The Food and Drug Administration has approved a once-a-day treatment for patients aged 13 years and older with ADHD, Shire announced June 20 in a press release.

The approval of Mydayis was based on results from 16 clinical studies evaluating the medication in more than 1,600 adolescents (aged 13-17 years) and adults with attention-deficit/hyperactivity disorder. In the placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents. Improvement on the PERMP reached statistical significance beginning at 2 or 4 hours post dose and lasting up to 16 hours post dose.

[email protected]

The Food and Drug Administration has approved a once-a-day treatment for patients aged 13 years and older with ADHD, Shire announced June 20 in a press release.

The approval of Mydayis was based on results from 16 clinical studies evaluating the medication in more than 1,600 adolescents (aged 13-17 years) and adults with attention-deficit/hyperactivity disorder. In the placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents. Improvement on the PERMP reached statistical significance beginning at 2 or 4 hours post dose and lasting up to 16 hours post dose.

[email protected]

The Food and Drug Administration has approved a once-a-day treatment for patients aged 13 years and older with ADHD, Shire announced June 20 in a press release.

The approval of Mydayis was based on results from 16 clinical studies evaluating the medication in more than 1,600 adolescents (aged 13-17 years) and adults with attention-deficit/hyperactivity disorder. In the placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents. Improvement on the PERMP reached statistical significance beginning at 2 or 4 hours post dose and lasting up to 16 hours post dose.

[email protected]

LAS VEGAS – A variety of evidence-based strategies are available for preventing posttraumatic knee osteoarthritis (KOA) in patients who have already sustained an anterior cruciate ligament (ACL) injury. And they’re generally ignored, according to May Arna Risberg, PhD.

“We have a lot of knowledge. We can use secondary prevention strategies. And here I think we, as physical therapists, physicians, and orthopedic surgeons, are doing a lousy job because we are sending these ACL-injured patients back to sports before they have normalized knee function and quadriceps strength,” said Dr. Risberg, professor of sports medicine at the Norwegian School of Sport Sciences in Oslo.

With no proven disease-modifying therapy for KOA available to date, secondary prevention of posttraumatic KOA is worthy of high-priority status, she said at the World Congress on Osteoarthritis. An estimated 250,00 ACL injuries occur annually in the United States, and up to one-half of affected patients, most of whom are young, active people, will experience a second ACL rupture within the first few years after undergoing their initial reconstruction. This second ACL injury greatly increases their risk of developing posttraumatic KOA within 15-20 years, while they are still relatively young, she said.

Moreover, if the second ACL injury involves meniscus surgery, the 5-year risk of posttraumatic KOA roughly triples to up to 48%.

She highlighted a few effective strategies for preventing posttraumatic KOA in patients who already have an ACL injury.

Avoid reinjury

Dr. Risberg was senior author of a recent report from the prospective Delaware-Oslo Cohort Study involving 106 athletes who underwent ACL reconstruction following injury in what she termed level I sports. These are sports that entail lots of pivoting, jumping, and hard cutting, such as basketball, soccer, and handball.

In the first 2 years after ACL repair, 30% of patients who returned to participation in a level 1 sport experienced an ACL reinjury, compared with just 8% who opted for a lower-level sport. Athletes who returned to a level 1 sport had an adjusted 4.3 times greater ACL reinjury rate than those who didn’t, Dr. Risberg noted at the congress sponsored by the Osteoarthritis Research Society International.

The good news is that this sharply increased reinjury risk was mitigated if return to a level 1 sport was delayed for at least 9 months post surgery and if the patient had regained quadriceps strength comparable to the uninjured side. For every month that return to sport was delayed out until 9 months post ACL reconstruction, the knee reinjury rate was reduced by 51% (Br J Sports Med. 2016;50:804-8).

In a meta-analysis by other investigators of 12 studies including 5,707 participants, weakness of the knee extensor muscles was independently associated with a 1.65 times increased risk of developing KOA (Osteoarthritis Cartilage. 2015 Feb;23[2]:171-7).

Attend to BMI

A discussion of the importance of maintaining a healthy body weight is an important aspect of patient education for athletes with knee injuries. In a cohort study of 988 patients who underwent primary ACL reconstruction, being overweight or obese was associated with a significantly increased risk of subsequent meniscal tears and chondral lesions (Am J Sports Med. 2015 Dec;43[12]:2966-73).

Also, it’s well established that obesity is a risk factor for knee OA, and Canadian investigators have shown that young athletes with a sports-related intra-articular knee injury were 3.75 times more likely to be overweight or obese 3-10 years post injury, compared with matched uninjured controls (Osteoarthritis Cartilage. 2015 Jul;23[7]:1122-9).

Consider prehabilitative exercise training

Dr. Risberg and coinvestigators have reported that preoperative quadriceps muscle strength deficits are predictive of impaired knee function, as measured by the Cincinnati Knee Score 2 years post surgery. She said she believes ACL reconstruction shouldn’t be done until quadriceps muscle strength is at least 80% of that in the uninjured limb (Br J Sports Med. 2009 May;43[5]:371-6). She and her coinvestigators have published the details of a 5-week progressive exercise therapy program in which they have shown results in significantly improved early postoperative knee function (J Orthop Sports Phys Ther. 2010 Nov;40[11]:705-21). They now try to have patients complete the twice-weekly, 5-week program before final decisions are reached regarding whether to have ACL reconstruction.

Test all before okaying return to sport

It’s important to know if patients who have undergone ACL reconstruction have gotten full knee function back before determining if they’re ready for full-on sports participation. In the Delaware-Oslo Cohort Study, patients who delayed their return until at least 9 months after surgery and passed the return-to-sports test had a 5.6% reinjury rate within 2 years, while those who failed the return-to-sports criteria had a 38.2% ACL reinjury rate.

The return-to-sports testing utilized in this study entailed isokinetic quadriceps strength testing, the single hop leg test, the 14-item self-rated Knee Outcome Survey–Activities of Daily Living Scale, and a self-rated Global Rating Scale of perceived function on a 0-100 scale. To be cleared for return to sports, a patient had to demonstrate having regained at least 90% of quadriceps muscle strength and hop performance along with scoring in the normative range on both of the self-rating instruments.

Surgical vs. nonsurgical treatment of ACL rupture

The evidence on this score is conflicting, according to Dr. Risberg. While most physical therapists believe ACL reconstruction doesn’t protect against later development of KOA, as reflected in a meta-analysis of published studies (J Bone Joint Surg Am. 2014 Feb 19;96[4]:292-300), a more recent retrospective comparison of 964 patients with an isolated ACL tear and an equal number of matched controls concluded that patients treated nonoperatively were six times more likely to have been diagnosed with KOA and 16.7 times more likely to have undergone total knee replacement at a mean follow-up of 13.7 years than were those treated with ACL reconstruction (Am J Sports Med. 2016 Jul;44[7]:1699-707).

