SAN DIEGO – No adverse interaction occurred between the dipeptidyl peptidase–4 inhibitor alogliptin and ACE inhibitors in patients with high cardiovascular risk and type 2 diabetes enrolled in the EXAMINE trial.

This is reassuring news that puts to rest concerns that patients on these two classes of medications might experience an increase in cardiovascular events, Dr. Christopher P. Cannon said at the annual meeting of the American College of Cardiology.

These concerns arose from evidence suggesting the possibility that DPP-4 inhibition in the presence of higher-dose ACE inhibitor therapy might activate the sympathetic nervous system through an increase in substance P, with a resultant elevated risk of serious cardiovascular events.

This hypothesis was tested in a secondary analysis of the EXAMINE (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care) trial. In EXAMINE, 5,380 patients with type 2 diabetes and a history of an acute coronary syndrome within the previous 90 days were randomized in a double-blind fashion to oral alogliptin (Nesina) or placebo on top of standard guideline-directed medical therapy for type 2 diabetes and cardiovascular risk factors. They were prospectively followed for a median of 18 months and a maximum of 40 months.

The primary results of EXAMINE have been reported previously: Among patients with type 2 diabetes and a recent acute coronary syndrome, major adverse cardiovascular events weren’t increased with agoliptin, compared with placebo (N. Engl. J. Med. 2013;369:1327-35). But because of subsequent theoretical safety questions raised about dual therapy with agoliptin and an ACE inhibitor – and in light of the fact that 3,323 participants in EXAMINE were on background ACE inhibitor therapy – the investigators decided to perform this new secondary analysis, according to Dr. Cannon, professor of medicine at Harvard Medical School, Boston.

The composite primary endpoint comprised of cardiovascular death, nonfatal MI, and nonfatal stroke occurred in 11.4% of subjects on alogliptin plus an ACE inhibitor, compared with 11.8% of those on placebo plus an ACE inhibitor, 11.2% of patients on alogliptin without an ACE inhibitor, and 11.9% of those not on alogliptin or an ACE inhibitor.

The secondary composite endpoint of cardiovascular death or hospitalization for heart failure occurred in 6.8% of patients on alogliptin and an ACE inhibitor, 7.2% of those on placebo plus an ACE inhibitor, 8.5% of subjects on alogliptin but no ACE inhibitor, and 8.0% of those on neither – again, with no significant differences.

The EXAMINE trial was funded by Takeda Pharmaceuticals. Dr. Cannon reported serving as a consultant to that company and numerous other pharmaceutical companies.

[email protected]

SAN DIEGO – No adverse interaction occurred between the dipeptidyl peptidase–4 inhibitor alogliptin and ACE inhibitors in patients with high cardiovascular risk and type 2 diabetes enrolled in the EXAMINE trial.

This is reassuring news that puts to rest concerns that patients on these two classes of medications might experience an increase in cardiovascular events, Dr. Christopher P. Cannon said at the annual meeting of the American College of Cardiology.

These concerns arose from evidence suggesting the possibility that DPP-4 inhibition in the presence of higher-dose ACE inhibitor therapy might activate the sympathetic nervous system through an increase in substance P, with a resultant elevated risk of serious cardiovascular events.

This hypothesis was tested in a secondary analysis of the EXAMINE (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care) trial. In EXAMINE, 5,380 patients with type 2 diabetes and a history of an acute coronary syndrome within the previous 90 days were randomized in a double-blind fashion to oral alogliptin (Nesina) or placebo on top of standard guideline-directed medical therapy for type 2 diabetes and cardiovascular risk factors. They were prospectively followed for a median of 18 months and a maximum of 40 months.

The primary results of EXAMINE have been reported previously: Among patients with type 2 diabetes and a recent acute coronary syndrome, major adverse cardiovascular events weren’t increased with agoliptin, compared with placebo (N. Engl. J. Med. 2013;369:1327-35). But because of subsequent theoretical safety questions raised about dual therapy with agoliptin and an ACE inhibitor – and in light of the fact that 3,323 participants in EXAMINE were on background ACE inhibitor therapy – the investigators decided to perform this new secondary analysis, according to Dr. Cannon, professor of medicine at Harvard Medical School, Boston.

The composite primary endpoint comprised of cardiovascular death, nonfatal MI, and nonfatal stroke occurred in 11.4% of subjects on alogliptin plus an ACE inhibitor, compared with 11.8% of those on placebo plus an ACE inhibitor, 11.2% of patients on alogliptin without an ACE inhibitor, and 11.9% of those not on alogliptin or an ACE inhibitor.

The secondary composite endpoint of cardiovascular death or hospitalization for heart failure occurred in 6.8% of patients on alogliptin and an ACE inhibitor, 7.2% of those on placebo plus an ACE inhibitor, 8.5% of subjects on alogliptin but no ACE inhibitor, and 8.0% of those on neither – again, with no significant differences.

The EXAMINE trial was funded by Takeda Pharmaceuticals. Dr. Cannon reported serving as a consultant to that company and numerous other pharmaceutical companies.

[email protected]

SAN DIEGO – No adverse interaction occurred between the dipeptidyl peptidase–4 inhibitor alogliptin and ACE inhibitors in patients with high cardiovascular risk and type 2 diabetes enrolled in the EXAMINE trial.

This is reassuring news that puts to rest concerns that patients on these two classes of medications might experience an increase in cardiovascular events, Dr. Christopher P. Cannon said at the annual meeting of the American College of Cardiology.

These concerns arose from evidence suggesting the possibility that DPP-4 inhibition in the presence of higher-dose ACE inhibitor therapy might activate the sympathetic nervous system through an increase in substance P, with a resultant elevated risk of serious cardiovascular events.

This hypothesis was tested in a secondary analysis of the EXAMINE (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care) trial. In EXAMINE, 5,380 patients with type 2 diabetes and a history of an acute coronary syndrome within the previous 90 days were randomized in a double-blind fashion to oral alogliptin (Nesina) or placebo on top of standard guideline-directed medical therapy for type 2 diabetes and cardiovascular risk factors. They were prospectively followed for a median of 18 months and a maximum of 40 months.

The primary results of EXAMINE have been reported previously: Among patients with type 2 diabetes and a recent acute coronary syndrome, major adverse cardiovascular events weren’t increased with agoliptin, compared with placebo (N. Engl. J. Med. 2013;369:1327-35). But because of subsequent theoretical safety questions raised about dual therapy with agoliptin and an ACE inhibitor – and in light of the fact that 3,323 participants in EXAMINE were on background ACE inhibitor therapy – the investigators decided to perform this new secondary analysis, according to Dr. Cannon, professor of medicine at Harvard Medical School, Boston.

The composite primary endpoint comprised of cardiovascular death, nonfatal MI, and nonfatal stroke occurred in 11.4% of subjects on alogliptin plus an ACE inhibitor, compared with 11.8% of those on placebo plus an ACE inhibitor, 11.2% of patients on alogliptin without an ACE inhibitor, and 11.9% of those not on alogliptin or an ACE inhibitor.

The secondary composite endpoint of cardiovascular death or hospitalization for heart failure occurred in 6.8% of patients on alogliptin and an ACE inhibitor, 7.2% of those on placebo plus an ACE inhibitor, 8.5% of subjects on alogliptin but no ACE inhibitor, and 8.0% of those on neither – again, with no significant differences.

The EXAMINE trial was funded by Takeda Pharmaceuticals. Dr. Cannon reported serving as a consultant to that company and numerous other pharmaceutical companies.

[email protected]

SAN FRANCISCO – Among Asian and Hispanic patients, women are more likely than men are to get nonmelanoma skin cancer, according to a review of 4,029 cases at the University of California, San Diego.

That’s a surprise, because the reverse is true in whites, and skin cancer is generally thought to be more common in men.

About 96% of the cases were in white patients, and two-thirds of those were in men. Among Hispanic and Asian patients, about two-thirds of the cases were in women.

The reason for the gender reversal is unclear, but the study has a clear message, according to study investigator Dr. Arisa Ortiz, director of laser and cosmetic dermatology at the university. She shared that message in an interview at the American Academy of Dermatology annual meeting.

[email protected]

SAN FRANCISCO – Among Asian and Hispanic patients, women are more likely than men are to get nonmelanoma skin cancer, according to a review of 4,029 cases at the University of California, San Diego.

That’s a surprise, because the reverse is true in whites, and skin cancer is generally thought to be more common in men.

