CI, 1.15-1.39), and 1.23 for RA (95% CI, 1.18-1.28). The risk for hip fractures was only significantly higher for mild (hazard ratio, 1.13; 95% CI, 1.04-1.22) and severe psoriasis (HR, 1.21; 95% CI, 0.88-1.66), and RA (HR, 1.55; 95% CI, 1.40-1.72). Individuals with PsA did not have a significantly higher risk for vertebral fractures (HR, 1.07; 95% CI, 0.66-1.72), whereas those with mild psoriasis (HR, 1.17; 95% CI, 1.03-1.33), severe psoriasis (HR, 2.23; 95% CI, 1.54-3.22), or RA did (HR, 1.53; 95% CI, 1.30-1.80). Each of these models were fully adjusted for multiple different osteoporosis risk factors, although they were all commonly adjusted for age, sex, atrial fibrillation, diabetes, chronic obstructive pulmonary disease, stroke, SSRI use, tricyclic antidepressant use, oral steroids, smoking, and categorical body mass index.
Individual coauthors disclosed receiving funding for their work from the National Institutes of Health, as well as grants from the Department of Veterans Affairs and the Rheumatology Research Foundation. Three of the authors reported receiving payment for continuing medical education work related to psoriatic arthritis or psoriasis.
Individuals who have psoriasis or psoriatic arthritis are at a significantly higher risk of also suffering bone fractures, particularly in their hip and vertebrae, according to a new study published in the Annals of the Rheumatic Diseases.
“To our knowledge, these are the first population-based estimates of the risk for incident fracture and osteoporosis in patients with psoriasis and/or PsA [psoriatic arthritis] and the first longitudinal cohort study to address this issue,” wrote the authors of the study, led by Alexis Ogdie-Beatty, MD, of the University of Pennsylvania in Philadelphia (Ann Rheum Dis. 2017 Jan 16. doi: 10.1136/annrheumdis-2016-210441).
A total of 9,788 PsA and 158,323 psoriasis patients were included in the study, along with 39,306 RA patients and 821,834 individuals from the general population. Psoriasis patients were divided into groups classified as mild (n = 149,809) or severe (n = 8,514). The average age of each cohort ranged from nearly 47 years to almost 59 years, with all cohorts comprising mostly females, ranging from about 51% to 69%.
“We found that the risk for any fracture in patients with PsA and severe psoriasis was similar to RA [but] patients with PsA and psoriasis had an increased incidence of fracture compared with the general population by 7%-26%,” the authors explained. “The incidence of vertebral fracture was also increased in patients with severe psoriasis and while hip fracture was elevated in both psoriasis groups, it was only statistically significant in patients with mild psoriasis relative to matched controls after adjusting for risk factors for osteoporosis.”
Dr. Ogdie-Beatty and her colleagues found that all of the conditions conferred an elevated risk for fractures anywhere in the body when compared with the general population, reaching hazard ratios of 1.16 (95% confidence interval, 1.06-1.27) for people with PsA, 1.07 (95% CI, 1.05-1.10) for mild psoriasis, 1.26 for severe psoriasis (95% CI, 1.15-1.39), and 1.23 for RA (95% CI, 1.18-1.28). The risk for hip fractures was only significantly higher for mild (hazard ratio, 1.13; 95% CI, 1.04-1.22) and severe psoriasis (HR, 1.21; 95% CI, 0.88-1.66), and RA (HR, 1.55; 95% CI, 1.40-1.72). Individuals with PsA did not have a significantly higher risk for vertebral fractures (HR, 1.07; 95% CI, 0.66-1.72), whereas those with mild psoriasis (HR, 1.17; 95% CI, 1.03-1.33), severe psoriasis (HR, 2.23; 95% CI, 1.54-3.22), or RA did (HR, 1.53; 95% CI, 1.30-1.80). Each of these models were fully adjusted for multiple different osteoporosis risk factors, although they were all commonly adjusted for age, sex, atrial fibrillation, diabetes, chronic obstructive pulmonary disease, stroke, SSRI use, tricyclic antidepressant use, oral steroids, smoking, and categorical body mass index.