Dr. Risberg’s fellow panelist Jackie Whittaker, PhD, said that, as long as quadriceps muscle strengthening is a priority, it makes sense to strengthen the hamstring as well, particularly if the ACL reconstruction utilized the hamstring tendon.

“Also, I would add that it’s important to develop a relationship with these ACL-injured people, who are often very young. Preventing a disease that they’re going to get 20 years later isn’t a priority for them. You need to develop that relationship and build it up over time. Helping them set realistic expectations is very important. And we need to do what we can to help them find some sort of competitive outlet. A lot of these kids were very competitive, and now they’ve had an injury and can’t compete. They don’t want to go back to playing just any sport. They want to be able to be competitive, and if you don’t help them find another way to express that, they sort of give up on physical activity altogether,” according to Dr. Whittaker of the University of Alberta in Edmonton.

Dr. Risberg and Dr. Whittaker reported having no financial conflicts of interest.

[email protected]

LAS VEGAS – A variety of evidence-based strategies are available for preventing posttraumatic knee osteoarthritis (KOA) in patients who have already sustained an anterior cruciate ligament (ACL) injury. And they’re generally ignored, according to May Arna Risberg, PhD.

“We have a lot of knowledge. We can use secondary prevention strategies. And here I think we, as physical therapists, physicians, and orthopedic surgeons, are doing a lousy job because we are sending these ACL-injured patients back to sports before they have normalized knee function and quadriceps strength,” said Dr. Risberg, professor of sports medicine at the Norwegian School of Sport Sciences in Oslo.

With no proven disease-modifying therapy for KOA available to date, secondary prevention of posttraumatic KOA is worthy of high-priority status, she said at the World Congress on Osteoarthritis. An estimated 250,00 ACL injuries occur annually in the United States, and up to one-half of affected patients, most of whom are young, active people, will experience a second ACL rupture within the first few years after undergoing their initial reconstruction. This second ACL injury greatly increases their risk of developing posttraumatic KOA within 15-20 years, while they are still relatively young, she said.

Moreover, if the second ACL injury involves meniscus surgery, the 5-year risk of posttraumatic KOA roughly triples to up to 48%.

She highlighted a few effective strategies for preventing posttraumatic KOA in patients who already have an ACL injury.

Avoid reinjury

Dr. Risberg was senior author of a recent report from the prospective Delaware-Oslo Cohort Study involving 106 athletes who underwent ACL reconstruction following injury in what she termed level I sports. These are sports that entail lots of pivoting, jumping, and hard cutting, such as basketball, soccer, and handball.

In the first 2 years after ACL repair, 30% of patients who returned to participation in a level 1 sport experienced an ACL reinjury, compared with just 8% who opted for a lower-level sport. Athletes who returned to a level 1 sport had an adjusted 4.3 times greater ACL reinjury rate than those who didn’t, Dr. Risberg noted at the congress sponsored by the Osteoarthritis Research Society International.

The good news is that this sharply increased reinjury risk was mitigated if return to a level 1 sport was delayed for at least 9 months post surgery and if the patient had regained quadriceps strength comparable to the uninjured side. For every month that return to sport was delayed out until 9 months post ACL reconstruction, the knee reinjury rate was reduced by 51% (Br J Sports Med. 2016;50:804-8).

In a meta-analysis by other investigators of 12 studies including 5,707 participants, weakness of the knee extensor muscles was independently associated with a 1.65 times increased risk of developing KOA (Osteoarthritis Cartilage. 2015 Feb;23[2]:171-7).

Attend to BMI

A discussion of the importance of maintaining a healthy body weight is an important aspect of patient education for athletes with knee injuries. In a cohort study of 988 patients who underwent primary ACL reconstruction, being overweight or obese was associated with a significantly increased risk of subsequent meniscal tears and chondral lesions (Am J Sports Med. 2015 Dec;43[12]:2966-73).

Also, it’s well established that obesity is a risk factor for knee OA, and Canadian investigators have shown that young athletes with a sports-related intra-articular knee injury were 3.75 times more likely to be overweight or obese 3-10 years post injury, compared with matched uninjured controls (Osteoarthritis Cartilage. 2015 Jul;23[7]:1122-9).

Consider prehabilitative exercise training

Dr. Risberg and coinvestigators have reported that preoperative quadriceps muscle strength deficits are predictive of impaired knee function, as measured by the Cincinnati Knee Score 2 years post surgery. She said she believes ACL reconstruction shouldn’t be done until quadriceps muscle strength is at least 80% of that in the uninjured limb (Br J Sports Med. 2009 May;43[5]:371-6). She and her coinvestigators have published the details of a 5-week progressive exercise therapy program in which they have shown results in significantly improved early postoperative knee function (J Orthop Sports Phys Ther. 2010 Nov;40[11]:705-21). They now try to have patients complete the twice-weekly, 5-week program before final decisions are reached regarding whether to have ACL reconstruction.

Test all before okaying return to sport

It’s important to know if patients who have undergone ACL reconstruction have gotten full knee function back before determining if they’re ready for full-on sports participation. In the Delaware-Oslo Cohort Study, patients who delayed their return until at least 9 months after surgery and passed the return-to-sports test had a 5.6% reinjury rate within 2 years, while those who failed the return-to-sports criteria had a 38.2% ACL reinjury rate.

The return-to-sports testing utilized in this study entailed isokinetic quadriceps strength testing, the single hop leg test, the 14-item self-rated Knee Outcome Survey–Activities of Daily Living Scale, and a self-rated Global Rating Scale of perceived function on a 0-100 scale. To be cleared for return to sports, a patient had to demonstrate having regained at least 90% of quadriceps muscle strength and hop performance along with scoring in the normative range on both of the self-rating instruments.

Surgical vs. nonsurgical treatment of ACL rupture

The evidence on this score is conflicting, according to Dr. Risberg. While most physical therapists believe ACL reconstruction doesn’t protect against later development of KOA, as reflected in a meta-analysis of published studies (J Bone Joint Surg Am. 2014 Feb 19;96[4]:292-300), a more recent retrospective comparison of 964 patients with an isolated ACL tear and an equal number of matched controls concluded that patients treated nonoperatively were six times more likely to have been diagnosed with KOA and 16.7 times more likely to have undergone total knee replacement at a mean follow-up of 13.7 years than were those treated with ACL reconstruction (Am J Sports Med. 2016 Jul;44[7]:1699-707).

Dr. Risberg’s fellow panelist Jackie Whittaker, PhD, said that, as long as quadriceps muscle strengthening is a priority, it makes sense to strengthen the hamstring as well, particularly if the ACL reconstruction utilized the hamstring tendon.

“Also, I would add that it’s important to develop a relationship with these ACL-injured people, who are often very young. Preventing a disease that they’re going to get 20 years later isn’t a priority for them. You need to develop that relationship and build it up over time. Helping them set realistic expectations is very important. And we need to do what we can to help them find some sort of competitive outlet. A lot of these kids were very competitive, and now they’ve had an injury and can’t compete. They don’t want to go back to playing just any sport. They want to be able to be competitive, and if you don’t help them find another way to express that, they sort of give up on physical activity altogether,” according to Dr. Whittaker of the University of Alberta in Edmonton.