About 96% of the cases were in white patients, and two-thirds of those were in men. Among Hispanic and Asian patients, about two-thirds of the cases were in women.

The reason for the gender reversal is unclear, but the study has a clear message, according to study investigator Dr. Arisa Ortiz, director of laser and cosmetic dermatology at the university. She shared that message in an interview at the American Academy of Dermatology annual meeting.

[email protected]

SAN FRANCISCO – Among Asian and Hispanic patients, women are more likely than men are to get nonmelanoma skin cancer, according to a review of 4,029 cases at the University of California, San Diego.

That’s a surprise, because the reverse is true in whites, and skin cancer is generally thought to be more common in men.

About 96% of the cases were in white patients, and two-thirds of those were in men. Among Hispanic and Asian patients, about two-thirds of the cases were in women.

The reason for the gender reversal is unclear, but the study has a clear message, according to study investigator Dr. Arisa Ortiz, director of laser and cosmetic dermatology at the university. She shared that message in an interview at the American Academy of Dermatology annual meeting.

[email protected]

The Food and Drug Administration has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), for treatment of inhalational anthrax when used with appropriate antibacterial drugs.

Inhalational anthrax is caused by breathing in Bacillus anthracis spores, which can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of spores. In a statement, Dr. Karen Midthun – director of the FDA’s Center for Biologics Evaluation and Research – explained that Anthrasil “will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.”

Anthrasil was purchased by the U.S. Department of Health & Human Services’ Biomedical Advanced Research and Development Authority (BARDA) in 2011, but because it was not approved, its use prior to FDA approval would have required an emergency use authorization from the FDA.

The efficacy of Anthrasil was studied in animals because it was not feasible or ethical to conduct adequately controlled efficacy studies in humans, the FDA said. Monkeys and rabbits were exposed to Bacillus anthracis spores, and subsequently given either Anthrasil or a placebo. The survival rate for monkeys given Anthrasil was between 36% and 70%, with a trend toward increased survival at higher doses of Anthrasil. None of the monkeys given placebo survived. Rabbits had a 26% survival rate when given the drug, compared to 2% of those given placebo. A separate study exposed rabbits to Bacillus anthracis and treated them with either antibiotics or a combination of antibiotics and Anthrasil; survival rates were 71% for those treated with the combination and 25% for those treated with antibiotics only.

Safety was tested in 74 healthy human volunteers and the most commonly reported side effects were headache, back pain, nausea, and pain and swelling at the infusion site.

Anthrasil is manufactured by Cangene Corporation, based in Winnipeg, Canada, which developed the drug in collaboration with BARDA.

[email protected]

The Food and Drug Administration has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), for treatment of inhalational anthrax when used with appropriate antibacterial drugs.

Inhalational anthrax is caused by breathing in Bacillus anthracis spores, which can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of spores. In a statement, Dr. Karen Midthun – director of the FDA’s Center for Biologics Evaluation and Research – explained that Anthrasil “will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.”

Anthrasil was purchased by the U.S. Department of Health & Human Services’ Biomedical Advanced Research and Development Authority (BARDA) in 2011, but because it was not approved, its use prior to FDA approval would have required an emergency use authorization from the FDA.

The efficacy of Anthrasil was studied in animals because it was not feasible or ethical to conduct adequately controlled efficacy studies in humans, the FDA said. Monkeys and rabbits were exposed to Bacillus anthracis spores, and subsequently given either Anthrasil or a placebo. The survival rate for monkeys given Anthrasil was between 36% and 70%, with a trend toward increased survival at higher doses of Anthrasil. None of the monkeys given placebo survived. Rabbits had a 26% survival rate when given the drug, compared to 2% of those given placebo. A separate study exposed rabbits to Bacillus anthracis and treated them with either antibiotics or a combination of antibiotics and Anthrasil; survival rates were 71% for those treated with the combination and 25% for those treated with antibiotics only.

Safety was tested in 74 healthy human volunteers and the most commonly reported side effects were headache, back pain, nausea, and pain and swelling at the infusion site.

Anthrasil is manufactured by Cangene Corporation, based in Winnipeg, Canada, which developed the drug in collaboration with BARDA.

[email protected]

The Food and Drug Administration has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), for treatment of inhalational anthrax when used with appropriate antibacterial drugs.

Inhalational anthrax is caused by breathing in Bacillus anthracis spores, which can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of spores. In a statement, Dr. Karen Midthun – director of the FDA’s Center for Biologics Evaluation and Research – explained that Anthrasil “will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.”

Anthrasil was purchased by the U.S. Department of Health & Human Services’ Biomedical Advanced Research and Development Authority (BARDA) in 2011, but because it was not approved, its use prior to FDA approval would have required an emergency use authorization from the FDA.

The efficacy of Anthrasil was studied in animals because it was not feasible or ethical to conduct adequately controlled efficacy studies in humans, the FDA said. Monkeys and rabbits were exposed to Bacillus anthracis spores, and subsequently given either Anthrasil or a placebo. The survival rate for monkeys given Anthrasil was between 36% and 70%, with a trend toward increased survival at higher doses of Anthrasil. None of the monkeys given placebo survived. Rabbits had a 26% survival rate when given the drug, compared to 2% of those given placebo. A separate study exposed rabbits to Bacillus anthracis and treated them with either antibiotics or a combination of antibiotics and Anthrasil; survival rates were 71% for those treated with the combination and 25% for those treated with antibiotics only.

Safety was tested in 74 healthy human volunteers and the most commonly reported side effects were headache, back pain, nausea, and pain and swelling at the infusion site.

Anthrasil is manufactured by Cangene Corporation, based in Winnipeg, Canada, which developed the drug in collaboration with BARDA.

[email protected]

SAN FRANCISCO — A growing number of antibiotic-resistant infections have been reported following use of duodenoscopes, which are used in the advanced procedure endoscopic retrograde cholangiopancreatography, or ERCP. The American Gastroenterological Association (AGA) Center for GI Innovation and Technology convened a meeting on March 23, 2015, “Getting to Zero,” with experts in gastroenterology, epidemiology and infectious disease; the endoscope manufacturers Fuji and Pentax; and representatives from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and ECRI Institute to discuss how to prevent these infections.

“More than 500,000 ERCPs are performed each year throughout the U.S., saving the lives of hundreds of thousands of patients with very serious illnesses,” said AGA President Dr. John I. Allen, MBA, AGAF. “The value of these procedures can not be understated. AGA is committed to finding a path forward to remove the risk of device-transmitted infections and ensure safe patient care.”

“We must stop device-associated infections. It’s a complex issue without an easy solution, but first we need to protect our patients,” added Dr. Michael Kochman, AGAF, chair of the AGA Center for GI Innovation and Technology, explaining this means educating patients, redesigning the endoscopes, and finding new ways to clean them.The problem of this infection transmission lies in the complex design of the elevator channel in duodenoscopes, which can allow bacteria to remain after cleansing, even if reprocessing follows currently accepted procedures developed and approved by the manufacturers and FDA. Meeting participants also acknowledged other potential sites of failure in the design.

AGA supports current FDA and CDC guidance and suggests the following additional recommendations to improve patient safety.

Short-term recommendations for physicians

1. Treat all elevator-channel endoscopes the same, including both FNA echoendoscopes (EUS) and duodenoscopes.

2. Continue to follow the recently enhanced manufacturer reprocessing guidelines. Currently, FDA is working with each endoscope manufacturer to validate their enhanced reprocessing protocols.

3. Elevator-channel endoscopes should be tracked by patient and by device serial number to facilitate retrospective identification in case of infection.

4. Establish a two-phase infection surveillance program: a) track all patients who have had a procedure with an elevator-channel endoscope and b) periodically collect culture surveillance of all elevator-channel endoscopes.

5. Baseline culturing of all elevator-channel endoscopes is prudent; the sensitivity is unknown at this time. Importantly, a positive culture should trigger a thorough review of your reprocessing technique.

6. Develop a standard device reprocessing training program and ensure reprocessing staff demonstrate competency every 6 months, as well as with the introduction of new model endoscopes.

7. If you suspect a breach or infection, contact CDC immediately to aid in investigation.

Long-term recommendation: Device redesign

Further study of the failure modes resulting in the transmission of infection will inform the necessary components of a device redesign. FDA has committed to expeditiously review validation data for alternative scope designs that mitigate the risk of transmitting infection.