Individual coauthors disclosed receiving funding for their work from the National Institutes of Health, as well as grants from the Department of Veterans Affairs and the Rheumatology Research Foundation. Three of the authors reported receiving payment for continuing medical education work related to psoriatic arthritis or psoriasis.
Individuals who have psoriasis or psoriatic arthritis are at a significantly higher risk of also suffering bone fractures, particularly in their hip and vertebrae, according to a new study published in the Annals of the Rheumatic Diseases.
“To our knowledge, these are the first population-based estimates of the risk for incident fracture and osteoporosis in patients with psoriasis and/or PsA [psoriatic arthritis] and the first longitudinal cohort study to address this issue,” wrote the authors of the study, led by Alexis Ogdie-Beatty, MD, of the University of Pennsylvania in Philadelphia (Ann Rheum Dis. 2017 Jan 16. doi: 10.1136/annrheumdis-2016-210441).
A total of 9,788 PsA and 158,323 psoriasis patients were included in the study, along with 39,306 RA patients and 821,834 individuals from the general population. Psoriasis patients were divided into groups classified as mild (n = 149,809) or severe (n = 8,514). The average age of each cohort ranged from nearly 47 years to almost 59 years, with all cohorts comprising mostly females, ranging from about 51% to 69%.
“We found that the risk for any fracture in patients with PsA and severe psoriasis was similar to RA [but] patients with PsA and psoriasis had an increased incidence of fracture compared with the general population by 7%-26%,” the authors explained. “The incidence of vertebral fracture was also increased in patients with severe psoriasis and while hip fracture was elevated in both psoriasis groups, it was only statistically significant in patients with mild psoriasis relative to matched controls after adjusting for risk factors for osteoporosis.”
Dr. Ogdie-Beatty and her colleagues found that all of the conditions conferred an elevated risk for fractures anywhere in the body when compared with the general population, reaching hazard ratios of 1.16 (95% confidence interval, 1.06-1.27) for people with PsA, 1.07 (95% CI, 1.05-1.10) for mild psoriasis, 1.26 for severe psoriasis (95% CI, 1.15-1.39), and 1.23 for RA (95% CI, 1.18-1.28). The risk for hip fractures was only significantly higher for mild (hazard ratio, 1.13; 95% CI, 1.04-1.22) and severe psoriasis (HR, 1.21; 95% CI, 0.88-1.66), and RA (HR, 1.55; 95% CI, 1.40-1.72). Individuals with PsA did not have a significantly higher risk for vertebral fractures (HR, 1.07; 95% CI, 0.66-1.72), whereas those with mild psoriasis (HR, 1.17; 95% CI, 1.03-1.33), severe psoriasis (HR, 2.23; 95% CI, 1.54-3.22), or RA did (HR, 1.53; 95% CI, 1.30-1.80). Each of these models were fully adjusted for multiple different osteoporosis risk factors, although they were all commonly adjusted for age, sex, atrial fibrillation, diabetes, chronic obstructive pulmonary disease, stroke, SSRI use, tricyclic antidepressant use, oral steroids, smoking, and categorical body mass index.
Individual coauthors disclosed receiving funding for their work from the National Institutes of Health, as well as grants from the Department of Veterans Affairs and the Rheumatology Research Foundation. Three of the authors reported receiving payment for continuing medical education work related to psoriatic arthritis or psoriasis.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point:
Major finding: The risk of fracture for patients with PsA and psoriasis had a risk of fracture that was increased by 7%-26% in comparison with the general U.K. population.
Data source: Population-based, longitudinal cohort study of 9,788 PsA patients and 158,323 psoriasis patients in the United Kingdom during 1994-2014.
Disclosures: Individual coauthors disclosed receiving funding for their work from the National Institutes of Health, as well as grants from the Department of Veterans Affairs and the Rheumatology Research Foundation. Three of the authors reported receiving payment for continuing medical education work related to psoriatic arthritis or psoriasis.
