Kari Oakes

Dual B-cell receptor pathway blockade was tolerable and efficacious for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) who participated in a multicenter phase 1-1b clinical study that added umbralisib to ibrutinib.

The study “is the first successful combination for two drugs targeting the B-cell receptor pathway,” Matthew S. Davids, MD, of the Dana-Farber Cancer Institute in Boston and his colleagues wrote in the Lancet Haematology.

Of the 21 patients with CLL, 90% (n = 19) achieved an overall response (OR), 62% (n = 13) achieved partial response (PR) or PR with lymphocytosis, and 29% (n = 6) achieved complete response (CR). All patients in complete response still had minimal residual disease (MRD) in bone marrow. No CLL patients had progressive disease.

Of the 21 patients with MCL, 67% (n = 14) had an OR, with 19% (n = 4) showing CR and 48% (n = 10) achieving partial response. Three MCL patients (14%) had progressive disease.

Umbralisib is a next-generation phosphoinositide-3-kinase-delta inhibitor that, when added to the Bruton tyrosine kinase inhibitor (BTKi) ibrutinib, offers once-daily oral dosing. The combination affords the possibility of overcoming the resistance that can come with prolonged ibrutinib monotherapy.

A total of 44 patients were enrolled, and 42 patients (21 with CLL and 21 with MCL) received at least one dose of the study drug and were included in the analysis. At enrollment, patients had received a median of two previous therapies.

Diarrhea was the most frequent adverse event, seen in 22 patients (52%), and half of all patients (n = 21) had infections.

Hematologic toxicities included neutropenia, seen in 9 (43%) of the CLL patients and 8 (38%) of the MCL patients; thrombocytopenia, seen in 6 (29%) of the CLL patients and 10 (48%) of the MCL patients; and anemia, seen in 4 (19%) of the CLL and 9 (43%) of the MCL patients. Grade 3 and 4 hematologic toxicities of any type were less common, occurring in less than 20% of patients. One MCL patient developed febrile neutropenia. According to the study investigators, none of the hematologic toxicities were deemed related to the study drugs.

Adverse events did not appear to be dose-dependent for umbralisib, with the maximum tolerated dose not reached in the study, the investigators wrote. For phase 2 trials, the recommended dose of umbralisib is 800 mg given orally once daily in combination with ibrutinib.

“One unanticipated benefit of doublet B-cell receptor pathway inhibition in this study was the ability to continue one drug when a characteristic toxicity required the other drug to be held,” the investigators wrote.

For MCL patients, 67% achieved OR and 19% achieved CR, figures similar to those reported for ibrutinib monotherapy. However, “the 2-year progression-free survival of 49% and overall survival of 58% suggest that patients who made it to 1 year progression-free had few events during the second year on therapy,” the investigators wrote. They also noted that this MCL population was high risk; more than one-quarter of patients had relapsed after prior autologous stem cell transplantation.

The study was limited by small sample size and a short duration of follow-up, so durability of response can’t yet be assessed. Also, neither pharmacokinetics nor resistance mutations were tracked for participants.

Currently, the doublet regimen is designed to be continuous therapy, and although it’s not known whether this regimen would be effective as time-limited therapy, it’s unlikely because 100% of patients who had CR still had detectable minimal residual disease, the investigators noted.

Umbralisib and ibrutinib are also being explored as part of triplet therapy, with the type 2 CD20 antibody ublituximab, for relapsed or refractory B-cell malignancies (NCT02006485).

“These novel drug-based approaches, along with several others in development, hold promise as highly effective and well-tolerated regimens with the potential to substantially improve outcomes for patients with B-cell malignancies,” the investigators wrote.

The study was supported by TG Therapeutics and the Leukemia and Lymphoma Society Therapy Accelerator Program. The authors reported financial relationships with several pharmaceutical companies, including TG Therapeutics.

[email protected]

SOURCE: Davids MS et al. Lancet Haemtol. 2019;6:e38-47.

Dual B-cell receptor pathway blockade was tolerable and efficacious for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) who participated in a multicenter phase 1-1b clinical study that added umbralisib to ibrutinib.

The study “is the first successful combination for two drugs targeting the B-cell receptor pathway,” Matthew S. Davids, MD, of the Dana-Farber Cancer Institute in Boston and his colleagues wrote in the Lancet Haematology.

Of the 21 patients with CLL, 90% (n = 19) achieved an overall response (OR), 62% (n = 13) achieved partial response (PR) or PR with lymphocytosis, and 29% (n = 6) achieved complete response (CR). All patients in complete response still had minimal residual disease (MRD) in bone marrow. No CLL patients had progressive disease.

Of the 21 patients with MCL, 67% (n = 14) had an OR, with 19% (n = 4) showing CR and 48% (n = 10) achieving partial response. Three MCL patients (14%) had progressive disease.

Umbralisib is a next-generation phosphoinositide-3-kinase-delta inhibitor that, when added to the Bruton tyrosine kinase inhibitor (BTKi) ibrutinib, offers once-daily oral dosing. The combination affords the possibility of overcoming the resistance that can come with prolonged ibrutinib monotherapy.

A total of 44 patients were enrolled, and 42 patients (21 with CLL and 21 with MCL) received at least one dose of the study drug and were included in the analysis. At enrollment, patients had received a median of two previous therapies.

Diarrhea was the most frequent adverse event, seen in 22 patients (52%), and half of all patients (n = 21) had infections.

Hematologic toxicities included neutropenia, seen in 9 (43%) of the CLL patients and 8 (38%) of the MCL patients; thrombocytopenia, seen in 6 (29%) of the CLL patients and 10 (48%) of the MCL patients; and anemia, seen in 4 (19%) of the CLL and 9 (43%) of the MCL patients. Grade 3 and 4 hematologic toxicities of any type were less common, occurring in less than 20% of patients. One MCL patient developed febrile neutropenia. According to the study investigators, none of the hematologic toxicities were deemed related to the study drugs.

Adverse events did not appear to be dose-dependent for umbralisib, with the maximum tolerated dose not reached in the study, the investigators wrote. For phase 2 trials, the recommended dose of umbralisib is 800 mg given orally once daily in combination with ibrutinib.

“One unanticipated benefit of doublet B-cell receptor pathway inhibition in this study was the ability to continue one drug when a characteristic toxicity required the other drug to be held,” the investigators wrote.

For MCL patients, 67% achieved OR and 19% achieved CR, figures similar to those reported for ibrutinib monotherapy. However, “the 2-year progression-free survival of 49% and overall survival of 58% suggest that patients who made it to 1 year progression-free had few events during the second year on therapy,” the investigators wrote. They also noted that this MCL population was high risk; more than one-quarter of patients had relapsed after prior autologous stem cell transplantation.

The study was limited by small sample size and a short duration of follow-up, so durability of response can’t yet be assessed. Also, neither pharmacokinetics nor resistance mutations were tracked for participants.

Currently, the doublet regimen is designed to be continuous therapy, and although it’s not known whether this regimen would be effective as time-limited therapy, it’s unlikely because 100% of patients who had CR still had detectable minimal residual disease, the investigators noted.

Umbralisib and ibrutinib are also being explored as part of triplet therapy, with the type 2 CD20 antibody ublituximab, for relapsed or refractory B-cell malignancies (NCT02006485).

“These novel drug-based approaches, along with several others in development, hold promise as highly effective and well-tolerated regimens with the potential to substantially improve outcomes for patients with B-cell malignancies,” the investigators wrote.

The study was supported by TG Therapeutics and the Leukemia and Lymphoma Society Therapy Accelerator Program. The authors reported financial relationships with several pharmaceutical companies, including TG Therapeutics.

[email protected]

SOURCE: Davids MS et al. Lancet Haemtol. 2019;6:e38-47.

Dual B-cell receptor pathway blockade was tolerable and efficacious for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) who participated in a multicenter phase 1-1b clinical study that added umbralisib to ibrutinib.

The study “is the first successful combination for two drugs targeting the B-cell receptor pathway,” Matthew S. Davids, MD, of the Dana-Farber Cancer Institute in Boston and his colleagues wrote in the Lancet Haematology.

Of the 21 patients with CLL, 90% (n = 19) achieved an overall response (OR), 62% (n = 13) achieved partial response (PR) or PR with lymphocytosis, and 29% (n = 6) achieved complete response (CR). All patients in complete response still had minimal residual disease (MRD) in bone marrow. No CLL patients had progressive disease.

Of the 21 patients with MCL, 67% (n = 14) had an OR, with 19% (n = 4) showing CR and 48% (n = 10) achieving partial response. Three MCL patients (14%) had progressive disease.

Umbralisib is a next-generation phosphoinositide-3-kinase-delta inhibitor that, when added to the Bruton tyrosine kinase inhibitor (BTKi) ibrutinib, offers once-daily oral dosing. The combination affords the possibility of overcoming the resistance that can come with prolonged ibrutinib monotherapy.

A total of 44 patients were enrolled, and 42 patients (21 with CLL and 21 with MCL) received at least one dose of the study drug and were included in the analysis. At enrollment, patients had received a median of two previous therapies.

Diarrhea was the most frequent adverse event, seen in 22 patients (52%), and half of all patients (n = 21) had infections.