What Patients Need to Know

Most people will never have an ERCP. But for patients who need it, ERCP is a critical and life-saving procedure. ERCP is the least invasive way for doctors to diagnose and treat problems in the bile duct and pancreatic ducts, including infections, stones, tumors and blockages. Experts all agree that there is no demonstrable infection transmission risk related to upper endoscopy or colonoscopy. Patients should not defer or avoid these procedures, which include colon cancer screening tests.

To put the issue in perspective, the infectious complication rate for theses specific types of infections is about 150 out of more than 1 million procedures over the last two years. The therapeutic benefits of this procedure far outweigh the potential low risk of infection.

For more information about these bacteria, visit the CDC website.

AGA appreciates the involvement of CDC, FDA, Fuji, Pentax, ECRI Institute, and the GI and infectious disease experts in developing these recommendations and for their commitment to “Getting to Zero.”

SAN FRANCISCO — A growing number of antibiotic-resistant infections have been reported following use of duodenoscopes, which are used in the advanced procedure endoscopic retrograde cholangiopancreatography, or ERCP. The American Gastroenterological Association (AGA) Center for GI Innovation and Technology convened a meeting on March 23, 2015, “Getting to Zero,” with experts in gastroenterology, epidemiology and infectious disease; the endoscope manufacturers Fuji and Pentax; and representatives from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and ECRI Institute to discuss how to prevent these infections.

“More than 500,000 ERCPs are performed each year throughout the U.S., saving the lives of hundreds of thousands of patients with very serious illnesses,” said AGA President Dr. John I. Allen, MBA, AGAF. “The value of these procedures can not be understated. AGA is committed to finding a path forward to remove the risk of device-transmitted infections and ensure safe patient care.”

“We must stop device-associated infections. It’s a complex issue without an easy solution, but first we need to protect our patients,” added Dr. Michael Kochman, AGAF, chair of the AGA Center for GI Innovation and Technology, explaining this means educating patients, redesigning the endoscopes, and finding new ways to clean them.The problem of this infection transmission lies in the complex design of the elevator channel in duodenoscopes, which can allow bacteria to remain after cleansing, even if reprocessing follows currently accepted procedures developed and approved by the manufacturers and FDA. Meeting participants also acknowledged other potential sites of failure in the design.

AGA supports current FDA and CDC guidance and suggests the following additional recommendations to improve patient safety.

Short-term recommendations for physicians

1. Treat all elevator-channel endoscopes the same, including both FNA echoendoscopes (EUS) and duodenoscopes.

2. Continue to follow the recently enhanced manufacturer reprocessing guidelines. Currently, FDA is working with each endoscope manufacturer to validate their enhanced reprocessing protocols.

3. Elevator-channel endoscopes should be tracked by patient and by device serial number to facilitate retrospective identification in case of infection.

4. Establish a two-phase infection surveillance program: a) track all patients who have had a procedure with an elevator-channel endoscope and b) periodically collect culture surveillance of all elevator-channel endoscopes.

5. Baseline culturing of all elevator-channel endoscopes is prudent; the sensitivity is unknown at this time. Importantly, a positive culture should trigger a thorough review of your reprocessing technique.

6. Develop a standard device reprocessing training program and ensure reprocessing staff demonstrate competency every 6 months, as well as with the introduction of new model endoscopes.

7. If you suspect a breach or infection, contact CDC immediately to aid in investigation.

Long-term recommendation: Device redesign

Further study of the failure modes resulting in the transmission of infection will inform the necessary components of a device redesign. FDA has committed to expeditiously review validation data for alternative scope designs that mitigate the risk of transmitting infection.

What Patients Need to Know

Most people will never have an ERCP. But for patients who need it, ERCP is a critical and life-saving procedure. ERCP is the least invasive way for doctors to diagnose and treat problems in the bile duct and pancreatic ducts, including infections, stones, tumors and blockages. Experts all agree that there is no demonstrable infection transmission risk related to upper endoscopy or colonoscopy. Patients should not defer or avoid these procedures, which include colon cancer screening tests.

To put the issue in perspective, the infectious complication rate for theses specific types of infections is about 150 out of more than 1 million procedures over the last two years. The therapeutic benefits of this procedure far outweigh the potential low risk of infection.

For more information about these bacteria, visit the CDC website.

AGA appreciates the involvement of CDC, FDA, Fuji, Pentax, ECRI Institute, and the GI and infectious disease experts in developing these recommendations and for their commitment to “Getting to Zero.”

SAN FRANCISCO — A growing number of antibiotic-resistant infections have been reported following use of duodenoscopes, which are used in the advanced procedure endoscopic retrograde cholangiopancreatography, or ERCP. The American Gastroenterological Association (AGA) Center for GI Innovation and Technology convened a meeting on March 23, 2015, “Getting to Zero,” with experts in gastroenterology, epidemiology and infectious disease; the endoscope manufacturers Fuji and Pentax; and representatives from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and ECRI Institute to discuss how to prevent these infections.

“More than 500,000 ERCPs are performed each year throughout the U.S., saving the lives of hundreds of thousands of patients with very serious illnesses,” said AGA President Dr. John I. Allen, MBA, AGAF. “The value of these procedures can not be understated. AGA is committed to finding a path forward to remove the risk of device-transmitted infections and ensure safe patient care.”

“We must stop device-associated infections. It’s a complex issue without an easy solution, but first we need to protect our patients,” added Dr. Michael Kochman, AGAF, chair of the AGA Center for GI Innovation and Technology, explaining this means educating patients, redesigning the endoscopes, and finding new ways to clean them.The problem of this infection transmission lies in the complex design of the elevator channel in duodenoscopes, which can allow bacteria to remain after cleansing, even if reprocessing follows currently accepted procedures developed and approved by the manufacturers and FDA. Meeting participants also acknowledged other potential sites of failure in the design.

AGA supports current FDA and CDC guidance and suggests the following additional recommendations to improve patient safety.

Short-term recommendations for physicians

1. Treat all elevator-channel endoscopes the same, including both FNA echoendoscopes (EUS) and duodenoscopes.

2. Continue to follow the recently enhanced manufacturer reprocessing guidelines. Currently, FDA is working with each endoscope manufacturer to validate their enhanced reprocessing protocols.

3. Elevator-channel endoscopes should be tracked by patient and by device serial number to facilitate retrospective identification in case of infection.

4. Establish a two-phase infection surveillance program: a) track all patients who have had a procedure with an elevator-channel endoscope and b) periodically collect culture surveillance of all elevator-channel endoscopes.

5. Baseline culturing of all elevator-channel endoscopes is prudent; the sensitivity is unknown at this time. Importantly, a positive culture should trigger a thorough review of your reprocessing technique.

6. Develop a standard device reprocessing training program and ensure reprocessing staff demonstrate competency every 6 months, as well as with the introduction of new model endoscopes.

7. If you suspect a breach or infection, contact CDC immediately to aid in investigation.

Long-term recommendation: Device redesign

Further study of the failure modes resulting in the transmission of infection will inform the necessary components of a device redesign. FDA has committed to expeditiously review validation data for alternative scope designs that mitigate the risk of transmitting infection.

What Patients Need to Know

Most people will never have an ERCP. But for patients who need it, ERCP is a critical and life-saving procedure. ERCP is the least invasive way for doctors to diagnose and treat problems in the bile duct and pancreatic ducts, including infections, stones, tumors and blockages. Experts all agree that there is no demonstrable infection transmission risk related to upper endoscopy or colonoscopy. Patients should not defer or avoid these procedures, which include colon cancer screening tests.

To put the issue in perspective, the infectious complication rate for theses specific types of infections is about 150 out of more than 1 million procedures over the last two years. The therapeutic benefits of this procedure far outweigh the potential low risk of infection.

For more information about these bacteria, visit the CDC website.

AGA appreciates the involvement of CDC, FDA, Fuji, Pentax, ECRI Institute, and the GI and infectious disease experts in developing these recommendations and for their commitment to “Getting to Zero.”

Among pulmonary embolism patients with malignancy, post-treatment lengths of survival were higher for those who received long-term low-molecular-weight heparin (LMWH) than for those who received oral vitamin K agonist (VKA), according to a prospective study.

Of the 92 PE patients with malignancy studied, 56 received long-term LMWH and 36 received oral VKA. The long-term LMWH treatment group had a median survival time of 30 months, which was significantly longer than the 12.5-month median survival time of the VKA treatment group, according to Shuai Zhang and colleagues.