Dr. Risberg and Dr. Whittaker reported having no financial conflicts of interest.

[email protected]

LAS VEGAS – A variety of evidence-based strategies are available for preventing posttraumatic knee osteoarthritis (KOA) in patients who have already sustained an anterior cruciate ligament (ACL) injury. And they’re generally ignored, according to May Arna Risberg, PhD.

“We have a lot of knowledge. We can use secondary prevention strategies. And here I think we, as physical therapists, physicians, and orthopedic surgeons, are doing a lousy job because we are sending these ACL-injured patients back to sports before they have normalized knee function and quadriceps strength,” said Dr. Risberg, professor of sports medicine at the Norwegian School of Sport Sciences in Oslo.

With no proven disease-modifying therapy for KOA available to date, secondary prevention of posttraumatic KOA is worthy of high-priority status, she said at the World Congress on Osteoarthritis. An estimated 250,00 ACL injuries occur annually in the United States, and up to one-half of affected patients, most of whom are young, active people, will experience a second ACL rupture within the first few years after undergoing their initial reconstruction. This second ACL injury greatly increases their risk of developing posttraumatic KOA within 15-20 years, while they are still relatively young, she said.

Moreover, if the second ACL injury involves meniscus surgery, the 5-year risk of posttraumatic KOA roughly triples to up to 48%.

She highlighted a few effective strategies for preventing posttraumatic KOA in patients who already have an ACL injury.

Avoid reinjury

Dr. Risberg was senior author of a recent report from the prospective Delaware-Oslo Cohort Study involving 106 athletes who underwent ACL reconstruction following injury in what she termed level I sports. These are sports that entail lots of pivoting, jumping, and hard cutting, such as basketball, soccer, and handball.

In the first 2 years after ACL repair, 30% of patients who returned to participation in a level 1 sport experienced an ACL reinjury, compared with just 8% who opted for a lower-level sport. Athletes who returned to a level 1 sport had an adjusted 4.3 times greater ACL reinjury rate than those who didn’t, Dr. Risberg noted at the congress sponsored by the Osteoarthritis Research Society International.

The good news is that this sharply increased reinjury risk was mitigated if return to a level 1 sport was delayed for at least 9 months post surgery and if the patient had regained quadriceps strength comparable to the uninjured side. For every month that return to sport was delayed out until 9 months post ACL reconstruction, the knee reinjury rate was reduced by 51% (Br J Sports Med. 2016;50:804-8).

In a meta-analysis by other investigators of 12 studies including 5,707 participants, weakness of the knee extensor muscles was independently associated with a 1.65 times increased risk of developing KOA (Osteoarthritis Cartilage. 2015 Feb;23[2]:171-7).

Attend to BMI

A discussion of the importance of maintaining a healthy body weight is an important aspect of patient education for athletes with knee injuries. In a cohort study of 988 patients who underwent primary ACL reconstruction, being overweight or obese was associated with a significantly increased risk of subsequent meniscal tears and chondral lesions (Am J Sports Med. 2015 Dec;43[12]:2966-73).

Also, it’s well established that obesity is a risk factor for knee OA, and Canadian investigators have shown that young athletes with a sports-related intra-articular knee injury were 3.75 times more likely to be overweight or obese 3-10 years post injury, compared with matched uninjured controls (Osteoarthritis Cartilage. 2015 Jul;23[7]:1122-9).

Consider prehabilitative exercise training

Dr. Risberg and coinvestigators have reported that preoperative quadriceps muscle strength deficits are predictive of impaired knee function, as measured by the Cincinnati Knee Score 2 years post surgery. She said she believes ACL reconstruction shouldn’t be done until quadriceps muscle strength is at least 80% of that in the uninjured limb (Br J Sports Med. 2009 May;43[5]:371-6). She and her coinvestigators have published the details of a 5-week progressive exercise therapy program in which they have shown results in significantly improved early postoperative knee function (J Orthop Sports Phys Ther. 2010 Nov;40[11]:705-21). They now try to have patients complete the twice-weekly, 5-week program before final decisions are reached regarding whether to have ACL reconstruction.

Test all before okaying return to sport

It’s important to know if patients who have undergone ACL reconstruction have gotten full knee function back before determining if they’re ready for full-on sports participation. In the Delaware-Oslo Cohort Study, patients who delayed their return until at least 9 months after surgery and passed the return-to-sports test had a 5.6% reinjury rate within 2 years, while those who failed the return-to-sports criteria had a 38.2% ACL reinjury rate.

The return-to-sports testing utilized in this study entailed isokinetic quadriceps strength testing, the single hop leg test, the 14-item self-rated Knee Outcome Survey–Activities of Daily Living Scale, and a self-rated Global Rating Scale of perceived function on a 0-100 scale. To be cleared for return to sports, a patient had to demonstrate having regained at least 90% of quadriceps muscle strength and hop performance along with scoring in the normative range on both of the self-rating instruments.

Surgical vs. nonsurgical treatment of ACL rupture

The evidence on this score is conflicting, according to Dr. Risberg. While most physical therapists believe ACL reconstruction doesn’t protect against later development of KOA, as reflected in a meta-analysis of published studies (J Bone Joint Surg Am. 2014 Feb 19;96[4]:292-300), a more recent retrospective comparison of 964 patients with an isolated ACL tear and an equal number of matched controls concluded that patients treated nonoperatively were six times more likely to have been diagnosed with KOA and 16.7 times more likely to have undergone total knee replacement at a mean follow-up of 13.7 years than were those treated with ACL reconstruction (Am J Sports Med. 2016 Jul;44[7]:1699-707).

Dr. Risberg’s fellow panelist Jackie Whittaker, PhD, said that, as long as quadriceps muscle strengthening is a priority, it makes sense to strengthen the hamstring as well, particularly if the ACL reconstruction utilized the hamstring tendon.

“Also, I would add that it’s important to develop a relationship with these ACL-injured people, who are often very young. Preventing a disease that they’re going to get 20 years later isn’t a priority for them. You need to develop that relationship and build it up over time. Helping them set realistic expectations is very important. And we need to do what we can to help them find some sort of competitive outlet. A lot of these kids were very competitive, and now they’ve had an injury and can’t compete. They don’t want to go back to playing just any sport. They want to be able to be competitive, and if you don’t help them find another way to express that, they sort of give up on physical activity altogether,” according to Dr. Whittaker of the University of Alberta in Edmonton.

Dr. Risberg and Dr. Whittaker reported having no financial conflicts of interest.