Hematologic toxicities included neutropenia, seen in 9 (43%) of the CLL patients and 8 (38%) of the MCL patients; thrombocytopenia, seen in 6 (29%) of the CLL patients and 10 (48%) of the MCL patients; and anemia, seen in 4 (19%) of the CLL and 9 (43%) of the MCL patients. Grade 3 and 4 hematologic toxicities of any type were less common, occurring in less than 20% of patients. One MCL patient developed febrile neutropenia. According to the study investigators, none of the hematologic toxicities were deemed related to the study drugs.

Adverse events did not appear to be dose-dependent for umbralisib, with the maximum tolerated dose not reached in the study, the investigators wrote. For phase 2 trials, the recommended dose of umbralisib is 800 mg given orally once daily in combination with ibrutinib.

“One unanticipated benefit of doublet B-cell receptor pathway inhibition in this study was the ability to continue one drug when a characteristic toxicity required the other drug to be held,” the investigators wrote.

For MCL patients, 67% achieved OR and 19% achieved CR, figures similar to those reported for ibrutinib monotherapy. However, “the 2-year progression-free survival of 49% and overall survival of 58% suggest that patients who made it to 1 year progression-free had few events during the second year on therapy,” the investigators wrote. They also noted that this MCL population was high risk; more than one-quarter of patients had relapsed after prior autologous stem cell transplantation.

The study was limited by small sample size and a short duration of follow-up, so durability of response can’t yet be assessed. Also, neither pharmacokinetics nor resistance mutations were tracked for participants.

Currently, the doublet regimen is designed to be continuous therapy, and although it’s not known whether this regimen would be effective as time-limited therapy, it’s unlikely because 100% of patients who had CR still had detectable minimal residual disease, the investigators noted.

Umbralisib and ibrutinib are also being explored as part of triplet therapy, with the type 2 CD20 antibody ublituximab, for relapsed or refractory B-cell malignancies (NCT02006485).

“These novel drug-based approaches, along with several others in development, hold promise as highly effective and well-tolerated regimens with the potential to substantially improve outcomes for patients with B-cell malignancies,” the investigators wrote.

The study was supported by TG Therapeutics and the Leukemia and Lymphoma Society Therapy Accelerator Program. The authors reported financial relationships with several pharmaceutical companies, including TG Therapeutics.

[email protected]

SOURCE: Davids MS et al. Lancet Haemtol. 2019;6:e38-47.

Isolated communities in the Canadian province of Newfoundland and Labrador have an “unusual prevalence” of certain hereditary bleeding disorders, a fact attributable to the province’s unique topography and settlement patterns, according to a new study.

Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

The prevalence of hemophilia A in Newfoundland and Labrador (NL) is 2.89 times higher than in the rest of Canada. Deficiencies in Factors V, XI, and XIII are 4.54, 5.44, and 9.22 times more prevalent in NL than mainland Canada, respectively. The study also found more cases than expected of the extremely rare hereditary bleeding disorder, Glanzmann thrombasthenia (n = 4). One case of Bernard-Soulier syndrome was also seen, the investigators reported in Transfusion and Apheresis Science.

“This comparatively high prevalence provides a potential pool of patients for genotype/phenotype research,” wrote Mary-Frances Scully, MD, a hematologist at Memorial University, St. John’s, Nfld., and her associates.

In addition to founding populations of indigenous Innu, Inuit, and Mi’kmaq populations, present-day residents of Canada’s easternmost province trace their lineages to about 28,000 settlers who came from southwest England and southeast Ireland for the area’s rich fisheries, explained Dr. Scully and her coauthors. The overall population density of NL is still very low, at about 1.38 individuals per square kilometer, less than half that of Canada overall and far less than the United States’ 36 per square kilometer.

Overall, the investigators reviewed records for 180 patients with hereditary bleeding disorders who were receiving specialty care in St. John’s. Most (n = 127) had hemophilia A; of these patients, those who had mutation testing primarily had the Val 2016A1 mutation. This was particularly true for patients with mild hemophilia A. More than 73% (83/111 patients) carried this mutation, demonstrating a founder effect, wrote Dr. Scully and her coauthors. The next most common hereditary bleeding disorder was Factor XI deficiency, seen in 29 patients.

Additionally, of the seven patients with Factor XIII deficiency, five were homozygous for the c.691-1 G greater than A mutation.

More males in NL than in global comparator data had Factor V deficiency and Glanzmann thrombasthenia, though Dr. Scully and her colleagues acknowledged that the numbers were low overall.

Coagulation tests performed at the time of diagnosis and before treatment initiation were used, when available, to ascertain the severity of the bleeding disorder. Patients were included whether they were heterozygous or homozygous for hereditary bleeding disorders, so long as their baseline coagulation factor levels were below predetermined cutoff levels.

Comparing the prevalence of all the hereditary bleeding disorders identified in the NL population against mainland Canada and that of four other reference countries – Iran, Ireland, the United Kingdom, and the United States – the increased prevalence rates in NL were highly statistically significant (P less than .0001) for all but the single case of Bernard-Soulier syndrome.

Hemophilia B was the only hereditary bleeding disorder seen less frequently in the NL population than in Canada or the other reference populations.

“These results show that NL’s unique geography and population distribution led to a genetic drift that increased the prevalence of some rare factor deficiencies,” wrote Dr. Scully and her colleagues.

The investigators plan to continue investigating and reporting genotype and phenotype correlations among their patient population; they also invite broader international collaboration into the prevalence of rare hereditary bleeding disorders in isolated populations.

The authors reported having no conflicts of interest and no outside sources of funding.
 

[email protected]

SOURCE: Scully M-F et al. Transfus Apher Sci. 2018 Dec;57(6):713-6.

Isolated communities in the Canadian province of Newfoundland and Labrador have an “unusual prevalence” of certain hereditary bleeding disorders, a fact attributable to the province’s unique topography and settlement patterns, according to a new study.

Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

The prevalence of hemophilia A in Newfoundland and Labrador (NL) is 2.89 times higher than in the rest of Canada. Deficiencies in Factors V, XI, and XIII are 4.54, 5.44, and 9.22 times more prevalent in NL than mainland Canada, respectively. The study also found more cases than expected of the extremely rare hereditary bleeding disorder, Glanzmann thrombasthenia (n = 4). One case of Bernard-Soulier syndrome was also seen, the investigators reported in Transfusion and Apheresis Science.

“This comparatively high prevalence provides a potential pool of patients for genotype/phenotype research,” wrote Mary-Frances Scully, MD, a hematologist at Memorial University, St. John’s, Nfld., and her associates.

In addition to founding populations of indigenous Innu, Inuit, and Mi’kmaq populations, present-day residents of Canada’s easternmost province trace their lineages to about 28,000 settlers who came from southwest England and southeast Ireland for the area’s rich fisheries, explained Dr. Scully and her coauthors. The overall population density of NL is still very low, at about 1.38 individuals per square kilometer, less than half that of Canada overall and far less than the United States’ 36 per square kilometer.

Overall, the investigators reviewed records for 180 patients with hereditary bleeding disorders who were receiving specialty care in St. John’s. Most (n = 127) had hemophilia A; of these patients, those who had mutation testing primarily had the Val 2016A1 mutation. This was particularly true for patients with mild hemophilia A. More than 73% (83/111 patients) carried this mutation, demonstrating a founder effect, wrote Dr. Scully and her coauthors. The next most common hereditary bleeding disorder was Factor XI deficiency, seen in 29 patients.

Additionally, of the seven patients with Factor XIII deficiency, five were homozygous for the c.691-1 G greater than A mutation.

More males in NL than in global comparator data had Factor V deficiency and Glanzmann thrombasthenia, though Dr. Scully and her colleagues acknowledged that the numbers were low overall.

Coagulation tests performed at the time of diagnosis and before treatment initiation were used, when available, to ascertain the severity of the bleeding disorder. Patients were included whether they were heterozygous or homozygous for hereditary bleeding disorders, so long as their baseline coagulation factor levels were below predetermined cutoff levels.

Comparing the prevalence of all the hereditary bleeding disorders identified in the NL population against mainland Canada and that of four other reference countries – Iran, Ireland, the United Kingdom, and the United States – the increased prevalence rates in NL were highly statistically significant (P less than .0001) for all but the single case of Bernard-Soulier syndrome.

Hemophilia B was the only hereditary bleeding disorder seen less frequently in the NL population than in Canada or the other reference populations.

“These results show that NL’s unique geography and population distribution led to a genetic drift that increased the prevalence of some rare factor deficiencies,” wrote Dr. Scully and her colleagues.

The investigators plan to continue investigating and reporting genotype and phenotype correlations among their patient population; they also invite broader international collaboration into the prevalence of rare hereditary bleeding disorders in isolated populations.

The authors reported having no conflicts of interest and no outside sources of funding.
 

[email protected]

SOURCE: Scully M-F et al. Transfus Apher Sci. 2018 Dec;57(6):713-6.

Isolated communities in the Canadian province of Newfoundland and Labrador have an “unusual prevalence” of certain hereditary bleeding disorders, a fact attributable to the province’s unique topography and settlement patterns, according to a new study.

Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

The prevalence of hemophilia A in Newfoundland and Labrador (NL) is 2.89 times higher than in the rest of Canada. Deficiencies in Factors V, XI, and XIII are 4.54, 5.44, and 9.22 times more prevalent in NL than mainland Canada, respectively. The study also found more cases than expected of the extremely rare hereditary bleeding disorder, Glanzmann thrombasthenia (n = 4). One case of Bernard-Soulier syndrome was also seen, the investigators reported in Transfusion and Apheresis Science.