The overall mortality rate for patients with malignancy was 48.9%, and the mortality rates of patients with malignancy treated with LMWH and VKA were 44.4% and 55.4%, respectively. Although a higher percentage of the LMWH treatment group survived than the VKA treatment group, the difference between the groups’ overall survival rates was not significant. However, the median survival time was significantly longer in the LMWH group than the VKA group (30 months vs. 12.5 months; P = .041), with the rate of all-cause death in the first 6 months decreased by long-term therapy with LMWH (19.6% vs. 41.7%; P = .022). In the multivariable Cox regression, long-term LMWH was a protective factor for all-cause death in the first 6 months (hazard ratio, 0.399; P = .022).

PE patients with malignancies could more effectively protect their lives and extend their survival time by using LMWH for at least 3 months instead of oral VKA, the investigators said. “In order to evaluate the impact of extended duration of LMWH on mortality, randomized controlled trials with [a] large sample size need to be designed,” they said.

Find the full study in Thrombosis Research (doi.org/10.1016/j.thromres.2014.11.015).

Among pulmonary embolism patients with malignancy, post-treatment lengths of survival were higher for those who received long-term low-molecular-weight heparin (LMWH) than for those who received oral vitamin K agonist (VKA), according to a prospective study.

Of the 92 PE patients with malignancy studied, 56 received long-term LMWH and 36 received oral VKA. The long-term LMWH treatment group had a median survival time of 30 months, which was significantly longer than the 12.5-month median survival time of the VKA treatment group, according to Shuai Zhang and colleagues.

The overall mortality rate for patients with malignancy was 48.9%, and the mortality rates of patients with malignancy treated with LMWH and VKA were 44.4% and 55.4%, respectively. Although a higher percentage of the LMWH treatment group survived than the VKA treatment group, the difference between the groups’ overall survival rates was not significant. However, the median survival time was significantly longer in the LMWH group than the VKA group (30 months vs. 12.5 months; P = .041), with the rate of all-cause death in the first 6 months decreased by long-term therapy with LMWH (19.6% vs. 41.7%; P = .022). In the multivariable Cox regression, long-term LMWH was a protective factor for all-cause death in the first 6 months (hazard ratio, 0.399; P = .022).

PE patients with malignancies could more effectively protect their lives and extend their survival time by using LMWH for at least 3 months instead of oral VKA, the investigators said. “In order to evaluate the impact of extended duration of LMWH on mortality, randomized controlled trials with [a] large sample size need to be designed,” they said.

Find the full study in Thrombosis Research (doi.org/10.1016/j.thromres.2014.11.015).

Among pulmonary embolism patients with malignancy, post-treatment lengths of survival were higher for those who received long-term low-molecular-weight heparin (LMWH) than for those who received oral vitamin K agonist (VKA), according to a prospective study.

Of the 92 PE patients with malignancy studied, 56 received long-term LMWH and 36 received oral VKA. The long-term LMWH treatment group had a median survival time of 30 months, which was significantly longer than the 12.5-month median survival time of the VKA treatment group, according to Shuai Zhang and colleagues.

The overall mortality rate for patients with malignancy was 48.9%, and the mortality rates of patients with malignancy treated with LMWH and VKA were 44.4% and 55.4%, respectively. Although a higher percentage of the LMWH treatment group survived than the VKA treatment group, the difference between the groups’ overall survival rates was not significant. However, the median survival time was significantly longer in the LMWH group than the VKA group (30 months vs. 12.5 months; P = .041), with the rate of all-cause death in the first 6 months decreased by long-term therapy with LMWH (19.6% vs. 41.7%; P = .022). In the multivariable Cox regression, long-term LMWH was a protective factor for all-cause death in the first 6 months (hazard ratio, 0.399; P = .022).

PE patients with malignancies could more effectively protect their lives and extend their survival time by using LMWH for at least 3 months instead of oral VKA, the investigators said. “In order to evaluate the impact of extended duration of LMWH on mortality, randomized controlled trials with [a] large sample size need to be designed,” they said.

Find the full study in Thrombosis Research (doi.org/10.1016/j.thromres.2014.11.015).

The American Academy of Orthopaedic Surgeons’ new guideline on the diagnosis and treatment of hip fractures in elderly patients targets problem areas such as postoperative delirium and pain management.

The clinical practice guideline, “Management of Hip Fractures in the Elderly,” addresses hip fractures in patients age 65 years and older and offers recommendations on issues such as the timing of surgery and the use of vitamin D.

© iStock / ThinkStockPhotos.com

The AAOS also hopes the guideline will expose gaps in the body of research literature that should be addressed in future studies. The guideline has been endorsed by the American Geriatrics Society, the U.S. Bone and Joint Initiative, the Orthopaedic Trauma Association, the American Association of Clinical Endocrinologists, and the Hip Society.

The guideline’s recommendations include:

• Regional analgesia should be used to improve preoperative pain control in patients with hip fracture.

• MRI should be the advanced imaging of choice for diagnosis of presumed hip fracture not apparent on initial radiographs.

• Hip fracture surgery should be performed within 48 hours of admission.

• An interdisciplinary care program should be utilized for patients with mild to moderate dementia who have sustained a hip fracture.

• Supplemental vitamin D and calcium should be given to patients following hip fracture surgery.

• Patients should be evaluated and treated for osteoporosis after sustaining a hip fracture.

To read the entire guideline document, click here: www.aaos.org/research/guidelines/HipFxGuideline.pdf.

The American Academy of Orthopaedic Surgeons’ new guideline on the diagnosis and treatment of hip fractures in elderly patients targets problem areas such as postoperative delirium and pain management.

The clinical practice guideline, “Management of Hip Fractures in the Elderly,” addresses hip fractures in patients age 65 years and older and offers recommendations on issues such as the timing of surgery and the use of vitamin D.

© iStock / ThinkStockPhotos.com

The AAOS also hopes the guideline will expose gaps in the body of research literature that should be addressed in future studies. The guideline has been endorsed by the American Geriatrics Society, the U.S. Bone and Joint Initiative, the Orthopaedic Trauma Association, the American Association of Clinical Endocrinologists, and the Hip Society.

The guideline’s recommendations include:

• Regional analgesia should be used to improve preoperative pain control in patients with hip fracture.

• MRI should be the advanced imaging of choice for diagnosis of presumed hip fracture not apparent on initial radiographs.

• Hip fracture surgery should be performed within 48 hours of admission.

• An interdisciplinary care program should be utilized for patients with mild to moderate dementia who have sustained a hip fracture.

• Supplemental vitamin D and calcium should be given to patients following hip fracture surgery.

• Patients should be evaluated and treated for osteoporosis after sustaining a hip fracture.

To read the entire guideline document, click here: www.aaos.org/research/guidelines/HipFxGuideline.pdf.

The American Academy of Orthopaedic Surgeons’ new guideline on the diagnosis and treatment of hip fractures in elderly patients targets problem areas such as postoperative delirium and pain management.

The clinical practice guideline, “Management of Hip Fractures in the Elderly,” addresses hip fractures in patients age 65 years and older and offers recommendations on issues such as the timing of surgery and the use of vitamin D.

© iStock / ThinkStockPhotos.com

The AAOS also hopes the guideline will expose gaps in the body of research literature that should be addressed in future studies. The guideline has been endorsed by the American Geriatrics Society, the U.S. Bone and Joint Initiative, the Orthopaedic Trauma Association, the American Association of Clinical Endocrinologists, and the Hip Society.

The guideline’s recommendations include:

• Regional analgesia should be used to improve preoperative pain control in patients with hip fracture.

• MRI should be the advanced imaging of choice for diagnosis of presumed hip fracture not apparent on initial radiographs.

• Hip fracture surgery should be performed within 48 hours of admission.

• An interdisciplinary care program should be utilized for patients with mild to moderate dementia who have sustained a hip fracture.

• Supplemental vitamin D and calcium should be given to patients following hip fracture surgery.

• Patients should be evaluated and treated for osteoporosis after sustaining a hip fracture.

To read the entire guideline document, click here: www.aaos.org/research/guidelines/HipFxGuideline.pdf.

Apixaban was the safest anticoagulant used for extended treatment of venous thromboembolism (VTE), according to a network meta-analysis of more than 11.000 patients.