[email protected]

Every patient who is initially diagnosed with epilepsy should also be evaluated for coexisting psychiatric problems, according to Andres Kanner with the Department of Neurology, University of Miami School of Medicine. Kanner noted that psychiatric comorbidities often existed in patients before they were diagnosed with a seizure. That, coupled with the fact that drug therapy and surgery for epilepsy often cause psychiatric symptoms, is part of the justification for conducting these evaluations.

Kanner AM. Psychiatric comorbidities in new onset epilepsy: Should they be always investigated? Seizure. 2017;49:79-82.

Every patient who is initially diagnosed with epilepsy should also be evaluated for coexisting psychiatric problems, according to Andres Kanner with the Department of Neurology, University of Miami School of Medicine. Kanner noted that psychiatric comorbidities often existed in patients before they were diagnosed with a seizure. That, coupled with the fact that drug therapy and surgery for epilepsy often cause psychiatric symptoms, is part of the justification for conducting these evaluations.

Kanner AM. Psychiatric comorbidities in new onset epilepsy: Should they be always investigated? Seizure. 2017;49:79-82.

Every patient who is initially diagnosed with epilepsy should also be evaluated for coexisting psychiatric problems, according to Andres Kanner with the Department of Neurology, University of Miami School of Medicine. Kanner noted that psychiatric comorbidities often existed in patients before they were diagnosed with a seizure. That, coupled with the fact that drug therapy and surgery for epilepsy often cause psychiatric symptoms, is part of the justification for conducting these evaluations.

Kanner AM. Psychiatric comorbidities in new onset epilepsy: Should they be always investigated? Seizure. 2017;49:79-82.

Although a recent analysis of adverse effects (AEs) found differences between AEs reported for generic versions compared with brand name versions of the 3 common antiepileptic drugs (AEDs), when approved generic formulations were compared to unapproved generics, reporting odds ratios were similar for authorized generic AEDs and generic AEDs. The researchers concluded that the differences were the result of perception biases. There were differences in drug AE reports of suicide and suicide ideation between authorized generic and brand name drugs that could not be explained by bias.

Rahman MM, Alatawi Y, Cheng N, et al. Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) [published online June 3, 2017]. Epilepsy Res. doi: http://dx.doi.org/10.1016/j.eplepsyres.2017.06.007

Although a recent analysis of adverse effects (AEs) found differences between AEs reported for generic versions compared with brand name versions of the 3 common antiepileptic drugs (AEDs), when approved generic formulations were compared to unapproved generics, reporting odds ratios were similar for authorized generic AEDs and generic AEDs. The researchers concluded that the differences were the result of perception biases. There were differences in drug AE reports of suicide and suicide ideation between authorized generic and brand name drugs that could not be explained by bias.

Rahman MM, Alatawi Y, Cheng N, et al. Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) [published online June 3, 2017]. Epilepsy Res. doi: http://dx.doi.org/10.1016/j.eplepsyres.2017.06.007

Although a recent analysis of adverse effects (AEs) found differences between AEs reported for generic versions compared with brand name versions of the 3 common antiepileptic drugs (AEDs), when approved generic formulations were compared to unapproved generics, reporting odds ratios were similar for authorized generic AEDs and generic AEDs. The researchers concluded that the differences were the result of perception biases. There were differences in drug AE reports of suicide and suicide ideation between authorized generic and brand name drugs that could not be explained by bias.

Rahman MM, Alatawi Y, Cheng N, et al. Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) [published online June 3, 2017]. Epilepsy Res. doi: http://dx.doi.org/10.1016/j.eplepsyres.2017.06.007

The likelihood of experiencing a recurrent seizure is closely linked to a person’s stress level, according to a recent study that looked at 52 individuals with a single unprovoked seizure and 29 with newly diagnosed epilepsy. The researchers, who looked at adult residents in low-income areas of Northern Manhattan and Harlem, New York City, found that generalized anxiety disorder increased the risk of a recurrent seizure threefold. In a second analysis, a mood disorder more than doubled the risk of a recurrent seizure.    

Baldin E, Hauser WS, Pack A, Hesdorffer DC. Stress is associated with an increased risk of recurrent seizures in adults. Epilepsia. 2017;58:1037-1046.

The likelihood of experiencing a recurrent seizure is closely linked to a person’s stress level, according to a recent study that looked at 52 individuals with a single unprovoked seizure and 29 with newly diagnosed epilepsy. The researchers, who looked at adult residents in low-income areas of Northern Manhattan and Harlem, New York City, found that generalized anxiety disorder increased the risk of a recurrent seizure threefold. In a second analysis, a mood disorder more than doubled the risk of a recurrent seizure.    

Baldin E, Hauser WS, Pack A, Hesdorffer DC. Stress is associated with an increased risk of recurrent seizures in adults. Epilepsia. 2017;58:1037-1046.

The likelihood of experiencing a recurrent seizure is closely linked to a person’s stress level, according to a recent study that looked at 52 individuals with a single unprovoked seizure and 29 with newly diagnosed epilepsy. The researchers, who looked at adult residents in low-income areas of Northern Manhattan and Harlem, New York City, found that generalized anxiety disorder increased the risk of a recurrent seizure threefold. In a second analysis, a mood disorder more than doubled the risk of a recurrent seizure.    

Baldin E, Hauser WS, Pack A, Hesdorffer DC. Stress is associated with an increased risk of recurrent seizures in adults. Epilepsia. 2017;58:1037-1046.

SAN DIEGO – Treating systolic hypertension to a target of 120 mm Hg instead of 140 mm Hg significantly reduced the rate of cardiovascular events in high-risk patients with prediabetes, according to a post-hoc analysis of the multicenter, randomized, controlled, open-label Systolic Blood Pressure Intervention Trial (SPRINT).

Thus, prediabetes did not undercut the cardiovascular benefits of intensive systolic blood pressure (SBP) control in older, high-risk, hypertensive patients, Adam P. Bress, PharmD, MS, and his associates concluded in a late-breaking poster presented at the annual scientific sessions of the American Diabetes Association.

SAN DIEGO – Treating systolic hypertension to a target of 120 mm Hg instead of 140 mm Hg significantly reduced the rate of cardiovascular events in high-risk patients with prediabetes, according to a post-hoc analysis of the multicenter, randomized, controlled, open-label Systolic Blood Pressure Intervention Trial (SPRINT).

Thus, prediabetes did not undercut the cardiovascular benefits of intensive systolic blood pressure (SBP) control in older, high-risk, hypertensive patients, Adam P. Bress, PharmD, MS, and his associates concluded in a late-breaking poster presented at the annual scientific sessions of the American Diabetes Association.

SAN DIEGO – Treating systolic hypertension to a target of 120 mm Hg instead of 140 mm Hg significantly reduced the rate of cardiovascular events in high-risk patients with prediabetes, according to a post-hoc analysis of the multicenter, randomized, controlled, open-label Systolic Blood Pressure Intervention Trial (SPRINT).

Thus, prediabetes did not undercut the cardiovascular benefits of intensive systolic blood pressure (SBP) control in older, high-risk, hypertensive patients, Adam P. Bress, PharmD, MS, and his associates concluded in a late-breaking poster presented at the annual scientific sessions of the American Diabetes Association.