“This comparatively high prevalence provides a potential pool of patients for genotype/phenotype research,” wrote Mary-Frances Scully, MD, a hematologist at Memorial University, St. John’s, Nfld., and her associates.

In addition to founding populations of indigenous Innu, Inuit, and Mi’kmaq populations, present-day residents of Canada’s easternmost province trace their lineages to about 28,000 settlers who came from southwest England and southeast Ireland for the area’s rich fisheries, explained Dr. Scully and her coauthors. The overall population density of NL is still very low, at about 1.38 individuals per square kilometer, less than half that of Canada overall and far less than the United States’ 36 per square kilometer.

Overall, the investigators reviewed records for 180 patients with hereditary bleeding disorders who were receiving specialty care in St. John’s. Most (n = 127) had hemophilia A; of these patients, those who had mutation testing primarily had the Val 2016A1 mutation. This was particularly true for patients with mild hemophilia A. More than 73% (83/111 patients) carried this mutation, demonstrating a founder effect, wrote Dr. Scully and her coauthors. The next most common hereditary bleeding disorder was Factor XI deficiency, seen in 29 patients.

Additionally, of the seven patients with Factor XIII deficiency, five were homozygous for the c.691-1 G greater than A mutation.

More males in NL than in global comparator data had Factor V deficiency and Glanzmann thrombasthenia, though Dr. Scully and her colleagues acknowledged that the numbers were low overall.

Coagulation tests performed at the time of diagnosis and before treatment initiation were used, when available, to ascertain the severity of the bleeding disorder. Patients were included whether they were heterozygous or homozygous for hereditary bleeding disorders, so long as their baseline coagulation factor levels were below predetermined cutoff levels.

Comparing the prevalence of all the hereditary bleeding disorders identified in the NL population against mainland Canada and that of four other reference countries – Iran, Ireland, the United Kingdom, and the United States – the increased prevalence rates in NL were highly statistically significant (P less than .0001) for all but the single case of Bernard-Soulier syndrome.

Hemophilia B was the only hereditary bleeding disorder seen less frequently in the NL population than in Canada or the other reference populations.

“These results show that NL’s unique geography and population distribution led to a genetic drift that increased the prevalence of some rare factor deficiencies,” wrote Dr. Scully and her colleagues.

The investigators plan to continue investigating and reporting genotype and phenotype correlations among their patient population; they also invite broader international collaboration into the prevalence of rare hereditary bleeding disorders in isolated populations.

The authors reported having no conflicts of interest and no outside sources of funding.
 

[email protected]

SOURCE: Scully M-F et al. Transfus Apher Sci. 2018 Dec;57(6):713-6.

Children in military families face unique challenges and stressors related to deployment and frequent relocation. However, these children also have access to an array of services of which civilian pediatricians and other care providers may be unaware.

Senior Airman Kaylee Clark/U.S. Air Force

New guidance from the American Academy of Pediatrics’ Section on Uniformed Services details needs, challenges, and opportunities for military-connected children and points clinicians to resources for these families.

For clinicians who care for military-connected children, key suggestions outlined in the report include attainment of cultural competency; this begins with simply asking about the military status of families, wrote Cmdr. Chadley R. Huebner, MD, MPH, the lead author of the report published in Pediatrics.

A Veteran’s Affairs Community Provider Toolkit gives good grounding in military culture, he added.

The behavioral and emotional screening recommended by the AAP as part of routine pediatric practice also will provide clinicians with valuable information to help guide care of military-connected children; asking about prior or current parental military service and deployment also will help guide care.

Up to half of children in military families receive care in civilian settings, according to Dr. Huebner. “Many children in military families live in settings remote from a military community, and civilian health providers are faced with caring for military children in their practices.”

Dr. Huebner, an active duty commander in the U.S. Navy, led the revision of a 2013 report on the health and mental health needs of children in U.S. military families.

The broad category of military-connected children includes not just the estimated 1.3 million children of active duty service members, but also children of 818,000 National Guard and Reserve members and more than 2 million military retirees. All told, about 4 million children are in military-connected families, with about a third of these aged 5 years or younger.

In an era where the United States has been involved in multiple conflicts, deployment is the best-known stressor for military families. “The stressors associated with deployment, including prolonged family separation, potential injury or death of a service member, and traumatic experiences, can have a cumulative negative effect on the entire family unit,” wrote Dr. Huebner.

Even in young children aged 8 years and under, mental and behavioral health visits increase during deployment; older children experience more psychosocial morbidity as parental stress increases, an effect that can be mitigated by military support systems. Much existing research focuses on “the immediate effects of wartime deployment, and more longitudinal studies are needed to assess the long-term effects,” he wrote.

Still, neglect and child maltreatment increase in military families that have experienced deployment, with the risk increasing at the time of redeployment.

In addition to the known family stresses of deployment, children in military families face frequent relocation, with transitions occurring every 2-4 years and an average of nine schools attended by high school graduation, according to government data cited by Dr. Huebner.

Relocation within the past year is associated with increased use of mental health services, and adolescents in this group saw more psychiatric hospitalizations and ED visits. However, increased resilience among children in military families has been seen in some studies, with frequent relocation associated with fewer problems in school and a positive attitude about the changes associated with moves.

And families turn to each other for support with frequent moves. “Because families often move away from extended family support, they often refer to the military community as a surrogate family that provides a support network,” wrote Dr. Huebner.

Reservists don’t relocate as frequently as active duty service members but are more likely to live in areas without military resources, and their children’s peers, teachers, and caregivers may not be aware of the special challenges of military life. Similar isolation may occur when veterans make the transition to civilian life, with changes in eligibility for and access to military services and benefits.

Military programs can help

Military families, their children, and care providers and educators can turn to the military for help in many areas, whether families are receiving mental and physical health care through the military or from civilian facilities.

A key resource for neglect and abuse prevention is the military’s Family Advocacy Program (FAP), which engages families by means of workshops and other support programs. When child maltreatment is alleged, FAP also conducts its own investigation, so health care professionals should include the local FAP office in the reporting process when there are concerns.

For new parents, home visits and other support programs are available through the New Parent Support program, which will connect families to resources within the community and the Department of Defense (DOD).

Families living near or on military facilities may access DOD-sponsored infant and preschool child development programs, as well as school-aged care programs; subsidies for civilian childcare are also available. Although these programs constitute the country’s largest employer-sponsored childcare program, they serve just a small minority of military families, noted Dr. Huebner, citing a 2008 study by RAND.

DOD schools are attended by 72,000 students, but DOD resources stretch into civilian schools: School liaison offices assist civilian schools and military families located near military installations, and grant funding helps the DOD partner with civilian schools serving military-connected children.

Turning to health care, the military health system provides care globally to service members, retirees, and their families. Tricare is a single-payer, government-managed insurance program that is managed through regional contracts; some care is also delivered through the centralized Military Health System.

Whether Tricare participants receive care at military facilities or from civilian network providers, they generally do not have out-of-pocket costs unless they enroll in the Tricare Select program, a fee-for-service plan that involved cost sharing with deductibles. A link to information about how to connect patients to a Tricare provider or how to become on is available in the full report in Pediatrics.

About 20% of military-connected children have special health care needs and may receive specialty care through civilian providers. To help these families navigate multiple systems of care, the DOD provides a publication called Special Needs Tool Kit: Birth to 18. This toolkit guides families through early intervention and special education, and also provides military-specific information about relocation, Tricare benefits, and military support services.

A program available to all family members with special education or chronic medical needs is the Exceptional Family Members Program (EFMP). Children with autism spectrum disorders and ADHD, for example, are eligible for EFMP enrollment.

Additional supplemental benefits, with rank-adjusted sliding fees, are available for children with serious developmental and physical problems; children with autism spectrum disorders are eligible for additional therapy through an autism care demonstration program.

Forms to document chronic medical conditions (DD Form 2792) and special educational needs, if needed (DD Form 2791-1), are required for EFMP enrollment, which is mandatory for children of active duty personnel. Guidance for completing the forms can be found at www.militaryonesource.mil.

When overseas posts are imminent, clinicians should know that certain medical conditions may disqualify children from accompanying their service member parent. Overseas screening coordinators within the military medical system serve as the point of contact for the family and pediatrician in such circumstances, and clinicians can help families by providing appropriate documentation early in the process.

In addition to attaining military cultural competence, being aware of resources available to military families, and working closely with school personnel to support military-connected children, local and national advocacy efforts can make a difference, noted Dr. Huebner. And in all cases, “health care professional, schools, and communities should proactively reach out to military families.”

Dr. Huebner reported no conflicts of interest and no outside sources of funding. The full report contains hyperlinks to all resources named.

SOURCE: Huebner CR. Pediatrics. 2019;143(1):e20183258.

Children in military families face unique challenges and stressors related to deployment and frequent relocation. However, these children also have access to an array of services of which civilian pediatricians and other care providers may be unaware.

Senior Airman Kaylee Clark/U.S. Air Force

New guidance from the American Academy of Pediatrics’ Section on Uniformed Services details needs, challenges, and opportunities for military-connected children and points clinicians to resources for these families.

For clinicians who care for military-connected children, key suggestions outlined in the report include attainment of cultural competency; this begins with simply asking about the military status of families, wrote Cmdr. Chadley R. Huebner, MD, MPH, the lead author of the report published in Pediatrics.

A Veteran’s Affairs Community Provider Toolkit gives good grounding in military culture, he added.