While several anticoagulants significantly reduced the risk of VTE recurrence compared to placebo, only apixaban also did not increase bleeding risk significantly more than placebo. In fact, all active therapies except aspirin increased the risk of composite bleeding by 2-4 times compared to apixaban (2.5 mg), according to Diana M. Sobieraj, Pharm.D., of the University of Connecticut, and her colleagues.

In addition to apixaban (2.5 mg and 5 mg), the other anticoagulants that significantly reduced the risk of VTE recurrence compared to placebo were dabigatran, rivaroxaban, idraparinux, and vitamin K antagonists (VKAs). Of these drugs, idraparinux was least effective and VKAs were most effective at reducing the risk of a recurring VTE,

All of the anticoagulants other than idraparinux significantly reduced VTE risk more than aspirin did, ranging from a 73% reduction, with either apixaban (2.5 mg) or rivaroxaban, to an 80% reduced risk with VKAs.

Whether anticoagulation therapy should be extended for patients with VTE beyond 3 months remains a topic of debate, but results of the analysis “provide additional justification for” doing so, “primarily in patients with unprovoked proximal [VTE] with low to moderate bleeding risk,” the researchers reported.

Find the full study in Thrombosis Research (doi.org/10.1016/j.thromres.2015.02.032)

Apixaban was the safest anticoagulant used for extended treatment of venous thromboembolism (VTE), according to a network meta-analysis of more than 11.000 patients.

While several anticoagulants significantly reduced the risk of VTE recurrence compared to placebo, only apixaban also did not increase bleeding risk significantly more than placebo. In fact, all active therapies except aspirin increased the risk of composite bleeding by 2-4 times compared to apixaban (2.5 mg), according to Diana M. Sobieraj, Pharm.D., of the University of Connecticut, and her colleagues.

In addition to apixaban (2.5 mg and 5 mg), the other anticoagulants that significantly reduced the risk of VTE recurrence compared to placebo were dabigatran, rivaroxaban, idraparinux, and vitamin K antagonists (VKAs). Of these drugs, idraparinux was least effective and VKAs were most effective at reducing the risk of a recurring VTE,

All of the anticoagulants other than idraparinux significantly reduced VTE risk more than aspirin did, ranging from a 73% reduction, with either apixaban (2.5 mg) or rivaroxaban, to an 80% reduced risk with VKAs.

Whether anticoagulation therapy should be extended for patients with VTE beyond 3 months remains a topic of debate, but results of the analysis “provide additional justification for” doing so, “primarily in patients with unprovoked proximal [VTE] with low to moderate bleeding risk,” the researchers reported.

Find the full study in Thrombosis Research (doi.org/10.1016/j.thromres.2015.02.032)

Apixaban was the safest anticoagulant used for extended treatment of venous thromboembolism (VTE), according to a network meta-analysis of more than 11.000 patients.

While several anticoagulants significantly reduced the risk of VTE recurrence compared to placebo, only apixaban also did not increase bleeding risk significantly more than placebo. In fact, all active therapies except aspirin increased the risk of composite bleeding by 2-4 times compared to apixaban (2.5 mg), according to Diana M. Sobieraj, Pharm.D., of the University of Connecticut, and her colleagues.

In addition to apixaban (2.5 mg and 5 mg), the other anticoagulants that significantly reduced the risk of VTE recurrence compared to placebo were dabigatran, rivaroxaban, idraparinux, and vitamin K antagonists (VKAs). Of these drugs, idraparinux was least effective and VKAs were most effective at reducing the risk of a recurring VTE,

All of the anticoagulants other than idraparinux significantly reduced VTE risk more than aspirin did, ranging from a 73% reduction, with either apixaban (2.5 mg) or rivaroxaban, to an 80% reduced risk with VKAs.

Whether anticoagulation therapy should be extended for patients with VTE beyond 3 months remains a topic of debate, but results of the analysis “provide additional justification for” doing so, “primarily in patients with unprovoked proximal [VTE] with low to moderate bleeding risk,” the researchers reported.

Find the full study in Thrombosis Research (doi.org/10.1016/j.thromres.2015.02.032)

ANSWER: A

Critique

While small bowel biopsies are the gold standard test for the exclusion of celiac disease, HLA typing for DQ2 and DQ8 (A) is very useful as an exclusionary test for celiac disease, as the diagnosis is quite unlikely in their absence. DQ2 and DQ8 haplotyping also are useful when small intestinal biopsies are equivocal. Antigliadin antibodies (B & C) do not have particularly high negative predictive values, and have little value here. Also, gluten challenge testing (E) would be of limited utility in excluding the presence of celiac disease.

Reference
1. Liu E., Rewers M., Eisenbarth G.S. Genetic testing: who should do the testing and what is the role of genetic testing in the setting of celiac disease? Gastroenterology 2005;128(4 Suppl 1):S33-7.

ANSWER: A

Critique

While small bowel biopsies are the gold standard test for the exclusion of celiac disease, HLA typing for DQ2 and DQ8 (A) is very useful as an exclusionary test for celiac disease, as the diagnosis is quite unlikely in their absence. DQ2 and DQ8 haplotyping also are useful when small intestinal biopsies are equivocal. Antigliadin antibodies (B & C) do not have particularly high negative predictive values, and have little value here. Also, gluten challenge testing (E) would be of limited utility in excluding the presence of celiac disease.

Reference
1. Liu E., Rewers M., Eisenbarth G.S. Genetic testing: who should do the testing and what is the role of genetic testing in the setting of celiac disease? Gastroenterology 2005;128(4 Suppl 1):S33-7.

ANSWER: A

Critique

While small bowel biopsies are the gold standard test for the exclusion of celiac disease, HLA typing for DQ2 and DQ8 (A) is very useful as an exclusionary test for celiac disease, as the diagnosis is quite unlikely in their absence. DQ2 and DQ8 haplotyping also are useful when small intestinal biopsies are equivocal. Antigliadin antibodies (B & C) do not have particularly high negative predictive values, and have little value here. Also, gluten challenge testing (E) would be of limited utility in excluding the presence of celiac disease.

Reference
1. Liu E., Rewers M., Eisenbarth G.S. Genetic testing: who should do the testing and what is the role of genetic testing in the setting of celiac disease? Gastroenterology 2005;128(4 Suppl 1):S33-7.

ANSWER: C

Critique

The patient in this clinical presentation has symptoms most consistent with cyclic vomiting syndrome (CVS) and has undergone additional testing to exclude luminal pathology. His gastric emptying study is consistent with rapid gastric emptying, which can be seen in 60% of patients with CVS. There is increasing recognition of hyperemesis in the setting of cannabis use, and this may be contributing to this patient’s symptoms. However, prior to recommending that patients stop using cannabis, appropriate treatment for CVS should be instituted. There are several reports that suggest long-term tricyclic antidepressant (TCA) therapy significantly reduces the frequency and duration of CVS episodes, ED visits, and hospitalizations. Although psychiatric disorders are associated with nonresponse to TCA therapy, an appropriate trial of a TCA is warranted prior to referral to psychiatry in the absence of a clear psychological diagnosis. The clinical picture does not suggest small intestinal bacterial overgrowth.

Reference
1. Hejazi R.A., Reddymasu S.C., Namin F., Lavenbarg T., Foran P., McCallum R.W. Efficacy of tricyclic antidepressant therapy in adults with cyclic vomiting syndrome: a two-year follow-up study. J. Clin. Gastroenterol. 2010;44:18-21.

ANSWER: C

Critique

The patient in this clinical presentation has symptoms most consistent with cyclic vomiting syndrome (CVS) and has undergone additional testing to exclude luminal pathology. His gastric emptying study is consistent with rapid gastric emptying, which can be seen in 60% of patients with CVS. There is increasing recognition of hyperemesis in the setting of cannabis use, and this may be contributing to this patient’s symptoms. However, prior to recommending that patients stop using cannabis, appropriate treatment for CVS should be instituted. There are several reports that suggest long-term tricyclic antidepressant (TCA) therapy significantly reduces the frequency and duration of CVS episodes, ED visits, and hospitalizations. Although psychiatric disorders are associated with nonresponse to TCA therapy, an appropriate trial of a TCA is warranted prior to referral to psychiatry in the absence of a clear psychological diagnosis. The clinical picture does not suggest small intestinal bacterial overgrowth.