Nivolumab effective in PD-L1–deficient lung cancers
VIENNA – The oncologic immunotherapy drug nivolumab works by binding PD-1 receptors, but PD-L1 ligand levels in lung cancers do not predict how responsive patients are to the drug.
“While enhanced clinical activity with nivolumab correlates with increasing tumor PD-L1 expression, nivolumab-treated patients with little or no PD-L1 expression have a comparable probability of response, more durable responses, comparable overall survival, and fewer treatment-related adverse events, compared with patients treated with docetaxel,” Solange Peters, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
But a more detailed assessment of the survival data by Dr. Peters showed an unexpected pattern of an early hazard among the nivolumab patients. During the first 3 months on randomized treatment, 15 more patients died in the nivolumab arm than in the docetaxel arm. This quickly reversed during months 4-6 on treatment, when nine more patients died on docetaxel than on nivolumab, Dr. Peters reported. By 12 months after the onset of treatment, overall survival was 51% in the nivolumab group and 39% among those randomized to docetaxel.
A post hoc analysis showed a trend to a higher risk for death during the first 3 months of nivolumab treatment among patients with poorer prognostic features, more aggressive disease, and low or no tumor expression of PD-L1, Dr. Peters said.
Although patients with tumors with high levels of PD-L1 expression had the best response rate to nivolumab, patients with no PD-L1 expression had a response to nivolumab that was roughly equivalent to the response to docetaxel among patients randomized to chemotherapy. “Deep and durable responses were seen to nivolumab irrespective of the level of PD-L1 expression,” she said. Among patients with tumors that had a less than 1% rate of PD-L1 expression, the objective response rate was 9% with nivolumab and 15% with docetaxel. Among patients with tumors that had a PD-L1 expression rate of 1% or greater, the objective responses rate was 31% with nivolumab and 12% with docetaxel.
In a landmark analysis that excluded patients who died during the first 3 months on treatment, the pattern of responses to nivolumab and its advantage over docetaxel were similar among patients with no or low PD-L1 expression and among all patients enrolled in the study. In this landmark analysis, the hazard ratio for death after 3 months was reduced with nivolumab treatment by 34% among patients with no or low PD-L1 expression and by 31% in the entire study population, Dr. Peters reported.
CheckMate057 was funded by Bristol-Myers Squibb, the company that markets nivolumab (Opdivo). Dr. Peters has been a consultant to Bristol-Myers Squibb and to several other drug companies.
[email protected]
On Twitter @mitchelzoler
The new analyses reported by Dr. Peters addressed the question of whether patients who receive nivolumab in place of docetaxel are disadvantaged during the first 3 months of treatment. The data showed that in CheckMate057 an excess of 15 patients died in the group randomized to receive nivolumab during the first 3 months on treatment, compared with the control patients treated with docetaxel. This is concerning. Ideally, we’d like to see the patients treated with immunotherapy respond right away, but it takes time for immunotherapy to have an effect.
In almost all immunotherapy studies, a high proportion of patients, often about a third, progress during the first 2-3 months on treatment. It will be important to identify these patients and try new treatment approaches such as combined immunotherapies or a combination of chemotherapy with immunotherapy.
The early excess mortality of 15 patients with nivolumab seen in CheckMate057 must be viewed in context. It represents just 5% of patients randomized to receive nivolumab, and hence this finding should not influence clinical practice. Nivolumab treatment produced a very strong treatment benefit overall during follow-up at 12 and 18 months, compared with docetaxel in this study.
Immunotherapy agents like nivolumab have another advantage, compared with standard chemotherapy drugs, beyond better efficacy in selected patients. Immunotherapy drugs are also generally safer than chemotherapy agents, producing fewer adverse effects. For that reason alone, immunotherapy is preferred as long as its efficacy is comparable to that of chemotherapy. Even in patients with a tumor that does not express PD-L1, and even though some non–small cell lung cancer patients will die early when put on immunotherapy, overall opinion in the clinical community favors a drug like nivolumab over chemotherapy because of its better safety.