The behavioral and emotional screening recommended by the AAP as part of routine pediatric practice also will provide clinicians with valuable information to help guide care of military-connected children; asking about prior or current parental military service and deployment also will help guide care.

Up to half of children in military families receive care in civilian settings, according to Dr. Huebner. “Many children in military families live in settings remote from a military community, and civilian health providers are faced with caring for military children in their practices.”

Dr. Huebner, an active duty commander in the U.S. Navy, led the revision of a 2013 report on the health and mental health needs of children in U.S. military families.

The broad category of military-connected children includes not just the estimated 1.3 million children of active duty service members, but also children of 818,000 National Guard and Reserve members and more than 2 million military retirees. All told, about 4 million children are in military-connected families, with about a third of these aged 5 years or younger.

In an era where the United States has been involved in multiple conflicts, deployment is the best-known stressor for military families. “The stressors associated with deployment, including prolonged family separation, potential injury or death of a service member, and traumatic experiences, can have a cumulative negative effect on the entire family unit,” wrote Dr. Huebner.

Even in young children aged 8 years and under, mental and behavioral health visits increase during deployment; older children experience more psychosocial morbidity as parental stress increases, an effect that can be mitigated by military support systems. Much existing research focuses on “the immediate effects of wartime deployment, and more longitudinal studies are needed to assess the long-term effects,” he wrote.

Still, neglect and child maltreatment increase in military families that have experienced deployment, with the risk increasing at the time of redeployment.

In addition to the known family stresses of deployment, children in military families face frequent relocation, with transitions occurring every 2-4 years and an average of nine schools attended by high school graduation, according to government data cited by Dr. Huebner.

Relocation within the past year is associated with increased use of mental health services, and adolescents in this group saw more psychiatric hospitalizations and ED visits. However, increased resilience among children in military families has been seen in some studies, with frequent relocation associated with fewer problems in school and a positive attitude about the changes associated with moves.

And families turn to each other for support with frequent moves. “Because families often move away from extended family support, they often refer to the military community as a surrogate family that provides a support network,” wrote Dr. Huebner.

Reservists don’t relocate as frequently as active duty service members but are more likely to live in areas without military resources, and their children’s peers, teachers, and caregivers may not be aware of the special challenges of military life. Similar isolation may occur when veterans make the transition to civilian life, with changes in eligibility for and access to military services and benefits.

Military programs can help

Military families, their children, and care providers and educators can turn to the military for help in many areas, whether families are receiving mental and physical health care through the military or from civilian facilities.

A key resource for neglect and abuse prevention is the military’s Family Advocacy Program (FAP), which engages families by means of workshops and other support programs. When child maltreatment is alleged, FAP also conducts its own investigation, so health care professionals should include the local FAP office in the reporting process when there are concerns.

For new parents, home visits and other support programs are available through the New Parent Support program, which will connect families to resources within the community and the Department of Defense (DOD).

Families living near or on military facilities may access DOD-sponsored infant and preschool child development programs, as well as school-aged care programs; subsidies for civilian childcare are also available. Although these programs constitute the country’s largest employer-sponsored childcare program, they serve just a small minority of military families, noted Dr. Huebner, citing a 2008 study by RAND.

DOD schools are attended by 72,000 students, but DOD resources stretch into civilian schools: School liaison offices assist civilian schools and military families located near military installations, and grant funding helps the DOD partner with civilian schools serving military-connected children.

Turning to health care, the military health system provides care globally to service members, retirees, and their families. Tricare is a single-payer, government-managed insurance program that is managed through regional contracts; some care is also delivered through the centralized Military Health System.

Whether Tricare participants receive care at military facilities or from civilian network providers, they generally do not have out-of-pocket costs unless they enroll in the Tricare Select program, a fee-for-service plan that involved cost sharing with deductibles. A link to information about how to connect patients to a Tricare provider or how to become on is available in the full report in Pediatrics.

About 20% of military-connected children have special health care needs and may receive specialty care through civilian providers. To help these families navigate multiple systems of care, the DOD provides a publication called Special Needs Tool Kit: Birth to 18. This toolkit guides families through early intervention and special education, and also provides military-specific information about relocation, Tricare benefits, and military support services.

A program available to all family members with special education or chronic medical needs is the Exceptional Family Members Program (EFMP). Children with autism spectrum disorders and ADHD, for example, are eligible for EFMP enrollment.

Additional supplemental benefits, with rank-adjusted sliding fees, are available for children with serious developmental and physical problems; children with autism spectrum disorders are eligible for additional therapy through an autism care demonstration program.

Forms to document chronic medical conditions (DD Form 2792) and special educational needs, if needed (DD Form 2791-1), are required for EFMP enrollment, which is mandatory for children of active duty personnel. Guidance for completing the forms can be found at www.militaryonesource.mil.

When overseas posts are imminent, clinicians should know that certain medical conditions may disqualify children from accompanying their service member parent. Overseas screening coordinators within the military medical system serve as the point of contact for the family and pediatrician in such circumstances, and clinicians can help families by providing appropriate documentation early in the process.

In addition to attaining military cultural competence, being aware of resources available to military families, and working closely with school personnel to support military-connected children, local and national advocacy efforts can make a difference, noted Dr. Huebner. And in all cases, “health care professional, schools, and communities should proactively reach out to military families.”

Dr. Huebner reported no conflicts of interest and no outside sources of funding. The full report contains hyperlinks to all resources named.

SOURCE: Huebner CR. Pediatrics. 2019;143(1):e20183258.

Children in military families face unique challenges and stressors related to deployment and frequent relocation. However, these children also have access to an array of services of which civilian pediatricians and other care providers may be unaware.

Senior Airman Kaylee Clark/U.S. Air Force

New guidance from the American Academy of Pediatrics’ Section on Uniformed Services details needs, challenges, and opportunities for military-connected children and points clinicians to resources for these families.

For clinicians who care for military-connected children, key suggestions outlined in the report include attainment of cultural competency; this begins with simply asking about the military status of families, wrote Cmdr. Chadley R. Huebner, MD, MPH, the lead author of the report published in Pediatrics.

A Veteran’s Affairs Community Provider Toolkit gives good grounding in military culture, he added.

The behavioral and emotional screening recommended by the AAP as part of routine pediatric practice also will provide clinicians with valuable information to help guide care of military-connected children; asking about prior or current parental military service and deployment also will help guide care.

Up to half of children in military families receive care in civilian settings, according to Dr. Huebner. “Many children in military families live in settings remote from a military community, and civilian health providers are faced with caring for military children in their practices.”

Dr. Huebner, an active duty commander in the U.S. Navy, led the revision of a 2013 report on the health and mental health needs of children in U.S. military families.

The broad category of military-connected children includes not just the estimated 1.3 million children of active duty service members, but also children of 818,000 National Guard and Reserve members and more than 2 million military retirees. All told, about 4 million children are in military-connected families, with about a third of these aged 5 years or younger.

In an era where the United States has been involved in multiple conflicts, deployment is the best-known stressor for military families. “The stressors associated with deployment, including prolonged family separation, potential injury or death of a service member, and traumatic experiences, can have a cumulative negative effect on the entire family unit,” wrote Dr. Huebner.

Even in young children aged 8 years and under, mental and behavioral health visits increase during deployment; older children experience more psychosocial morbidity as parental stress increases, an effect that can be mitigated by military support systems. Much existing research focuses on “the immediate effects of wartime deployment, and more longitudinal studies are needed to assess the long-term effects,” he wrote.

Still, neglect and child maltreatment increase in military families that have experienced deployment, with the risk increasing at the time of redeployment.

In addition to the known family stresses of deployment, children in military families face frequent relocation, with transitions occurring every 2-4 years and an average of nine schools attended by high school graduation, according to government data cited by Dr. Huebner.

Relocation within the past year is associated with increased use of mental health services, and adolescents in this group saw more psychiatric hospitalizations and ED visits. However, increased resilience among children in military families has been seen in some studies, with frequent relocation associated with fewer problems in school and a positive attitude about the changes associated with moves.

And families turn to each other for support with frequent moves. “Because families often move away from extended family support, they often refer to the military community as a surrogate family that provides a support network,” wrote Dr. Huebner.

Reservists don’t relocate as frequently as active duty service members but are more likely to live in areas without military resources, and their children’s peers, teachers, and caregivers may not be aware of the special challenges of military life. Similar isolation may occur when veterans make the transition to civilian life, with changes in eligibility for and access to military services and benefits.

Military programs can help

Military families, their children, and care providers and educators can turn to the military for help in many areas, whether families are receiving mental and physical health care through the military or from civilian facilities.

A key resource for neglect and abuse prevention is the military’s Family Advocacy Program (FAP), which engages families by means of workshops and other support programs. When child maltreatment is alleged, FAP also conducts its own investigation, so health care professionals should include the local FAP office in the reporting process when there are concerns.

For new parents, home visits and other support programs are available through the New Parent Support program, which will connect families to resources within the community and the Department of Defense (DOD).

Families living near or on military facilities may access DOD-sponsored infant and preschool child development programs, as well as school-aged care programs; subsidies for civilian childcare are also available. Although these programs constitute the country’s largest employer-sponsored childcare program, they serve just a small minority of military families, noted Dr. Huebner, citing a 2008 study by RAND.

DOD schools are attended by 72,000 students, but DOD resources stretch into civilian schools: School liaison offices assist civilian schools and military families located near military installations, and grant funding helps the DOD partner with civilian schools serving military-connected children.