Reference
1. Hejazi R.A., Reddymasu S.C., Namin F., Lavenbarg T., Foran P., McCallum R.W. Efficacy of tricyclic antidepressant therapy in adults with cyclic vomiting syndrome: a two-year follow-up study. J. Clin. Gastroenterol. 2010;44:18-21.

ANSWER: C

Critique

The patient in this clinical presentation has symptoms most consistent with cyclic vomiting syndrome (CVS) and has undergone additional testing to exclude luminal pathology. His gastric emptying study is consistent with rapid gastric emptying, which can be seen in 60% of patients with CVS. There is increasing recognition of hyperemesis in the setting of cannabis use, and this may be contributing to this patient’s symptoms. However, prior to recommending that patients stop using cannabis, appropriate treatment for CVS should be instituted. There are several reports that suggest long-term tricyclic antidepressant (TCA) therapy significantly reduces the frequency and duration of CVS episodes, ED visits, and hospitalizations. Although psychiatric disorders are associated with nonresponse to TCA therapy, an appropriate trial of a TCA is warranted prior to referral to psychiatry in the absence of a clear psychological diagnosis. The clinical picture does not suggest small intestinal bacterial overgrowth.

Reference
1. Hejazi R.A., Reddymasu S.C., Namin F., Lavenbarg T., Foran P., McCallum R.W. Efficacy of tricyclic antidepressant therapy in adults with cyclic vomiting syndrome: a two-year follow-up study. J. Clin. Gastroenterol. 2010;44:18-21.

Gout is inversely associated with the risk of developing Alzheimer’s disease, and uric acid may play a neuroprotective role, according to a study published March 4 in Annals of the Rheumatic Diseases. Researchers conducted a study using data from the Health Improvement Network, an electronic medical record database that is representative of the United Kingdom’s general population. Investigators identified 309 new cases of Alzheimer’s disease among 59,224 patients with gout (average age, 65) and 1,942 cases of Alzheimer’s disease among 238,805 people in the comparison group over a five-year follow up. After accounting for age, sex, BMI, socioeconomic status, lifestyle factors, prior heart conditions, and use of heart drugs, people with a history of gout had a 24% lower risk of developing Alzheimer’s disease.

In patients with ST-segment elevation myocardial infarction who are undergoing primary percutaneous coronary intervention (PCI), routine manual thrombectomy may not reduce the risk of cardiovascular death, compared with PCI alone, according to a study published online ahead of print March 16 in New England Journal of Medicine. In a randomized controlled trial that involved 10,732 patients at 87 hospitals in 20 countries, half of participants received PCI alone and half received PCI with manual thrombectomy. Death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or heart failure occurred within 180 days in 6.9% of the thrombectomy group and 7% of the PCI-alone group. “The message from this study is that thrombectomy should not be used as a routine strategy,” the researchers stated.

A broad range of pre-existing mental disorders are associated with the subsequent onset of severe or frequent headaches, according to a study published in the January issue of Journal of Pain. Researchers evaluated data from 19 World Health Organization World Mental Health Surveys completed by more than 50,000 subjects. The investigators looked at the association between pre-existing mood, anxiety, impulse control, and substance use disorders with subsequent onset of frequent or severe headaches. After adjusting for sex, age, and mental disorder comorbidity, the researchers found that mood, anxiety, and impulse control disorders increased the likelihood of developing severe and frequent headaches by 40%. Respondents with early-onset pre-existing mental disorders had a 21% higher risk for developing headaches than people with later-onset mental disorders.

Early symptoms of post-traumatic stress, such as anxiety, emotional numbness, flashbacks, and irritability, are the strongest predictors of later disability, according to a study published online ahead of print March 4 in Brain. The trial included 38 service members diagnosed with blast-related concussive traumatic brain injury and 34 service members without brain injury who volunteered to serve as controls. Early assessments of service members were conducted in Afghanistan during the first week after injury. Follow-up mental health assessments were conducted with standard interviews at six to 12 months afterward. Sixty-three percent of patients with brain injury were classified as moderately disabled, compared with 20% of people in the control group. The remaining 37% of the brain injury group were considered to have a good recovery.

Among teenagers, heavy marijuana use is associated with an abnormally shaped hippocampus and poor performance on long-term memory tasks, according to a study published online ahead of print March 11 in Hippocampus. Researchers examined 97 people, including matched groups of healthy controls, subjects with a marijuana use disorder, people with schizophrenia and no history of substance use disorders, and people with schizophrenia and a marijuana use disorder. Participants had started using marijuana daily between ages 16 and 17 and continued for about three years. Overall, the longer participants used marijuana, the more abnormal the shape of their hippocampus became. Young adults with schizophrenia who abused cannabis as teens also performed about 26% more poorly on memory tests than young adults with schizophrenia who never abused cannabis.

The combination of enalapril and folic acid, compared with enalapril alone, significantly reduces the risk of a first stroke in adults with hypertension, according to a study published online ahead of print March 15 in JAMA. Researchers randomized 20,702 adults with hypertension and no history of stroke or heart attack to daily treatment with a single-pill combination containing 10 mg of enalapril and 0.8 mg of folic acid or to a tablet containing 10 mg of enalapril alone. During a median treatment duration of 4.5 years, first stroke occurred in 282 participants in the enalapril–folic acid group, compared with 355 participants in the enalapril group. Analyses also showed significant reductions in the risk of ischemic stroke and cardiovascular events among participants in the enalapril– folic acid group.

Responsive direct cortical stimulation safely and effectively reduces seizures in adults with medically refractory partial onset seizures, according to a study published February 24 in Neurology. The results are part of an ongoing, seven-year, multicenter, prospective, open-label study to evaluate the long-term efficacy and safety of the RNS System. A total of 256 participants were implanted with the neurostimulator and leads. Seizure frequency decreased in the majority of participants treated with responsive stimulation. The median percent reduction in seizures was 44% at one year and 53% at two years postimplant. The median percent reduction in seizures was 60% at the beginning of year three and 66% at the beginning of year six. The responder rates at the same time points were 58% and 59%, respectively.

Persistent insomnia is associated with increased risk for all-cause and cardiopulmonary mortality and a steeper increase in inflammation, according to a study published March 12 in American Journal of Medicine. Researchers assessed the persistence of insomnia complaints in 1,409 adult participants from the Tucson Epidemiological Study of Airway Obstructive Disease. The study began in 1972 and included multiple follow-up surveys until 1996 and continuous mortality follow-up data until 2011. Using data from the survey from 1972 through 1973 and from the 1990 through 1992 follow-up survey, the researchers found that serum C-reactive protein (CRP) levels increased over time in people with persistent insomnia. In those subjects for whom CRP data were available, persistent insomnia was associated with a 58% increase in mortality risk, after adjustments for confounding factors.

Prolonged sleep is a potentially useful marker to determine increased future stroke risk in a healthy aging population, according to a study published online ahead of print February 25 in Neurology. Researchers followed 9,692 people with a mean age of 62 who had never had a stroke. Participants were asked about their sleeping habits once and then again four years later. The participants were followed for an average of 9.5 years, and 346 people had a stroke. Of the 986 people who slept more than eight hours per night, 52 had a stroke, compared with 211 of the 6,684 people who slept an average amount. The relationship between long sleep and stroke remained the same after researchers accounted for high cholesterol, high blood pressure, physical activity, and BMI.

Higher levels of physical activity may reduce the effects of white matter hyperintensity burden on motor function in healthy older adults, according to a study published online ahead of print March 11 in Neurology. Researchers examined 167 people (average age, 80) who wore movement monitors on their wrists for as long as 11 days to measure exercise and nonexercise activity. Participants also took 11 motor performance tests. For the people in the top 10% of activity, greater amounts of brain damage did not influence scores on the movement tests. However, for people in the less active half of the population, greater amounts of brain damage were associated with lower scores on the movement tests. For all participants, the average score on the movement tests was 1.04.

Patients with Parkinson’s disease have reduced low- and high-contrast visual acuity, compared with controls, according to a study published January 1 in Journal of Parkinson’s Disease. Thirty-two patients with Parkinson’s disease and 71 control subjects underwent a neurologic examination, which included the Unified Parkinson’s Disease Rating Scale and vision testing using the Variable Contrast Acuity Chart displayed on an iPad. The chart was displayed at low and high contrast at distances of 40 cm and 2 m. Based on the number of letters correctly identified, patients with Parkinson’s disease saw about 10% fewer letters than control subjects in the low-contrast tests at either distance and in the high-contrast tests at 2 m. Researchers found no significant difference between Parkinson’s disease and control subjects in the high-contrast testing at 40 cm.