Paul Mitchell, MD, is a medical oncologist at the Olivia Newton-John Cancer and Wellness Centre in Heidelberg, Australia. He has served on advisory boards for AstraZeneca, Roche, Boehringer-Ingelheim, BMS, Merck/MSD, Merck Serono, and Celgene; he has received honoraria from Roche and Merck; and he has received travel grants from Roche and BMS. He made these comments as the designated discussant for the report and in an interview.
The new analyses reported by Dr. Peters addressed the question of whether patients who receive nivolumab in place of docetaxel are disadvantaged during the first 3 months of treatment. The data showed that in CheckMate057 an excess of 15 patients died in the group randomized to receive nivolumab during the first 3 months on treatment, compared with the control patients treated with docetaxel. This is concerning. Ideally, we’d like to see the patients treated with immunotherapy respond right away, but it takes time for immunotherapy to have an effect.
In almost all immunotherapy studies, a high proportion of patients, often about a third, progress during the first 2-3 months on treatment. It will be important to identify these patients and try new treatment approaches such as combined immunotherapies or a combination of chemotherapy with immunotherapy.
The early excess mortality of 15 patients with nivolumab seen in CheckMate057 must be viewed in context. It represents just 5% of patients randomized to receive nivolumab, and hence this finding should not influence clinical practice. Nivolumab treatment produced a very strong treatment benefit overall during follow-up at 12 and 18 months, compared with docetaxel in this study.
Immunotherapy agents like nivolumab have another advantage, compared with standard chemotherapy drugs, beyond better efficacy in selected patients. Immunotherapy drugs are also generally safer than chemotherapy agents, producing fewer adverse effects. For that reason alone, immunotherapy is preferred as long as its efficacy is comparable to that of chemotherapy. Even in patients with a tumor that does not express PD-L1, and even though some non–small cell lung cancer patients will die early when put on immunotherapy, overall opinion in the clinical community favors a drug like nivolumab over chemotherapy because of its better safety.
Paul Mitchell, MD, is a medical oncologist at the Olivia Newton-John Cancer and Wellness Centre in Heidelberg, Australia. He has served on advisory boards for AstraZeneca, Roche, Boehringer-Ingelheim, BMS, Merck/MSD, Merck Serono, and Celgene; he has received honoraria from Roche and Merck; and he has received travel grants from Roche and BMS. He made these comments as the designated discussant for the report and in an interview.
The new analyses reported by Dr. Peters addressed the question of whether patients who receive nivolumab in place of docetaxel are disadvantaged during the first 3 months of treatment. The data showed that in CheckMate057 an excess of 15 patients died in the group randomized to receive nivolumab during the first 3 months on treatment, compared with the control patients treated with docetaxel. This is concerning. Ideally, we’d like to see the patients treated with immunotherapy respond right away, but it takes time for immunotherapy to have an effect.
In almost all immunotherapy studies, a high proportion of patients, often about a third, progress during the first 2-3 months on treatment. It will be important to identify these patients and try new treatment approaches such as combined immunotherapies or a combination of chemotherapy with immunotherapy.
The early excess mortality of 15 patients with nivolumab seen in CheckMate057 must be viewed in context. It represents just 5% of patients randomized to receive nivolumab, and hence this finding should not influence clinical practice. Nivolumab treatment produced a very strong treatment benefit overall during follow-up at 12 and 18 months, compared with docetaxel in this study.
Immunotherapy agents like nivolumab have another advantage, compared with standard chemotherapy drugs, beyond better efficacy in selected patients. Immunotherapy drugs are also generally safer than chemotherapy agents, producing fewer adverse effects. For that reason alone, immunotherapy is preferred as long as its efficacy is comparable to that of chemotherapy. Even in patients with a tumor that does not express PD-L1, and even though some non–small cell lung cancer patients will die early when put on immunotherapy, overall opinion in the clinical community favors a drug like nivolumab over chemotherapy because of its better safety.