Three members of the hospital medicine community – Thiruvoipati Nanda Kumar, MD; Anthony Aghenta, MD, MS, FACP; and Angela Aboutalib, MD – recently were honored for their work by the International Association of HealthCare Professionals, earning spots in its publication, The Leading Physicians of the World.

Hospitalist and internist Dr. Nanda Kumar serves patients at Vibra Hospital in Redding, Calif., where he is also a clinical associate professor at the University of California at Davis. He is a member of both the Society of Hospital Medicine and the American Diabetes Association.

Dr. Aghenta is a 17-year veteran internist who currently serves as medical director for Coronado Healthcare Center in Phoenix. There, he also is affiliated with St. Joseph’s Hospital and Medical Center. A member of SHM, Dr. Aghenta also has the title of Fellow of the American College of Physicians.

Dr. Aboutalib, whose experience as an internist includes expertise in hospital medicine, serves as hospitalist and medical director of clinical operations at U.S. Acute Care Solutions, Canton, Ohio. Previously, this member of the American College of Physicians served South Physicians as a hospitalist at Mercy Hospital in Chicago.
 

Andrew Dunn, MD, MPH, FACP, SFHM, recently was named chair-elect of the Board of Regents of the American College of Physicians (ACP), the national organization of internists. He assumed the role at the start of the ACP’s annual scientific meeting held in San Diego, March 30–April 1.

Susan Herson, MD, has been named the new chief of staff at the Bath, N.Y., Veterans Affairs Medical Center. Dr. Herson comes to Bath from the Sioux Falls (S.D.) VA, where she was a hospitalist, a hospitalist-clinician educator, and medical director of clinical documentation improvement, while also serving as clinical assistant professor for New York Medical College and medical director at Norwalk (Conn.) Hospital.

Dr. Herson served in the U.S. Navy, doing her training at Walter Reed Medical Center, Bethesda, Md. She was a general medical officer while stationed at U.S. Marine Corps Base Camp Lejeune in Jacksonville, N.C.
 

Chad Whelan, MD, has been elevated to president of the Loyola (Ill.) University Medical Center, moving up from his chair as senior vice president and chief medical officer. This longtime hospitalist also serves as a professor of medicine in the Loyola Chicago Stritch School of Medicine.

Kevin Tulipana, DO, recently was promoted to medical director of hospital medicine at Cancer Treatment Centers of America’s Southwest Regional Medical Center in Tulsa, Okla. Previously, Dr. Tulipana was a hospitalist in the special care unit at CTCA Tulsa.

Mustafa Sardini, MD, has been named Envision Physician Services’ 2017 Hospital Medicine Physician of the Year. Dr. Sardini is the site medical director as Baylor Scott & White Medical Center, Sunnyvale, Texas. EPS presents the award to a hospitalist who peers deem as a leader in the industry.
 

Business moves

Physicians’ Alliance, (PAL) recently announced plans to partner with Penn State Health. As the largest independent physician group in Lancaster County, Pa., they will bring its more than 120 physicians, hospitalists, and dieticians to central Pennsylvania giant Penn State.

The alliance will allow patients of PAL physicians access to advanced care at Milton S. Hershey Medical Center and Penn State Children’s Hospital in Hershey.
 

Envision Healthcare, Greenwood Village, Colo. has created the Envision Physical Services (EPS) as a result of a merger with AmSurg ambulatory surgical center in December 2016. EPS combines EmCare and Sheridan Healthcare’s physician services divisions.

EPS specializes in hospital medicine, anesthesia, emergency medicine, radiology, and surgical services.

Three members of the hospital medicine community – Thiruvoipati Nanda Kumar, MD; Anthony Aghenta, MD, MS, FACP; and Angela Aboutalib, MD – recently were honored for their work by the International Association of HealthCare Professionals, earning spots in its publication, The Leading Physicians of the World.

Hospitalist and internist Dr. Nanda Kumar serves patients at Vibra Hospital in Redding, Calif., where he is also a clinical associate professor at the University of California at Davis. He is a member of both the Society of Hospital Medicine and the American Diabetes Association.

Dr. Aghenta is a 17-year veteran internist who currently serves as medical director for Coronado Healthcare Center in Phoenix. There, he also is affiliated with St. Joseph’s Hospital and Medical Center. A member of SHM, Dr. Aghenta also has the title of Fellow of the American College of Physicians.

Dr. Aboutalib, whose experience as an internist includes expertise in hospital medicine, serves as hospitalist and medical director of clinical operations at U.S. Acute Care Solutions, Canton, Ohio. Previously, this member of the American College of Physicians served South Physicians as a hospitalist at Mercy Hospital in Chicago.
 

Andrew Dunn, MD, MPH, FACP, SFHM, recently was named chair-elect of the Board of Regents of the American College of Physicians (ACP), the national organization of internists. He assumed the role at the start of the ACP’s annual scientific meeting held in San Diego, March 30–April 1.

Susan Herson, MD, has been named the new chief of staff at the Bath, N.Y., Veterans Affairs Medical Center. Dr. Herson comes to Bath from the Sioux Falls (S.D.) VA, where she was a hospitalist, a hospitalist-clinician educator, and medical director of clinical documentation improvement, while also serving as clinical assistant professor for New York Medical College and medical director at Norwalk (Conn.) Hospital.

Dr. Herson served in the U.S. Navy, doing her training at Walter Reed Medical Center, Bethesda, Md. She was a general medical officer while stationed at U.S. Marine Corps Base Camp Lejeune in Jacksonville, N.C.
 

Chad Whelan, MD, has been elevated to president of the Loyola (Ill.) University Medical Center, moving up from his chair as senior vice president and chief medical officer. This longtime hospitalist also serves as a professor of medicine in the Loyola Chicago Stritch School of Medicine.

Kevin Tulipana, DO, recently was promoted to medical director of hospital medicine at Cancer Treatment Centers of America’s Southwest Regional Medical Center in Tulsa, Okla. Previously, Dr. Tulipana was a hospitalist in the special care unit at CTCA Tulsa.

Mustafa Sardini, MD, has been named Envision Physician Services’ 2017 Hospital Medicine Physician of the Year. Dr. Sardini is the site medical director as Baylor Scott & White Medical Center, Sunnyvale, Texas. EPS presents the award to a hospitalist who peers deem as a leader in the industry.
 

Business moves

Physicians’ Alliance, (PAL) recently announced plans to partner with Penn State Health. As the largest independent physician group in Lancaster County, Pa., they will bring its more than 120 physicians, hospitalists, and dieticians to central Pennsylvania giant Penn State.

The alliance will allow patients of PAL physicians access to advanced care at Milton S. Hershey Medical Center and Penn State Children’s Hospital in Hershey.
 