Statins may not lower the risk for Parkinson’s disease, according to a study published online ahead of print January 14 in Movement Disorders. The researchers examined blood cholesterol levels, medications, and Parkinson’s disease status in participants in the ongoing, long-term Atherosclerosis Risk in Communities study. Cholesterol readings were taken at three-year intervals between 1987 and 1998. Statin use before 1998 was associated with significantly higher risk of Parkinson’s disease after 1998. Higher total cholesterol, however, was associated with lower risk for Parkinson’s disease after adjustment for statin use and confounders. Compared with the lowest tertile of average total cholesterol, the odds ratios for Parkinson’s disease were 0.56 for the second tertile and 0.43 for the third tertile. These data are inconsistent with the hypothesis that statins protect against Parkinson’s disease.

—Kimberly Williams

Gout is inversely associated with the risk of developing Alzheimer’s disease, and uric acid may play a neuroprotective role, according to a study published March 4 in Annals of the Rheumatic Diseases. Researchers conducted a study using data from the Health Improvement Network, an electronic medical record database that is representative of the United Kingdom’s general population. Investigators identified 309 new cases of Alzheimer’s disease among 59,224 patients with gout (average age, 65) and 1,942 cases of Alzheimer’s disease among 238,805 people in the comparison group over a five-year follow up. After accounting for age, sex, BMI, socioeconomic status, lifestyle factors, prior heart conditions, and use of heart drugs, people with a history of gout had a 24% lower risk of developing Alzheimer’s disease.

In patients with ST-segment elevation myocardial infarction who are undergoing primary percutaneous coronary intervention (PCI), routine manual thrombectomy may not reduce the risk of cardiovascular death, compared with PCI alone, according to a study published online ahead of print March 16 in New England Journal of Medicine. In a randomized controlled trial that involved 10,732 patients at 87 hospitals in 20 countries, half of participants received PCI alone and half received PCI with manual thrombectomy. Death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or heart failure occurred within 180 days in 6.9% of the thrombectomy group and 7% of the PCI-alone group. “The message from this study is that thrombectomy should not be used as a routine strategy,” the researchers stated.

A broad range of pre-existing mental disorders are associated with the subsequent onset of severe or frequent headaches, according to a study published in the January issue of Journal of Pain. Researchers evaluated data from 19 World Health Organization World Mental Health Surveys completed by more than 50,000 subjects. The investigators looked at the association between pre-existing mood, anxiety, impulse control, and substance use disorders with subsequent onset of frequent or severe headaches. After adjusting for sex, age, and mental disorder comorbidity, the researchers found that mood, anxiety, and impulse control disorders increased the likelihood of developing severe and frequent headaches by 40%. Respondents with early-onset pre-existing mental disorders had a 21% higher risk for developing headaches than people with later-onset mental disorders.

Early symptoms of post-traumatic stress, such as anxiety, emotional numbness, flashbacks, and irritability, are the strongest predictors of later disability, according to a study published online ahead of print March 4 in Brain. The trial included 38 service members diagnosed with blast-related concussive traumatic brain injury and 34 service members without brain injury who volunteered to serve as controls. Early assessments of service members were conducted in Afghanistan during the first week after injury. Follow-up mental health assessments were conducted with standard interviews at six to 12 months afterward. Sixty-three percent of patients with brain injury were classified as moderately disabled, compared with 20% of people in the control group. The remaining 37% of the brain injury group were considered to have a good recovery.

Among teenagers, heavy marijuana use is associated with an abnormally shaped hippocampus and poor performance on long-term memory tasks, according to a study published online ahead of print March 11 in Hippocampus. Researchers examined 97 people, including matched groups of healthy controls, subjects with a marijuana use disorder, people with schizophrenia and no history of substance use disorders, and people with schizophrenia and a marijuana use disorder. Participants had started using marijuana daily between ages 16 and 17 and continued for about three years. Overall, the longer participants used marijuana, the more abnormal the shape of their hippocampus became. Young adults with schizophrenia who abused cannabis as teens also performed about 26% more poorly on memory tests than young adults with schizophrenia who never abused cannabis.

The combination of enalapril and folic acid, compared with enalapril alone, significantly reduces the risk of a first stroke in adults with hypertension, according to a study published online ahead of print March 15 in JAMA. Researchers randomized 20,702 adults with hypertension and no history of stroke or heart attack to daily treatment with a single-pill combination containing 10 mg of enalapril and 0.8 mg of folic acid or to a tablet containing 10 mg of enalapril alone. During a median treatment duration of 4.5 years, first stroke occurred in 282 participants in the enalapril–folic acid group, compared with 355 participants in the enalapril group. Analyses also showed significant reductions in the risk of ischemic stroke and cardiovascular events among participants in the enalapril– folic acid group.

Responsive direct cortical stimulation safely and effectively reduces seizures in adults with medically refractory partial onset seizures, according to a study published February 24 in Neurology. The results are part of an ongoing, seven-year, multicenter, prospective, open-label study to evaluate the long-term efficacy and safety of the RNS System. A total of 256 participants were implanted with the neurostimulator and leads. Seizure frequency decreased in the majority of participants treated with responsive stimulation. The median percent reduction in seizures was 44% at one year and 53% at two years postimplant. The median percent reduction in seizures was 60% at the beginning of year three and 66% at the beginning of year six. The responder rates at the same time points were 58% and 59%, respectively.

Persistent insomnia is associated with increased risk for all-cause and cardiopulmonary mortality and a steeper increase in inflammation, according to a study published March 12 in American Journal of Medicine. Researchers assessed the persistence of insomnia complaints in 1,409 adult participants from the Tucson Epidemiological Study of Airway Obstructive Disease. The study began in 1972 and included multiple follow-up surveys until 1996 and continuous mortality follow-up data until 2011. Using data from the survey from 1972 through 1973 and from the 1990 through 1992 follow-up survey, the researchers found that serum C-reactive protein (CRP) levels increased over time in people with persistent insomnia. In those subjects for whom CRP data were available, persistent insomnia was associated with a 58% increase in mortality risk, after adjustments for confounding factors.

Prolonged sleep is a potentially useful marker to determine increased future stroke risk in a healthy aging population, according to a study published online ahead of print February 25 in Neurology. Researchers followed 9,692 people with a mean age of 62 who had never had a stroke. Participants were asked about their sleeping habits once and then again four years later. The participants were followed for an average of 9.5 years, and 346 people had a stroke. Of the 986 people who slept more than eight hours per night, 52 had a stroke, compared with 211 of the 6,684 people who slept an average amount. The relationship between long sleep and stroke remained the same after researchers accounted for high cholesterol, high blood pressure, physical activity, and BMI.

Higher levels of physical activity may reduce the effects of white matter hyperintensity burden on motor function in healthy older adults, according to a study published online ahead of print March 11 in Neurology. Researchers examined 167 people (average age, 80) who wore movement monitors on their wrists for as long as 11 days to measure exercise and nonexercise activity. Participants also took 11 motor performance tests. For the people in the top 10% of activity, greater amounts of brain damage did not influence scores on the movement tests. However, for people in the less active half of the population, greater amounts of brain damage were associated with lower scores on the movement tests. For all participants, the average score on the movement tests was 1.04.

Patients with Parkinson’s disease have reduced low- and high-contrast visual acuity, compared with controls, according to a study published January 1 in Journal of Parkinson’s Disease. Thirty-two patients with Parkinson’s disease and 71 control subjects underwent a neurologic examination, which included the Unified Parkinson’s Disease Rating Scale and vision testing using the Variable Contrast Acuity Chart displayed on an iPad. The chart was displayed at low and high contrast at distances of 40 cm and 2 m. Based on the number of letters correctly identified, patients with Parkinson’s disease saw about 10% fewer letters than control subjects in the low-contrast tests at either distance and in the high-contrast tests at 2 m. Researchers found no significant difference between Parkinson’s disease and control subjects in the high-contrast testing at 40 cm.