Paul Mitchell, MD, is a medical oncologist at the Olivia Newton-John Cancer and Wellness Centre in Heidelberg, Australia. He has served on advisory boards for AstraZeneca, Roche, Boehringer-Ingelheim, BMS, Merck/MSD, Merck Serono, and Celgene; he has received honoraria from Roche and Merck; and he has received travel grants from Roche and BMS. He made these comments as the designated discussant for the report and in an interview.
VIENNA – The oncologic immunotherapy drug nivolumab works by binding PD-1 receptors, but PD-L1 ligand levels in lung cancers do not predict how responsive patients are to the drug.
“While enhanced clinical activity with nivolumab correlates with increasing tumor PD-L1 expression, nivolumab-treated patients with little or no PD-L1 expression have a comparable probability of response, more durable responses, comparable overall survival, and fewer treatment-related adverse events, compared with patients treated with docetaxel,” Solange Peters, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
But a more detailed assessment of the survival data by Dr. Peters showed an unexpected pattern of an early hazard among the nivolumab patients. During the first 3 months on randomized treatment, 15 more patients died in the nivolumab arm than in the docetaxel arm. This quickly reversed during months 4-6 on treatment, when nine more patients died on docetaxel than on nivolumab, Dr. Peters reported. By 12 months after the onset of treatment, overall survival was 51% in the nivolumab group and 39% among those randomized to docetaxel.
A post hoc analysis showed a trend to a higher risk for death during the first 3 months of nivolumab treatment among patients with poorer prognostic features, more aggressive disease, and low or no tumor expression of PD-L1, Dr. Peters said.
Although patients with tumors with high levels of PD-L1 expression had the best response rate to nivolumab, patients with no PD-L1 expression had a response to nivolumab that was roughly equivalent to the response to docetaxel among patients randomized to chemotherapy. “Deep and durable responses were seen to nivolumab irrespective of the level of PD-L1 expression,” she said. Among patients with tumors that had a less than 1% rate of PD-L1 expression, the objective response rate was 9% with nivolumab and 15% with docetaxel. Among patients with tumors that had a PD-L1 expression rate of 1% or greater, the objective responses rate was 31% with nivolumab and 12% with docetaxel.
In a landmark analysis that excluded patients who died during the first 3 months on treatment, the pattern of responses to nivolumab and its advantage over docetaxel were similar among patients with no or low PD-L1 expression and among all patients enrolled in the study. In this landmark analysis, the hazard ratio for death after 3 months was reduced with nivolumab treatment by 34% among patients with no or low PD-L1 expression and by 31% in the entire study population, Dr. Peters reported.
CheckMate057 was funded by Bristol-Myers Squibb, the company that markets nivolumab (Opdivo). Dr. Peters has been a consultant to Bristol-Myers Squibb and to several other drug companies.
[email protected]
On Twitter @mitchelzoler
VIENNA – The oncologic immunotherapy drug nivolumab works by binding PD-1 receptors, but PD-L1 ligand levels in lung cancers do not predict how responsive patients are to the drug.
“While enhanced clinical activity with nivolumab correlates with increasing tumor PD-L1 expression, nivolumab-treated patients with little or no PD-L1 expression have a comparable probability of response, more durable responses, comparable overall survival, and fewer treatment-related adverse events, compared with patients treated with docetaxel,” Solange Peters, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
But a more detailed assessment of the survival data by Dr. Peters showed an unexpected pattern of an early hazard among the nivolumab patients. During the first 3 months on randomized treatment, 15 more patients died in the nivolumab arm than in the docetaxel arm. This quickly reversed during months 4-6 on treatment, when nine more patients died on docetaxel than on nivolumab, Dr. Peters reported. By 12 months after the onset of treatment, overall survival was 51% in the nivolumab group and 39% among those randomized to docetaxel.
A post hoc analysis showed a trend to a higher risk for death during the first 3 months of nivolumab treatment among patients with poorer prognostic features, more aggressive disease, and low or no tumor expression of PD-L1, Dr. Peters said.