Turning to health care, the military health system provides care globally to service members, retirees, and their families. Tricare is a single-payer, government-managed insurance program that is managed through regional contracts; some care is also delivered through the centralized Military Health System.

Whether Tricare participants receive care at military facilities or from civilian network providers, they generally do not have out-of-pocket costs unless they enroll in the Tricare Select program, a fee-for-service plan that involved cost sharing with deductibles. A link to information about how to connect patients to a Tricare provider or how to become on is available in the full report in Pediatrics.

About 20% of military-connected children have special health care needs and may receive specialty care through civilian providers. To help these families navigate multiple systems of care, the DOD provides a publication called Special Needs Tool Kit: Birth to 18. This toolkit guides families through early intervention and special education, and also provides military-specific information about relocation, Tricare benefits, and military support services.

A program available to all family members with special education or chronic medical needs is the Exceptional Family Members Program (EFMP). Children with autism spectrum disorders and ADHD, for example, are eligible for EFMP enrollment.

Additional supplemental benefits, with rank-adjusted sliding fees, are available for children with serious developmental and physical problems; children with autism spectrum disorders are eligible for additional therapy through an autism care demonstration program.

Forms to document chronic medical conditions (DD Form 2792) and special educational needs, if needed (DD Form 2791-1), are required for EFMP enrollment, which is mandatory for children of active duty personnel. Guidance for completing the forms can be found at www.militaryonesource.mil.

When overseas posts are imminent, clinicians should know that certain medical conditions may disqualify children from accompanying their service member parent. Overseas screening coordinators within the military medical system serve as the point of contact for the family and pediatrician in such circumstances, and clinicians can help families by providing appropriate documentation early in the process.

In addition to attaining military cultural competence, being aware of resources available to military families, and working closely with school personnel to support military-connected children, local and national advocacy efforts can make a difference, noted Dr. Huebner. And in all cases, “health care professional, schools, and communities should proactively reach out to military families.”

Dr. Huebner reported no conflicts of interest and no outside sources of funding. The full report contains hyperlinks to all resources named.

SOURCE: Huebner CR. Pediatrics. 2019;143(1):e20183258.

Black women were more likely than white women to undergo open hysterectomy, according to a recent analysis of national surgical data by Amy L. Alexander, MD, MS, of Northwestern University, Chicago, and her colleagues.

Thomas Northcut/Getty Images

Even after the researchers controlled for many factors that might influence surgical approach, such as comorbidities and body mass index, black women had an odds ratio of 2.02 to receive open, rather than laparoscopic, hysterectomy (95% confidence interval, 1.85-2.20), according to a study in Obstetrics & Gynecology.

The analysis of the targeted hysterectomy file in the National Surgical Quality Improvement Program (NSQIP) database showed that, of 15,316 women who had hysterectomy for nonmalignant indications, the 25% who were black also were more likely to have major complications with open procedures. Such complications as sepsis, wound dehiscence, prolonged intubation, and death were seen in 4% of the black women, versus 2% of the white women receiving open hysterectomy (P less than .001). Minor complications, such as urinary tract infections, superficial wound infections, and blood transfusions, also were more common for black women having open procedures (11% vs. 7%; P less than .001).

The study used a large national database with detailed information about comorbidities and patient characteristics to look at racial disparities in surgical route and complications for the second-most-common surgical procedure women receive on the United States. The results, said Dr. Alexander and her coauthors, confirm and extend previous work showing these disparities.

Black women are known to have more diabetes and hypertension, as well as higher rates of obesity, compared with white women, wrote Dr. Alexander and her coauthors. Even after they controlled for all these variables, black women still had significantly higher odds of having complications from hysterectomy: The odds ratios for major and minor complications were 1.56 and 1.27, respectively.

Uterine weight was included and tracked as a binary variable, with large uteri considered those weighing 250 g or more. Making uterine weight a binary, rather than continuous or categorical variable, didn’t significantly change results, and realistically mirrors a surgeon’s assessment of a uterus as “large” or “small” when making treatment decisions, Dr. Alexander and her coauthors said.

Because the median weight of uteri from black women was more than double the weight of those from white women (262 g vs. 123 g), the investigators also performed an analysis looking just at women with uterine weight less than 250 g, to ensure that uterine weight alone was not accounting for much of the disparity. In this analysis, the black patients still had an adjusted odds ratio of 1.84 for receiving an open procedure.

“Some of the postoperative complications experienced by black women are likely attributable to the fact that black women are more likely to undergo an open hysterectomy,” noted Dr. Alexander and her colleagues. “However, because black race is still associated with a higher odds of complications, even when adjusting for hysterectomy route, there are other contributing factors that warrant further investigation.” Among these factors, they said, may be access to care and quality of care while hospitalized.

The study’s strengths include the use of the NSQIP database’s prospectively collected data to construct the cohort study; the data base included “important patient-level factors such as uterine size, obesity, and comorbidities not previously available in other secondary data set studies,” noted Dr. Alexander and her colleagues. But the possibility of unmeasured bias persists, they said, and such variables as regional practice patterns and surgeon experience and procedure volume could not be detected from the NSQIP data on hand.

“This study suggests that an important step to reduce the disparity in route of surgery and postoperative complications is to increase access to and use of minimally invasive surgery,” wrote Dr. Alexander and her coauthors.

The study was funded by the National Institutes of Health. Dr. Alexander and her colleagues reported no conflicts of interest.

[email protected]

SOURCE: Alexander AL et al. Obstet Gynecol. 2018 Dec 4. doi: 10.1097/AOG.0000000000002990

Black women were more likely than white women to undergo open hysterectomy, according to a recent analysis of national surgical data by Amy L. Alexander, MD, MS, of Northwestern University, Chicago, and her colleagues.

Thomas Northcut/Getty Images

Even after the researchers controlled for many factors that might influence surgical approach, such as comorbidities and body mass index, black women had an odds ratio of 2.02 to receive open, rather than laparoscopic, hysterectomy (95% confidence interval, 1.85-2.20), according to a study in Obstetrics & Gynecology.

The analysis of the targeted hysterectomy file in the National Surgical Quality Improvement Program (NSQIP) database showed that, of 15,316 women who had hysterectomy for nonmalignant indications, the 25% who were black also were more likely to have major complications with open procedures. Such complications as sepsis, wound dehiscence, prolonged intubation, and death were seen in 4% of the black women, versus 2% of the white women receiving open hysterectomy (P less than .001). Minor complications, such as urinary tract infections, superficial wound infections, and blood transfusions, also were more common for black women having open procedures (11% vs. 7%; P less than .001).

The study used a large national database with detailed information about comorbidities and patient characteristics to look at racial disparities in surgical route and complications for the second-most-common surgical procedure women receive on the United States. The results, said Dr. Alexander and her coauthors, confirm and extend previous work showing these disparities.

Black women are known to have more diabetes and hypertension, as well as higher rates of obesity, compared with white women, wrote Dr. Alexander and her coauthors. Even after they controlled for all these variables, black women still had significantly higher odds of having complications from hysterectomy: The odds ratios for major and minor complications were 1.56 and 1.27, respectively.

Uterine weight was included and tracked as a binary variable, with large uteri considered those weighing 250 g or more. Making uterine weight a binary, rather than continuous or categorical variable, didn’t significantly change results, and realistically mirrors a surgeon’s assessment of a uterus as “large” or “small” when making treatment decisions, Dr. Alexander and her coauthors said.

Because the median weight of uteri from black women was more than double the weight of those from white women (262 g vs. 123 g), the investigators also performed an analysis looking just at women with uterine weight less than 250 g, to ensure that uterine weight alone was not accounting for much of the disparity. In this analysis, the black patients still had an adjusted odds ratio of 1.84 for receiving an open procedure.

“Some of the postoperative complications experienced by black women are likely attributable to the fact that black women are more likely to undergo an open hysterectomy,” noted Dr. Alexander and her colleagues. “However, because black race is still associated with a higher odds of complications, even when adjusting for hysterectomy route, there are other contributing factors that warrant further investigation.” Among these factors, they said, may be access to care and quality of care while hospitalized.

The study’s strengths include the use of the NSQIP database’s prospectively collected data to construct the cohort study; the data base included “important patient-level factors such as uterine size, obesity, and comorbidities not previously available in other secondary data set studies,” noted Dr. Alexander and her colleagues. But the possibility of unmeasured bias persists, they said, and such variables as regional practice patterns and surgeon experience and procedure volume could not be detected from the NSQIP data on hand.

“This study suggests that an important step to reduce the disparity in route of surgery and postoperative complications is to increase access to and use of minimally invasive surgery,” wrote Dr. Alexander and her coauthors.

The study was funded by the National Institutes of Health. Dr. Alexander and her colleagues reported no conflicts of interest.

[email protected]

SOURCE: Alexander AL et al. Obstet Gynecol. 2018 Dec 4. doi: 10.1097/AOG.0000000000002990

Black women were more likely than white women to undergo open hysterectomy, according to a recent analysis of national surgical data by Amy L. Alexander, MD, MS, of Northwestern University, Chicago, and her colleagues.

Thomas Northcut/Getty Images

Even after the researchers controlled for many factors that might influence surgical approach, such as comorbidities and body mass index, black women had an odds ratio of 2.02 to receive open, rather than laparoscopic, hysterectomy (95% confidence interval, 1.85-2.20), according to a study in Obstetrics & Gynecology.