Envision Healthcare, Greenwood Village, Colo. has created the Envision Physical Services (EPS) as a result of a merger with AmSurg ambulatory surgical center in December 2016. EPS combines EmCare and Sheridan Healthcare’s physician services divisions.

EPS specializes in hospital medicine, anesthesia, emergency medicine, radiology, and surgical services.

Three members of the hospital medicine community – Thiruvoipati Nanda Kumar, MD; Anthony Aghenta, MD, MS, FACP; and Angela Aboutalib, MD – recently were honored for their work by the International Association of HealthCare Professionals, earning spots in its publication, The Leading Physicians of the World.

Hospitalist and internist Dr. Nanda Kumar serves patients at Vibra Hospital in Redding, Calif., where he is also a clinical associate professor at the University of California at Davis. He is a member of both the Society of Hospital Medicine and the American Diabetes Association.

Dr. Aghenta is a 17-year veteran internist who currently serves as medical director for Coronado Healthcare Center in Phoenix. There, he also is affiliated with St. Joseph’s Hospital and Medical Center. A member of SHM, Dr. Aghenta also has the title of Fellow of the American College of Physicians.

Dr. Aboutalib, whose experience as an internist includes expertise in hospital medicine, serves as hospitalist and medical director of clinical operations at U.S. Acute Care Solutions, Canton, Ohio. Previously, this member of the American College of Physicians served South Physicians as a hospitalist at Mercy Hospital in Chicago.
 

Andrew Dunn, MD, MPH, FACP, SFHM, recently was named chair-elect of the Board of Regents of the American College of Physicians (ACP), the national organization of internists. He assumed the role at the start of the ACP’s annual scientific meeting held in San Diego, March 30–April 1.

Susan Herson, MD, has been named the new chief of staff at the Bath, N.Y., Veterans Affairs Medical Center. Dr. Herson comes to Bath from the Sioux Falls (S.D.) VA, where she was a hospitalist, a hospitalist-clinician educator, and medical director of clinical documentation improvement, while also serving as clinical assistant professor for New York Medical College and medical director at Norwalk (Conn.) Hospital.

Dr. Herson served in the U.S. Navy, doing her training at Walter Reed Medical Center, Bethesda, Md. She was a general medical officer while stationed at U.S. Marine Corps Base Camp Lejeune in Jacksonville, N.C.
 

Chad Whelan, MD, has been elevated to president of the Loyola (Ill.) University Medical Center, moving up from his chair as senior vice president and chief medical officer. This longtime hospitalist also serves as a professor of medicine in the Loyola Chicago Stritch School of Medicine.

Kevin Tulipana, DO, recently was promoted to medical director of hospital medicine at Cancer Treatment Centers of America’s Southwest Regional Medical Center in Tulsa, Okla. Previously, Dr. Tulipana was a hospitalist in the special care unit at CTCA Tulsa.

Mustafa Sardini, MD, has been named Envision Physician Services’ 2017 Hospital Medicine Physician of the Year. Dr. Sardini is the site medical director as Baylor Scott & White Medical Center, Sunnyvale, Texas. EPS presents the award to a hospitalist who peers deem as a leader in the industry.
 

Business moves

Physicians’ Alliance, (PAL) recently announced plans to partner with Penn State Health. As the largest independent physician group in Lancaster County, Pa., they will bring its more than 120 physicians, hospitalists, and dieticians to central Pennsylvania giant Penn State.

The alliance will allow patients of PAL physicians access to advanced care at Milton S. Hershey Medical Center and Penn State Children’s Hospital in Hershey.
 

Envision Healthcare, Greenwood Village, Colo. has created the Envision Physical Services (EPS) as a result of a merger with AmSurg ambulatory surgical center in December 2016. EPS combines EmCare and Sheridan Healthcare’s physician services divisions.

EPS specializes in hospital medicine, anesthesia, emergency medicine, radiology, and surgical services.

CHICAGO – A total annual surgeon volume of fewer than 25 operations was associated with increased 1-year mortality and reoperation rates, according to a study presented at the 2017 American Association for Thoracic Surgery Centennial.

Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes, Joanna Chikwe, MD, and her colleagues at the Icahn School of Medicine at Mount Sinai, New York, stated.

[email protected]

CHICAGO – A total annual surgeon volume of fewer than 25 operations was associated with increased 1-year mortality and reoperation rates, according to a study presented at the 2017 American Association for Thoracic Surgery Centennial.

Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes, Joanna Chikwe, MD, and her colleagues at the Icahn School of Medicine at Mount Sinai, New York, stated.

[email protected]

CHICAGO – A total annual surgeon volume of fewer than 25 operations was associated with increased 1-year mortality and reoperation rates, according to a study presented at the 2017 American Association for Thoracic Surgery Centennial.

Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes, Joanna Chikwe, MD, and her colleagues at the Icahn School of Medicine at Mount Sinai, New York, stated.

[email protected]

This month, our “Flashback” article highlights Congress’s long-term attempt to repeal the Sustainable Growth Rate formula for physician reimbursement and base our payments on patient health outcomes. Although the Medicare Access and Quality Improvement Act of 2013 (highlighted in our 2013 article) sponsored by Rep. Michael Burgess and passed unanimously in the House of Representatives did not become law, it did set the stage for the passage of H.R.2 – the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Also sponsored by Rep. Burgess and passed with bipartisan support, MACRA has now become the foundation for our transition from fee-for-service reimbursement to value-based care.

In just 2 short years, we have all become familiar with terms like MIPS (Merit-based Incentive Payment System) and APMs (Alternative Payment Models). These two methods of reimbursement will become the backbone of a growing percentage of our revenue going forward. Gastroenterologists should embrace these programs and work to find our unique position in the health care value chain.

Larry R. Kosinski, MD, MBA, AGAF, FACG, is a managing partner of Illinois Gastroenterology Group, the Clinical Private Practice Councillor for the AGA, and serves on its Governing Board. He is president and chief medical officer of Project Sonar and an Associate Editor of GI & Hepatology News.

This month, our “Flashback” article highlights Congress’s long-term attempt to repeal the Sustainable Growth Rate formula for physician reimbursement and base our payments on patient health outcomes. Although the Medicare Access and Quality Improvement Act of 2013 (highlighted in our 2013 article) sponsored by Rep. Michael Burgess and passed unanimously in the House of Representatives did not become law, it did set the stage for the passage of H.R.2 – the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Also sponsored by Rep. Burgess and passed with bipartisan support, MACRA has now become the foundation for our transition from fee-for-service reimbursement to value-based care.

In just 2 short years, we have all become familiar with terms like MIPS (Merit-based Incentive Payment System) and APMs (Alternative Payment Models). These two methods of reimbursement will become the backbone of a growing percentage of our revenue going forward. Gastroenterologists should embrace these programs and work to find our unique position in the health care value chain.

Larry R. Kosinski, MD, MBA, AGAF, FACG, is a managing partner of Illinois Gastroenterology Group, the Clinical Private Practice Councillor for the AGA, and serves on its Governing Board. He is president and chief medical officer of Project Sonar and an Associate Editor of GI & Hepatology News.