Although patients with tumors with high levels of PD-L1 expression had the best response rate to nivolumab, patients with no PD-L1 expression had a response to nivolumab that was roughly equivalent to the response to docetaxel among patients randomized to chemotherapy. “Deep and durable responses were seen to nivolumab irrespective of the level of PD-L1 expression,” she said. Among patients with tumors that had a less than 1% rate of PD-L1 expression, the objective response rate was 9% with nivolumab and 15% with docetaxel. Among patients with tumors that had a PD-L1 expression rate of 1% or greater, the objective responses rate was 31% with nivolumab and 12% with docetaxel.
In a landmark analysis that excluded patients who died during the first 3 months on treatment, the pattern of responses to nivolumab and its advantage over docetaxel were similar among patients with no or low PD-L1 expression and among all patients enrolled in the study. In this landmark analysis, the hazard ratio for death after 3 months was reduced with nivolumab treatment by 34% among patients with no or low PD-L1 expression and by 31% in the entire study population, Dr. Peters reported.
CheckMate057 was funded by Bristol-Myers Squibb, the company that markets nivolumab (Opdivo). Dr. Peters has been a consultant to Bristol-Myers Squibb and to several other drug companies.
[email protected]
On Twitter @mitchelzoler
AT WCLC 2016
Key clinical point:
Major finding: When tumors had at least 1% PD-L1 expression, objective response rates were 31% with nivolumab and 12% with docetaxel.
Data source: CheckMate057, a pivotal trial of nivolumab that enrolled 592 patients with advanced, nonsquamous non–small cell lung cancer.
Disclosures: CheckMate057 was funded by Bristol-Myers Squibb, the company that markets nivolumab (Opdivo). Dr. Peters has been a consultant to Bristol-Myers Squibb and to several other drug companies.
Vagus Nerve Stimulation Reduces Seizures and Improves Quality of Life
Patients with epilepsy who do not respond to drug therapy and who are not candidates for surgery sometimes respond to vagus nerve stimulation (VNS). Research suggests that VNS reduces the frequency of seizures, but a recent study now suggests it may also improve patients’ quality of life. Englot et al found that the therapy improves alertness, post-ictal state, cluster seizures, mood, verbal communication, school and professional achievements, and memory. Several factors predicted patients’ improvement, including a shorter time to implant, female gender, generalized seizure type, and being Caucasian.
Englot DJ, Hassnain KH, Rolston JD, et al. Quality-of-life metrics with vagus nerve stimulation for epilepsy from provider survey data. Epilepsy Behav. 2017;66:4-9.
Patients with epilepsy who do not respond to drug therapy and who are not candidates for surgery sometimes respond to vagus nerve stimulation (VNS). Research suggests that VNS reduces the frequency of seizures, but a recent study now suggests it may also improve patients’ quality of life. Englot et al found that the therapy improves alertness, post-ictal state, cluster seizures, mood, verbal communication, school and professional achievements, and memory. Several factors predicted patients’ improvement, including a shorter time to implant, female gender, generalized seizure type, and being Caucasian.
Englot DJ, Hassnain KH, Rolston JD, et al. Quality-of-life metrics with vagus nerve stimulation for epilepsy from provider survey data. Epilepsy Behav. 2017;66:4-9.
Patients with epilepsy who do not respond to drug therapy and who are not candidates for surgery sometimes respond to vagus nerve stimulation (VNS). Research suggests that VNS reduces the frequency of seizures, but a recent study now suggests it may also improve patients’ quality of life. Englot et al found that the therapy improves alertness, post-ictal state, cluster seizures, mood, verbal communication, school and professional achievements, and memory. Several factors predicted patients’ improvement, including a shorter time to implant, female gender, generalized seizure type, and being Caucasian.
Englot DJ, Hassnain KH, Rolston JD, et al. Quality-of-life metrics with vagus nerve stimulation for epilepsy from provider survey data. Epilepsy Behav. 2017;66:4-9.