The analysis of the targeted hysterectomy file in the National Surgical Quality Improvement Program (NSQIP) database showed that, of 15,316 women who had hysterectomy for nonmalignant indications, the 25% who were black also were more likely to have major complications with open procedures. Such complications as sepsis, wound dehiscence, prolonged intubation, and death were seen in 4% of the black women, versus 2% of the white women receiving open hysterectomy (P less than .001). Minor complications, such as urinary tract infections, superficial wound infections, and blood transfusions, also were more common for black women having open procedures (11% vs. 7%; P less than .001).

The study used a large national database with detailed information about comorbidities and patient characteristics to look at racial disparities in surgical route and complications for the second-most-common surgical procedure women receive on the United States. The results, said Dr. Alexander and her coauthors, confirm and extend previous work showing these disparities.

Black women are known to have more diabetes and hypertension, as well as higher rates of obesity, compared with white women, wrote Dr. Alexander and her coauthors. Even after they controlled for all these variables, black women still had significantly higher odds of having complications from hysterectomy: The odds ratios for major and minor complications were 1.56 and 1.27, respectively.

Uterine weight was included and tracked as a binary variable, with large uteri considered those weighing 250 g or more. Making uterine weight a binary, rather than continuous or categorical variable, didn’t significantly change results, and realistically mirrors a surgeon’s assessment of a uterus as “large” or “small” when making treatment decisions, Dr. Alexander and her coauthors said.

Because the median weight of uteri from black women was more than double the weight of those from white women (262 g vs. 123 g), the investigators also performed an analysis looking just at women with uterine weight less than 250 g, to ensure that uterine weight alone was not accounting for much of the disparity. In this analysis, the black patients still had an adjusted odds ratio of 1.84 for receiving an open procedure.

“Some of the postoperative complications experienced by black women are likely attributable to the fact that black women are more likely to undergo an open hysterectomy,” noted Dr. Alexander and her colleagues. “However, because black race is still associated with a higher odds of complications, even when adjusting for hysterectomy route, there are other contributing factors that warrant further investigation.” Among these factors, they said, may be access to care and quality of care while hospitalized.

The study’s strengths include the use of the NSQIP database’s prospectively collected data to construct the cohort study; the data base included “important patient-level factors such as uterine size, obesity, and comorbidities not previously available in other secondary data set studies,” noted Dr. Alexander and her colleagues. But the possibility of unmeasured bias persists, they said, and such variables as regional practice patterns and surgeon experience and procedure volume could not be detected from the NSQIP data on hand.

“This study suggests that an important step to reduce the disparity in route of surgery and postoperative complications is to increase access to and use of minimally invasive surgery,” wrote Dr. Alexander and her coauthors.

The study was funded by the National Institutes of Health. Dr. Alexander and her colleagues reported no conflicts of interest.

[email protected]

SOURCE: Alexander AL et al. Obstet Gynecol. 2018 Dec 4. doi: 10.1097/AOG.0000000000002990

NASHVILLE, TENN. – Patients who took a fixed-dose combination of phentermine and topiramate–extended release (ER) lost over 15% of their body weight at 12 months, according to real-world experience from the Mayo Clinic in Rochester, Minn.

Kari Oakes/MDedge News

The results seen with the medication combo – a mean 15.5% total body weight loss at 12 months – bested the 8%-11% seen in randomized controlled trials (RCTs), said Gerardo Calderon, MD, in an interview during a poster session at Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery. The combination was also the most commonly prescribed weight loss medication at the Mayo Clinic, where Dr. Calderon is a gastroenterology and hepatology research fellow.

Patients taking lorcaserin at the Mayo Clinic also lost more weight loss than RCT participants (8.8% vs. 5%-6%, respectively). Notably, they also had a higher probability of losing at least 10% of their baseline total body weight (40% vs. 17%-23% in clinical trials). In RCTs, 37%-48% of patients taking phentermine/topiramate-ER had a total body weight loss of at least 10%, similar to the Mayo Clinic’s figure of 49%.

The rate of reported adverse events – 23.8% – exceeded that reported in RCTs, noted Dr. Calderon. Gastrointestinal symptoms, such as nausea, vomiting, diarrhea, and constipation, were reported by 2%-20% of patients across the various drugs prescribed. Insomnia and mood changes, along with dizziness or lightheadedness, were reported by 2%-6% of patients. Almost 12% of patients taking phentermine/topiramate-SR reported paresthesias. No patients stopped taking their medication because of side effects, however.

The study was a review of patients seen at the Mayo Clinic during January 2016 – June 2018. Patients were included if they were prescribed weight loss medications and had a body mass index of at least 25 kg/m² with comorbidities related to adiposity or with a BMI of at least 30 without such comorbidities. To be included, patients had to be followed for at least 3 months and see a Mayo Clinic physician at least twice.

Patients with previous bariatric surgery or other major gastrointestinal surgery, those who didn’t use their medications because of insurance problems or drug costs, and those who were on weight loss medication before being seen for the first time were excluded from the study.

Patients were a mean 49 years old, and most were female (86/118; 72.9%). Mean BMI at enrollment was 41.7, with a mean weight of 117.6 kg.

Of 118 patients, 76 (64.4%) had dyslipidemia. About half of patients reported obstructive sleep apnea, and the same amount had hypertension. About 40% had diabetes, and the same number had degenerative joint disease.

Phentermine/topiramate was prescribed the most frequently, with 43.2% of patients on this medication. Liraglutide was taken by 34.7% of patients, bupropion/naltrexone-SR by 16.1%, and lorcaserin by 5.9%.

Patients taking liraglutide had similar weight loss (7.1%) to that seen in RCTs (6%-8%). For this medication, the real-world Mayo Clinic experience showed less chance of hitting the 10% total body weight loss mark (12% vs. 26%-33% in RCTs).

For bupropion/naltrexone-SR, weight loss was similar among the Mayo Clinic patients (7.2%) and RCT participants (5%-8%), and probability of achieving at least 10% total body weight loss was similar as well (32% vs. 34%).

Weight loss medication was a component of a multidisciplinary weight loss approach at Mayo Clinic. Physicians, dietitians, and psychologists worked together to care for patients with overweight and obesity at his facility, Dr. Calderon said. Overall, patients were followed for a mean 6.7 months, and patients had a mean 3 follow-up visits, with over half of patients attending at least one follow-up appointment in study months 6-12. At 12 months, though, the attrition rate was 57.9%. “We notice an attrition rate of almost 60% at 1 year. People are not coming to their follow-up. ... Definitely, this is something we are concerned about, and we would like to bring these attrition rates lower,” he said.

Most patients (63.6%) saw a dietitian, but on average, patients had just one appointment. “At the Mayo Clinic, we provide dietitians and psychological support. But it’s up to the patients if they want to have it or not,” said Dr. Calderon. “Most of them, they just went once to a dietitian.”

“Overall, these outcomes are similar to those in RCTs and support the concept that weight loss medications can achieve clinically significant weight loss in a multidisciplinary weight loss program,” noted Dr. Calderon and his coauthors.

Dr. Calderon reported no outside sources of funding and no conflicts of interest.

[email protected]

SOURCE: Calderon G et al. Obesity Week, Abstract T-P-3425.

NASHVILLE, TENN. – Patients who took a fixed-dose combination of phentermine and topiramate–extended release (ER) lost over 15% of their body weight at 12 months, according to real-world experience from the Mayo Clinic in Rochester, Minn.

Kari Oakes/MDedge News

The results seen with the medication combo – a mean 15.5% total body weight loss at 12 months – bested the 8%-11% seen in randomized controlled trials (RCTs), said Gerardo Calderon, MD, in an interview during a poster session at Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery. The combination was also the most commonly prescribed weight loss medication at the Mayo Clinic, where Dr. Calderon is a gastroenterology and hepatology research fellow.

Patients taking lorcaserin at the Mayo Clinic also lost more weight loss than RCT participants (8.8% vs. 5%-6%, respectively). Notably, they also had a higher probability of losing at least 10% of their baseline total body weight (40% vs. 17%-23% in clinical trials). In RCTs, 37%-48% of patients taking phentermine/topiramate-ER had a total body weight loss of at least 10%, similar to the Mayo Clinic’s figure of 49%.

The rate of reported adverse events – 23.8% – exceeded that reported in RCTs, noted Dr. Calderon. Gastrointestinal symptoms, such as nausea, vomiting, diarrhea, and constipation, were reported by 2%-20% of patients across the various drugs prescribed. Insomnia and mood changes, along with dizziness or lightheadedness, were reported by 2%-6% of patients. Almost 12% of patients taking phentermine/topiramate-SR reported paresthesias. No patients stopped taking their medication because of side effects, however.

The study was a review of patients seen at the Mayo Clinic during January 2016 – June 2018. Patients were included if they were prescribed weight loss medications and had a body mass index of at least 25 kg/m² with comorbidities related to adiposity or with a BMI of at least 30 without such comorbidities. To be included, patients had to be followed for at least 3 months and see a Mayo Clinic physician at least twice.

Patients with previous bariatric surgery or other major gastrointestinal surgery, those who didn’t use their medications because of insurance problems or drug costs, and those who were on weight loss medication before being seen for the first time were excluded from the study.

Patients were a mean 49 years old, and most were female (86/118; 72.9%). Mean BMI at enrollment was 41.7, with a mean weight of 117.6 kg.