This month, our “Flashback” article highlights Congress’s long-term attempt to repeal the Sustainable Growth Rate formula for physician reimbursement and base our payments on patient health outcomes. Although the Medicare Access and Quality Improvement Act of 2013 (highlighted in our 2013 article) sponsored by Rep. Michael Burgess and passed unanimously in the House of Representatives did not become law, it did set the stage for the passage of H.R.2 – the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Also sponsored by Rep. Burgess and passed with bipartisan support, MACRA has now become the foundation for our transition from fee-for-service reimbursement to value-based care.

In just 2 short years, we have all become familiar with terms like MIPS (Merit-based Incentive Payment System) and APMs (Alternative Payment Models). These two methods of reimbursement will become the backbone of a growing percentage of our revenue going forward. Gastroenterologists should embrace these programs and work to find our unique position in the health care value chain.

Larry R. Kosinski, MD, MBA, AGAF, FACG, is a managing partner of Illinois Gastroenterology Group, the Clinical Private Practice Councillor for the AGA, and serves on its Governing Board. He is president and chief medical officer of Project Sonar and an Associate Editor of GI & Hepatology News.

SAN DIEGO – A year of treatment with once-weekly exenatide and once-daily dapagliflozin significantly outperformed either therapy alone for patients whose type 2 diabetes was uncontrolled on metformin, investigators reported at the annual scientific sessions of the American Diabetes Association.

At week 52, hemoglobin A_1c, fasting and 2-hour postprandial glucose levels, body weight, and systolic blood pressure improved significantly more in the exenatide/dapagliflozin arm than in the dapagliflozin/placebo arm in the multicenter randomized, double-blind, phase III DURATION-8 trial, Cristian Guja, MD, said in a late-breaking poster. Exenatide/dapagliflozin also topped dapagliflozin/placebo on glycemic outcomes but not on measures of body weight or blood pressure.

Exenatide (Byetta, AstraZeneca) is a glucagon-like peptide–1 (GLP-1) receptor agonist, while dapagliflozin (Farxiga, AstraZeneca) is a sodium-glucose cotransporter–2 (SGLT-2) inhibitor. For the study, Dr. Guja and coinvestigators randomly assigned patients with type 2 diabetes and HbA_1c levels of 8%-12% despite metformin therapy to receive one of three regimens: exenatide once weekly (2-mg subcutaneous injection) plus dapagliflozin (10-mg oral tablet), exenatide with daily placebo tablets, or dapagliflozin with weekly injected placebo. Between weeks 8 and 28, patients received rescue therapy with basal insulin according to progressively stricter fasting plasma glucose criteria that culminated at 200 mg/dL. From weeks 36 to 52, patients received rescue therapy if their HbA_1c level exceeded 8%.

A total of 695 patients were randomized to one of the three study arms, and 564 (81%) patients completed 1 year of treatment. Improvements at 1 year resembled those at week 28. Between baseline and week 52, HbA_1c levels fell by an average of 1.75% in the exenatide/dapagliflozin arm, 0.37% more than with exenatide/placebo (P less than .01) and 0.52% more than with dapagliflozin/placebo (P less than .01). Combination therapy also cut mean fasting plasma glucose levels by 63 mg/dL, which was 18 mg/dL more than with exenatide/placebo (P less than .001) and 23 mg/dL more than with dapagliflozin/placebo (P less than .001). Two-hour postprandial glucose levels dropped by 82 mg/dL with dual therapy, 18.4 mg/dL more than with exenatide/placebo (P less than .01), and 23 mg/dL more than with dapagliflozin/placebo (P less than .001). Recipients of dual therapy also lost an average of 3.3 kg over a period of 1 year and cut their systolic blood pressure by a mean of 4.5 mm, reductions that significantly exceeded those with exenatide/placebo but not with dapagliflozin/placebo.

Proportionally fewer patients needed rescue therapy in the dual-treatment arm (27%), compared with the exenatide/placebo arm (32%) or the dapagliflozin/placebo arm (38%). Most patients needed rescue therapy because their HbA1c levels exceeded 8%, not because their fasting glucose level exceeded 200 mg/dL, Dr. Guja said.

Combination therapy was “well tolerated, with no unexpected adverse events,” Dr. Guja reported. At 52 weeks, the groups had similar rates of serious adverse events, gastrointestinal adverse events, and adverse events leading to treatment discontinuation. In each arm, about 4% of patients stopped treatment because of adverse events. Dual therapy was associated with slightly higher rates of injection-site nodules (9%) and headaches (6%), compared with exenatide or dapagliflozin alone. There were no cases of severe hypoglycemia or acute renal failure. Glomerular filtration rates dropped by an average of 2 mL/ min per 1.73 m² after 1 year of exenatide/dapagliflozin, by 1.2 mL/min per 1.73 m² with exenatide/placebo, and by 0.8 mL/min per 1.73 m² with dapagliflozin/placebo.

Baseline characteristics were similar between groups in DURATION-8. Glycated hemoglobin levels averaged 9.3% in each arm, fasting plasma glucose averaged 195-198 mg/dL, body mass index averaged 32-33 kg/m², and systolic blood pressure averaged 130 mm Hg.

AstraZeneca markets Byetta and Farxiga and sponsored the trial. Dr. Guja reported having been on a speakers bureau for AstraZeneca, and she disclosed ties to several other pharmaceutical companies.

SAN DIEGO – A year of treatment with once-weekly exenatide and once-daily dapagliflozin significantly outperformed either therapy alone for patients whose type 2 diabetes was uncontrolled on metformin, investigators reported at the annual scientific sessions of the American Diabetes Association.

At week 52, hemoglobin A_1c, fasting and 2-hour postprandial glucose levels, body weight, and systolic blood pressure improved significantly more in the exenatide/dapagliflozin arm than in the dapagliflozin/placebo arm in the multicenter randomized, double-blind, phase III DURATION-8 trial, Cristian Guja, MD, said in a late-breaking poster. Exenatide/dapagliflozin also topped dapagliflozin/placebo on glycemic outcomes but not on measures of body weight or blood pressure.

Exenatide (Byetta, AstraZeneca) is a glucagon-like peptide–1 (GLP-1) receptor agonist, while dapagliflozin (Farxiga, AstraZeneca) is a sodium-glucose cotransporter–2 (SGLT-2) inhibitor. For the study, Dr. Guja and coinvestigators randomly assigned patients with type 2 diabetes and HbA_1c levels of 8%-12% despite metformin therapy to receive one of three regimens: exenatide once weekly (2-mg subcutaneous injection) plus dapagliflozin (10-mg oral tablet), exenatide with daily placebo tablets, or dapagliflozin with weekly injected placebo. Between weeks 8 and 28, patients received rescue therapy with basal insulin according to progressively stricter fasting plasma glucose criteria that culminated at 200 mg/dL. From weeks 36 to 52, patients received rescue therapy if their HbA_1c level exceeded 8%.