Statins may not lower the risk for Parkinson’s disease, according to a study published online ahead of print January 14 in Movement Disorders. The researchers examined blood cholesterol levels, medications, and Parkinson’s disease status in participants in the ongoing, long-term Atherosclerosis Risk in Communities study. Cholesterol readings were taken at three-year intervals between 1987 and 1998. Statin use before 1998 was associated with significantly higher risk of Parkinson’s disease after 1998. Higher total cholesterol, however, was associated with lower risk for Parkinson’s disease after adjustment for statin use and confounders. Compared with the lowest tertile of average total cholesterol, the odds ratios for Parkinson’s disease were 0.56 for the second tertile and 0.43 for the third tertile. These data are inconsistent with the hypothesis that statins protect against Parkinson’s disease.

—Kimberly Williams

Gout is inversely associated with the risk of developing Alzheimer’s disease, and uric acid may play a neuroprotective role, according to a study published March 4 in Annals of the Rheumatic Diseases. Researchers conducted a study using data from the Health Improvement Network, an electronic medical record database that is representative of the United Kingdom’s general population. Investigators identified 309 new cases of Alzheimer’s disease among 59,224 patients with gout (average age, 65) and 1,942 cases of Alzheimer’s disease among 238,805 people in the comparison group over a five-year follow up. After accounting for age, sex, BMI, socioeconomic status, lifestyle factors, prior heart conditions, and use of heart drugs, people with a history of gout had a 24% lower risk of developing Alzheimer’s disease.

In patients with ST-segment elevation myocardial infarction who are undergoing primary percutaneous coronary intervention (PCI), routine manual thrombectomy may not reduce the risk of cardiovascular death, compared with PCI alone, according to a study published online ahead of print March 16 in New England Journal of Medicine. In a randomized controlled trial that involved 10,732 patients at 87 hospitals in 20 countries, half of participants received PCI alone and half received PCI with manual thrombectomy. Death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or heart failure occurred within 180 days in 6.9% of the thrombectomy group and 7% of the PCI-alone group. “The message from this study is that thrombectomy should not be used as a routine strategy,” the researchers stated.

A broad range of pre-existing mental disorders are associated with the subsequent onset of severe or frequent headaches, according to a study published in the January issue of Journal of Pain. Researchers evaluated data from 19 World Health Organization World Mental Health Surveys completed by more than 50,000 subjects. The investigators looked at the association between pre-existing mood, anxiety, impulse control, and substance use disorders with subsequent onset of frequent or severe headaches. After adjusting for sex, age, and mental disorder comorbidity, the researchers found that mood, anxiety, and impulse control disorders increased the likelihood of developing severe and frequent headaches by 40%. Respondents with early-onset pre-existing mental disorders had a 21% higher risk for developing headaches than people with later-onset mental disorders.

Early symptoms of post-traumatic stress, such as anxiety, emotional numbness, flashbacks, and irritability, are the strongest predictors of later disability, according to a study published online ahead of print March 4 in Brain. The trial included 38 service members diagnosed with blast-related concussive traumatic brain injury and 34 service members without brain injury who volunteered to serve as controls. Early assessments of service members were conducted in Afghanistan during the first week after injury. Follow-up mental health assessments were conducted with standard interviews at six to 12 months afterward. Sixty-three percent of patients with brain injury were classified as moderately disabled, compared with 20% of people in the control group. The remaining 37% of the brain injury group were considered to have a good recovery.

Among teenagers, heavy marijuana use is associated with an abnormally shaped hippocampus and poor performance on long-term memory tasks, according to a study published online ahead of print March 11 in Hippocampus. Researchers examined 97 people, including matched groups of healthy controls, subjects with a marijuana use disorder, people with schizophrenia and no history of substance use disorders, and people with schizophrenia and a marijuana use disorder. Participants had started using marijuana daily between ages 16 and 17 and continued for about three years. Overall, the longer participants used marijuana, the more abnormal the shape of their hippocampus became. Young adults with schizophrenia who abused cannabis as teens also performed about 26% more poorly on memory tests than young adults with schizophrenia who never abused cannabis.

The combination of enalapril and folic acid, compared with enalapril alone, significantly reduces the risk of a first stroke in adults with hypertension, according to a study published online ahead of print March 15 in JAMA. Researchers randomized 20,702 adults with hypertension and no history of stroke or heart attack to daily treatment with a single-pill combination containing 10 mg of enalapril and 0.8 mg of folic acid or to a tablet containing 10 mg of enalapril alone. During a median treatment duration of 4.5 years, first stroke occurred in 282 participants in the enalapril–folic acid group, compared with 355 participants in the enalapril group. Analyses also showed significant reductions in the risk of ischemic stroke and cardiovascular events among participants in the enalapril– folic acid group.

Responsive direct cortical stimulation safely and effectively reduces seizures in adults with medically refractory partial onset seizures, according to a study published February 24 in Neurology. The results are part of an ongoing, seven-year, multicenter, prospective, open-label study to evaluate the long-term efficacy and safety of the RNS System. A total of 256 participants were implanted with the neurostimulator and leads. Seizure frequency decreased in the majority of participants treated with responsive stimulation. The median percent reduction in seizures was 44% at one year and 53% at two years postimplant. The median percent reduction in seizures was 60% at the beginning of year three and 66% at the beginning of year six. The responder rates at the same time points were 58% and 59%, respectively.

Persistent insomnia is associated with increased risk for all-cause and cardiopulmonary mortality and a steeper increase in inflammation, according to a study published March 12 in American Journal of Medicine. Researchers assessed the persistence of insomnia complaints in 1,409 adult participants from the Tucson Epidemiological Study of Airway Obstructive Disease. The study began in 1972 and included multiple follow-up surveys until 1996 and continuous mortality follow-up data until 2011. Using data from the survey from 1972 through 1973 and from the 1990 through 1992 follow-up survey, the researchers found that serum C-reactive protein (CRP) levels increased over time in people with persistent insomnia. In those subjects for whom CRP data were available, persistent insomnia was associated with a 58% increase in mortality risk, after adjustments for confounding factors.

Prolonged sleep is a potentially useful marker to determine increased future stroke risk in a healthy aging population, according to a study published online ahead of print February 25 in Neurology. Researchers followed 9,692 people with a mean age of 62 who had never had a stroke. Participants were asked about their sleeping habits once and then again four years later. The participants were followed for an average of 9.5 years, and 346 people had a stroke. Of the 986 people who slept more than eight hours per night, 52 had a stroke, compared with 211 of the 6,684 people who slept an average amount. The relationship between long sleep and stroke remained the same after researchers accounted for high cholesterol, high blood pressure, physical activity, and BMI.

Higher levels of physical activity may reduce the effects of white matter hyperintensity burden on motor function in healthy older adults, according to a study published online ahead of print March 11 in Neurology. Researchers examined 167 people (average age, 80) who wore movement monitors on their wrists for as long as 11 days to measure exercise and nonexercise activity. Participants also took 11 motor performance tests. For the people in the top 10% of activity, greater amounts of brain damage did not influence scores on the movement tests. However, for people in the less active half of the population, greater amounts of brain damage were associated with lower scores on the movement tests. For all participants, the average score on the movement tests was 1.04.

Patients with Parkinson’s disease have reduced low- and high-contrast visual acuity, compared with controls, according to a study published January 1 in Journal of Parkinson’s Disease. Thirty-two patients with Parkinson’s disease and 71 control subjects underwent a neurologic examination, which included the Unified Parkinson’s Disease Rating Scale and vision testing using the Variable Contrast Acuity Chart displayed on an iPad. The chart was displayed at low and high contrast at distances of 40 cm and 2 m. Based on the number of letters correctly identified, patients with Parkinson’s disease saw about 10% fewer letters than control subjects in the low-contrast tests at either distance and in the high-contrast tests at 2 m. Researchers found no significant difference between Parkinson’s disease and control subjects in the high-contrast testing at 40 cm.

Statins may not lower the risk for Parkinson’s disease, according to a study published online ahead of print January 14 in Movement Disorders. The researchers examined blood cholesterol levels, medications, and Parkinson’s disease status in participants in the ongoing, long-term Atherosclerosis Risk in Communities study. Cholesterol readings were taken at three-year intervals between 1987 and 1998. Statin use before 1998 was associated with significantly higher risk of Parkinson’s disease after 1998. Higher total cholesterol, however, was associated with lower risk for Parkinson’s disease after adjustment for statin use and confounders. Compared with the lowest tertile of average total cholesterol, the odds ratios for Parkinson’s disease were 0.56 for the second tertile and 0.43 for the third tertile. These data are inconsistent with the hypothesis that statins protect against Parkinson’s disease.

—Kimberly Williams