Of 118 patients, 76 (64.4%) had dyslipidemia. About half of patients reported obstructive sleep apnea, and the same amount had hypertension. About 40% had diabetes, and the same number had degenerative joint disease.

Phentermine/topiramate was prescribed the most frequently, with 43.2% of patients on this medication. Liraglutide was taken by 34.7% of patients, bupropion/naltrexone-SR by 16.1%, and lorcaserin by 5.9%.

Patients taking liraglutide had similar weight loss (7.1%) to that seen in RCTs (6%-8%). For this medication, the real-world Mayo Clinic experience showed less chance of hitting the 10% total body weight loss mark (12% vs. 26%-33% in RCTs).

For bupropion/naltrexone-SR, weight loss was similar among the Mayo Clinic patients (7.2%) and RCT participants (5%-8%), and probability of achieving at least 10% total body weight loss was similar as well (32% vs. 34%).

Weight loss medication was a component of a multidisciplinary weight loss approach at Mayo Clinic. Physicians, dietitians, and psychologists worked together to care for patients with overweight and obesity at his facility, Dr. Calderon said. Overall, patients were followed for a mean 6.7 months, and patients had a mean 3 follow-up visits, with over half of patients attending at least one follow-up appointment in study months 6-12. At 12 months, though, the attrition rate was 57.9%. “We notice an attrition rate of almost 60% at 1 year. People are not coming to their follow-up. ... Definitely, this is something we are concerned about, and we would like to bring these attrition rates lower,” he said.

Most patients (63.6%) saw a dietitian, but on average, patients had just one appointment. “At the Mayo Clinic, we provide dietitians and psychological support. But it’s up to the patients if they want to have it or not,” said Dr. Calderon. “Most of them, they just went once to a dietitian.”

“Overall, these outcomes are similar to those in RCTs and support the concept that weight loss medications can achieve clinically significant weight loss in a multidisciplinary weight loss program,” noted Dr. Calderon and his coauthors.

Dr. Calderon reported no outside sources of funding and no conflicts of interest.

[email protected]

SOURCE: Calderon G et al. Obesity Week, Abstract T-P-3425.

NASHVILLE, TENN. – Patients who took a fixed-dose combination of phentermine and topiramate–extended release (ER) lost over 15% of their body weight at 12 months, according to real-world experience from the Mayo Clinic in Rochester, Minn.

Kari Oakes/MDedge News

The results seen with the medication combo – a mean 15.5% total body weight loss at 12 months – bested the 8%-11% seen in randomized controlled trials (RCTs), said Gerardo Calderon, MD, in an interview during a poster session at Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery. The combination was also the most commonly prescribed weight loss medication at the Mayo Clinic, where Dr. Calderon is a gastroenterology and hepatology research fellow.

Patients taking lorcaserin at the Mayo Clinic also lost more weight loss than RCT participants (8.8% vs. 5%-6%, respectively). Notably, they also had a higher probability of losing at least 10% of their baseline total body weight (40% vs. 17%-23% in clinical trials). In RCTs, 37%-48% of patients taking phentermine/topiramate-ER had a total body weight loss of at least 10%, similar to the Mayo Clinic’s figure of 49%.

The rate of reported adverse events – 23.8% – exceeded that reported in RCTs, noted Dr. Calderon. Gastrointestinal symptoms, such as nausea, vomiting, diarrhea, and constipation, were reported by 2%-20% of patients across the various drugs prescribed. Insomnia and mood changes, along with dizziness or lightheadedness, were reported by 2%-6% of patients. Almost 12% of patients taking phentermine/topiramate-SR reported paresthesias. No patients stopped taking their medication because of side effects, however.

The study was a review of patients seen at the Mayo Clinic during January 2016 – June 2018. Patients were included if they were prescribed weight loss medications and had a body mass index of at least 25 kg/m² with comorbidities related to adiposity or with a BMI of at least 30 without such comorbidities. To be included, patients had to be followed for at least 3 months and see a Mayo Clinic physician at least twice.

Patients with previous bariatric surgery or other major gastrointestinal surgery, those who didn’t use their medications because of insurance problems or drug costs, and those who were on weight loss medication before being seen for the first time were excluded from the study.

Patients were a mean 49 years old, and most were female (86/118; 72.9%). Mean BMI at enrollment was 41.7, with a mean weight of 117.6 kg.

Of 118 patients, 76 (64.4%) had dyslipidemia. About half of patients reported obstructive sleep apnea, and the same amount had hypertension. About 40% had diabetes, and the same number had degenerative joint disease.

Phentermine/topiramate was prescribed the most frequently, with 43.2% of patients on this medication. Liraglutide was taken by 34.7% of patients, bupropion/naltrexone-SR by 16.1%, and lorcaserin by 5.9%.

Patients taking liraglutide had similar weight loss (7.1%) to that seen in RCTs (6%-8%). For this medication, the real-world Mayo Clinic experience showed less chance of hitting the 10% total body weight loss mark (12% vs. 26%-33% in RCTs).

For bupropion/naltrexone-SR, weight loss was similar among the Mayo Clinic patients (7.2%) and RCT participants (5%-8%), and probability of achieving at least 10% total body weight loss was similar as well (32% vs. 34%).

Weight loss medication was a component of a multidisciplinary weight loss approach at Mayo Clinic. Physicians, dietitians, and psychologists worked together to care for patients with overweight and obesity at his facility, Dr. Calderon said. Overall, patients were followed for a mean 6.7 months, and patients had a mean 3 follow-up visits, with over half of patients attending at least one follow-up appointment in study months 6-12. At 12 months, though, the attrition rate was 57.9%. “We notice an attrition rate of almost 60% at 1 year. People are not coming to their follow-up. ... Definitely, this is something we are concerned about, and we would like to bring these attrition rates lower,” he said.

Most patients (63.6%) saw a dietitian, but on average, patients had just one appointment. “At the Mayo Clinic, we provide dietitians and psychological support. But it’s up to the patients if they want to have it or not,” said Dr. Calderon. “Most of them, they just went once to a dietitian.”

“Overall, these outcomes are similar to those in RCTs and support the concept that weight loss medications can achieve clinically significant weight loss in a multidisciplinary weight loss program,” noted Dr. Calderon and his coauthors.

Dr. Calderon reported no outside sources of funding and no conflicts of interest.

[email protected]

SOURCE: Calderon G et al. Obesity Week, Abstract T-P-3425.

NASHVILLE – Digital apps for weight loss are ubiquitous, but do they work as a standalone intervention? So far, the evidence is scant, according to a new systematic review.

Beginning with a pool of 1,380 publications, Christina Hopkins and her colleagues at Duke University, Durham, N.C., eventually identified just nine trials of all-digital interventions for weight loss that met their inclusion criteria.

Presenting their findings at a late-breaking poster session during Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery, Ms. Hopkins, a clinical psychology graduate student at Duke, and her colleagues found that three of the nine studies showed statistically significant weight loss, compared with a control state. Absolute weight loss in these three trials ranged from 3 kg to about 7 kg (between-group differences, P less than .001 for all).

Participants in another trial didn’t lose a statistically significant amount of weight, compared with the control arm of the study. However, the mean 5 kg lost by those in the intervention arm was enough to be clinically significant, so Ms. Hopkins and her colleagues included this study in a subanalysis that looked for effective modalities and interventions among the studies with significant results.

The duration of the studies ranged from 6 to 24 months, though five of the trials were less than 1 year long. Women made up the majority of participants in all but one trial.

“There is limited evidence that standalone digital weight-loss interventions produce clinically meaningful outcomes,” wrote Ms. Hopkins and her coauthors. “Absolute magnitude of weight loss was low, and the short intervention lengths call into question the sustainability of these weight losses.”

The systematic review cast a broad net to include digital modalities such as wireless scales, text messaging, email, and web-based interventions, as well as the use of smartphone apps and tracking devices. All interventions used multiple digital modalities.

The most frequently used technologies were the use of a website, used in six (67%) of the trials, followed by text messaging and smartphone apps, each used in five (56%) of the trials. Tracking devices, email, message boards, and gamification of some sort were all used in three (33%) of the trials.

In terms of the specific interventions used in the trials, weight, diet, and activity were all tracked in eight trials (89%). Similarly, all but one trial gave feedback and weight and health education to participants. Behavior change education, as well as calorie goals, were each used in six trials (67%).

Ms. Hopkins and her colleagues looked at which trials incorporated which modalities and interventions, finding that “trials that integrated components unique to digital interventions, such as gamification, podcasts, or interactive features, yielded significantly greater and more clinically meaningful weight losses.”

To be included in the systematic review, trials had to include adult participants with a body mass index of at least 25 kg/m2 and use a standalone digital intervention of at least 6 months’ duration. The primary outcome of interest in the review was the change in participant weight from baseline to the end of the minimum 6-month follow-up period. Randomized, controlled trials and feasibility trials were included, so long as participants were allocated randomly.

Of the 126 trials reviewed at the full text level, the most frequent reason for exclusion was the inclusion of human coaching. Also, 30 of the trials didn’t report weight change as an outcome, the investigators said.

Future directions should include comparing digital interventions that “utilize features unique to digital delivery” with those that more closely resemble in-person weight-loss management interventions, suggested Ms. Hopkins and her collaborators.

The authors reported no outside sources of funding and no conflicts of interest.

[email protected]

SOURCE: Hopkins C et al. Obesity Week 2018, Abstract T-P-LB-3640.