A total of 695 patients were randomized to one of the three study arms, and 564 (81%) patients completed 1 year of treatment. Improvements at 1 year resembled those at week 28. Between baseline and week 52, HbA_1c levels fell by an average of 1.75% in the exenatide/dapagliflozin arm, 0.37% more than with exenatide/placebo (P less than .01) and 0.52% more than with dapagliflozin/placebo (P less than .01). Combination therapy also cut mean fasting plasma glucose levels by 63 mg/dL, which was 18 mg/dL more than with exenatide/placebo (P less than .001) and 23 mg/dL more than with dapagliflozin/placebo (P less than .001). Two-hour postprandial glucose levels dropped by 82 mg/dL with dual therapy, 18.4 mg/dL more than with exenatide/placebo (P less than .01), and 23 mg/dL more than with dapagliflozin/placebo (P less than .001). Recipients of dual therapy also lost an average of 3.3 kg over a period of 1 year and cut their systolic blood pressure by a mean of 4.5 mm, reductions that significantly exceeded those with exenatide/placebo but not with dapagliflozin/placebo.

Proportionally fewer patients needed rescue therapy in the dual-treatment arm (27%), compared with the exenatide/placebo arm (32%) or the dapagliflozin/placebo arm (38%). Most patients needed rescue therapy because their HbA1c levels exceeded 8%, not because their fasting glucose level exceeded 200 mg/dL, Dr. Guja said.

Combination therapy was “well tolerated, with no unexpected adverse events,” Dr. Guja reported. At 52 weeks, the groups had similar rates of serious adverse events, gastrointestinal adverse events, and adverse events leading to treatment discontinuation. In each arm, about 4% of patients stopped treatment because of adverse events. Dual therapy was associated with slightly higher rates of injection-site nodules (9%) and headaches (6%), compared with exenatide or dapagliflozin alone. There were no cases of severe hypoglycemia or acute renal failure. Glomerular filtration rates dropped by an average of 2 mL/ min per 1.73 m² after 1 year of exenatide/dapagliflozin, by 1.2 mL/min per 1.73 m² with exenatide/placebo, and by 0.8 mL/min per 1.73 m² with dapagliflozin/placebo.

Baseline characteristics were similar between groups in DURATION-8. Glycated hemoglobin levels averaged 9.3% in each arm, fasting plasma glucose averaged 195-198 mg/dL, body mass index averaged 32-33 kg/m², and systolic blood pressure averaged 130 mm Hg.

AstraZeneca markets Byetta and Farxiga and sponsored the trial. Dr. Guja reported having been on a speakers bureau for AstraZeneca, and she disclosed ties to several other pharmaceutical companies.

SAN DIEGO – A year of treatment with once-weekly exenatide and once-daily dapagliflozin significantly outperformed either therapy alone for patients whose type 2 diabetes was uncontrolled on metformin, investigators reported at the annual scientific sessions of the American Diabetes Association.

At week 52, hemoglobin A_1c, fasting and 2-hour postprandial glucose levels, body weight, and systolic blood pressure improved significantly more in the exenatide/dapagliflozin arm than in the dapagliflozin/placebo arm in the multicenter randomized, double-blind, phase III DURATION-8 trial, Cristian Guja, MD, said in a late-breaking poster. Exenatide/dapagliflozin also topped dapagliflozin/placebo on glycemic outcomes but not on measures of body weight or blood pressure.

Exenatide (Byetta, AstraZeneca) is a glucagon-like peptide–1 (GLP-1) receptor agonist, while dapagliflozin (Farxiga, AstraZeneca) is a sodium-glucose cotransporter–2 (SGLT-2) inhibitor. For the study, Dr. Guja and coinvestigators randomly assigned patients with type 2 diabetes and HbA_1c levels of 8%-12% despite metformin therapy to receive one of three regimens: exenatide once weekly (2-mg subcutaneous injection) plus dapagliflozin (10-mg oral tablet), exenatide with daily placebo tablets, or dapagliflozin with weekly injected placebo. Between weeks 8 and 28, patients received rescue therapy with basal insulin according to progressively stricter fasting plasma glucose criteria that culminated at 200 mg/dL. From weeks 36 to 52, patients received rescue therapy if their HbA_1c level exceeded 8%.

A total of 695 patients were randomized to one of the three study arms, and 564 (81%) patients completed 1 year of treatment. Improvements at 1 year resembled those at week 28. Between baseline and week 52, HbA_1c levels fell by an average of 1.75% in the exenatide/dapagliflozin arm, 0.37% more than with exenatide/placebo (P less than .01) and 0.52% more than with dapagliflozin/placebo (P less than .01). Combination therapy also cut mean fasting plasma glucose levels by 63 mg/dL, which was 18 mg/dL more than with exenatide/placebo (P less than .001) and 23 mg/dL more than with dapagliflozin/placebo (P less than .001). Two-hour postprandial glucose levels dropped by 82 mg/dL with dual therapy, 18.4 mg/dL more than with exenatide/placebo (P less than .01), and 23 mg/dL more than with dapagliflozin/placebo (P less than .001). Recipients of dual therapy also lost an average of 3.3 kg over a period of 1 year and cut their systolic blood pressure by a mean of 4.5 mm, reductions that significantly exceeded those with exenatide/placebo but not with dapagliflozin/placebo.

Proportionally fewer patients needed rescue therapy in the dual-treatment arm (27%), compared with the exenatide/placebo arm (32%) or the dapagliflozin/placebo arm (38%). Most patients needed rescue therapy because their HbA1c levels exceeded 8%, not because their fasting glucose level exceeded 200 mg/dL, Dr. Guja said.

Combination therapy was “well tolerated, with no unexpected adverse events,” Dr. Guja reported. At 52 weeks, the groups had similar rates of serious adverse events, gastrointestinal adverse events, and adverse events leading to treatment discontinuation. In each arm, about 4% of patients stopped treatment because of adverse events. Dual therapy was associated with slightly higher rates of injection-site nodules (9%) and headaches (6%), compared with exenatide or dapagliflozin alone. There were no cases of severe hypoglycemia or acute renal failure. Glomerular filtration rates dropped by an average of 2 mL/ min per 1.73 m² after 1 year of exenatide/dapagliflozin, by 1.2 mL/min per 1.73 m² with exenatide/placebo, and by 0.8 mL/min per 1.73 m² with dapagliflozin/placebo.

Baseline characteristics were similar between groups in DURATION-8. Glycated hemoglobin levels averaged 9.3% in each arm, fasting plasma glucose averaged 195-198 mg/dL, body mass index averaged 32-33 kg/m², and systolic blood pressure averaged 130 mm Hg.

AstraZeneca markets Byetta and Farxiga and sponsored the trial. Dr. Guja reported having been on a speakers bureau for AstraZeneca, and she disclosed ties to several other pharmaceutical companies.