NASHVILLE – Digital apps for weight loss are ubiquitous, but do they work as a standalone intervention? So far, the evidence is scant, according to a new systematic review.

Beginning with a pool of 1,380 publications, Christina Hopkins and her colleagues at Duke University, Durham, N.C., eventually identified just nine trials of all-digital interventions for weight loss that met their inclusion criteria.

Presenting their findings at a late-breaking poster session during Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery, Ms. Hopkins, a clinical psychology graduate student at Duke, and her colleagues found that three of the nine studies showed statistically significant weight loss, compared with a control state. Absolute weight loss in these three trials ranged from 3 kg to about 7 kg (between-group differences, P less than .001 for all).

Participants in another trial didn’t lose a statistically significant amount of weight, compared with the control arm of the study. However, the mean 5 kg lost by those in the intervention arm was enough to be clinically significant, so Ms. Hopkins and her colleagues included this study in a subanalysis that looked for effective modalities and interventions among the studies with significant results.

The duration of the studies ranged from 6 to 24 months, though five of the trials were less than 1 year long. Women made up the majority of participants in all but one trial.

“There is limited evidence that standalone digital weight-loss interventions produce clinically meaningful outcomes,” wrote Ms. Hopkins and her coauthors. “Absolute magnitude of weight loss was low, and the short intervention lengths call into question the sustainability of these weight losses.”

The systematic review cast a broad net to include digital modalities such as wireless scales, text messaging, email, and web-based interventions, as well as the use of smartphone apps and tracking devices. All interventions used multiple digital modalities.

The most frequently used technologies were the use of a website, used in six (67%) of the trials, followed by text messaging and smartphone apps, each used in five (56%) of the trials. Tracking devices, email, message boards, and gamification of some sort were all used in three (33%) of the trials.

In terms of the specific interventions used in the trials, weight, diet, and activity were all tracked in eight trials (89%). Similarly, all but one trial gave feedback and weight and health education to participants. Behavior change education, as well as calorie goals, were each used in six trials (67%).

Ms. Hopkins and her colleagues looked at which trials incorporated which modalities and interventions, finding that “trials that integrated components unique to digital interventions, such as gamification, podcasts, or interactive features, yielded significantly greater and more clinically meaningful weight losses.”

To be included in the systematic review, trials had to include adult participants with a body mass index of at least 25 kg/m2 and use a standalone digital intervention of at least 6 months’ duration. The primary outcome of interest in the review was the change in participant weight from baseline to the end of the minimum 6-month follow-up period. Randomized, controlled trials and feasibility trials were included, so long as participants were allocated randomly.

Of the 126 trials reviewed at the full text level, the most frequent reason for exclusion was the inclusion of human coaching. Also, 30 of the trials didn’t report weight change as an outcome, the investigators said.

Future directions should include comparing digital interventions that “utilize features unique to digital delivery” with those that more closely resemble in-person weight-loss management interventions, suggested Ms. Hopkins and her collaborators.

The authors reported no outside sources of funding and no conflicts of interest.

[email protected]

SOURCE: Hopkins C et al. Obesity Week 2018, Abstract T-P-LB-3640.

NASHVILLE – Digital apps for weight loss are ubiquitous, but do they work as a standalone intervention? So far, the evidence is scant, according to a new systematic review.

Beginning with a pool of 1,380 publications, Christina Hopkins and her colleagues at Duke University, Durham, N.C., eventually identified just nine trials of all-digital interventions for weight loss that met their inclusion criteria.

Presenting their findings at a late-breaking poster session during Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery, Ms. Hopkins, a clinical psychology graduate student at Duke, and her colleagues found that three of the nine studies showed statistically significant weight loss, compared with a control state. Absolute weight loss in these three trials ranged from 3 kg to about 7 kg (between-group differences, P less than .001 for all).

Participants in another trial didn’t lose a statistically significant amount of weight, compared with the control arm of the study. However, the mean 5 kg lost by those in the intervention arm was enough to be clinically significant, so Ms. Hopkins and her colleagues included this study in a subanalysis that looked for effective modalities and interventions among the studies with significant results.

The duration of the studies ranged from 6 to 24 months, though five of the trials were less than 1 year long. Women made up the majority of participants in all but one trial.

“There is limited evidence that standalone digital weight-loss interventions produce clinically meaningful outcomes,” wrote Ms. Hopkins and her coauthors. “Absolute magnitude of weight loss was low, and the short intervention lengths call into question the sustainability of these weight losses.”

The systematic review cast a broad net to include digital modalities such as wireless scales, text messaging, email, and web-based interventions, as well as the use of smartphone apps and tracking devices. All interventions used multiple digital modalities.

The most frequently used technologies were the use of a website, used in six (67%) of the trials, followed by text messaging and smartphone apps, each used in five (56%) of the trials. Tracking devices, email, message boards, and gamification of some sort were all used in three (33%) of the trials.

In terms of the specific interventions used in the trials, weight, diet, and activity were all tracked in eight trials (89%). Similarly, all but one trial gave feedback and weight and health education to participants. Behavior change education, as well as calorie goals, were each used in six trials (67%).

Ms. Hopkins and her colleagues looked at which trials incorporated which modalities and interventions, finding that “trials that integrated components unique to digital interventions, such as gamification, podcasts, or interactive features, yielded significantly greater and more clinically meaningful weight losses.”

To be included in the systematic review, trials had to include adult participants with a body mass index of at least 25 kg/m2 and use a standalone digital intervention of at least 6 months’ duration. The primary outcome of interest in the review was the change in participant weight from baseline to the end of the minimum 6-month follow-up period. Randomized, controlled trials and feasibility trials were included, so long as participants were allocated randomly.

Of the 126 trials reviewed at the full text level, the most frequent reason for exclusion was the inclusion of human coaching. Also, 30 of the trials didn’t report weight change as an outcome, the investigators said.

Future directions should include comparing digital interventions that “utilize features unique to digital delivery” with those that more closely resemble in-person weight-loss management interventions, suggested Ms. Hopkins and her collaborators.

The authors reported no outside sources of funding and no conflicts of interest.

[email protected]

SOURCE: Hopkins C et al. Obesity Week 2018, Abstract T-P-LB-3640.

A novel intervention that brought training to barbers, and pharmacists to barbershops, resulted in marked and sustained reduction in blood pressure for a black male cohort of participants, according to 12-month data from the project.

© Bonnie Schupp

Of the 319 black, non-Hispanic male participants, 180 were randomized to participate in an intensive 6-month hypertension intervention. The study protocol allowed pharmacists, who visited participants at their barbershops, to prescribe hypertension medication under collaborative practice agreements with participants’ primary care providers (PCPs).

Compared with an active control group who received instruction about blood pressure and lifestyle modification, participants receiving the intervention saw significant reductions in systolic BP at 6 months (N Engl J Med. 2018 Apr 5;378:1291-391). From 6 months onward, participants in the intervention arm received fewer visits from pharmacists, though they still regularly visited the barbershop, where blood pressure was recorded. At the end of 12 months, systolic BP – at least 140 mm Hg at enrollment – dropped by 28.6 mm Hg from baseline in the intervention group to a mean 123.8 mm Hg. For those in the control group, the reduction in systolic BP was 7.2 mm Hg, to a mean 147.4 mm Hg. This 20.8-point difference between the two groups was highly statistically significant (P less than .0001).

“These new 12-month efficacy data are statistically indistinguishable from our previously reported 6-month data,” wrote Ciantal Blyler, PharmD, a clinical pharmacist at Cedars-Sinai Medical Center, Los Angeles, and her coauthors.

Diastolic BP, a secondary outcome measure, fell in the intervention group by 14.5 mm Hg more than in the active controls. In the intervention arm, 68% of participants reached the prespecified goal blood pressure of less than 130/80 mm Hg, while just 11% of the control group hit this target, a significant difference.

No trial participants experienced treatment-related adverse events or deaths during the 6-month extension phase.

Compared with men in the active control arm, those receiving the intervention were on a greater number of antihypertensive classes per regimen. Also, patients receiving the intervention were more likely to receive first-line drugs as add-on therapy. At the end of the 12-month period, all participants in the intensive arm were on antihypertensives, up from 57% at baseline. For the control group, antihypertensive medication use went from 53% at baseline to 65% at 6 months (P less than .001).

The intervention group saw their PCP more frequently than did the control group during the study; there was no difference in PCP visit frequency at baseline. “This suggests that the pharmacist intervention did not interfere with the patient-PCP relationship, and perhaps influenced the increase in PCP visits,” noted Dr. Blyler and her colleagues.

The investigators noted that the pharmacists’ ability to begin, titrate, and change hypertension medication under a collaborative agreement with physicians was an essential part of the program’s initial and continued success. “Perhaps the most critical first step toward widespread dissemination of our model is the expansion of collaborative practice between pharmacists and physicians, or the elimination of the requirement altogether (as in Canada and the UK),” wrote Dr. Blyler and her coauthors.

Beyond that, Dr. Blyler and her colleagues said that scalability will depend on the ability to adapt the model to create operational efficiencies while maintaining intervention potency. The time it took pharmacists to get to and from barbershops was significant, and some form of telemonitoring may work well going forward as “an appropriate means of maintaining/sustaining the intervention effect whilst also addressing this logistical inefficiency,” they said.

The study was funded by the National Institutes of Health, the California Endowment, the Lincy Foundation, the Harriet and Steven Nichols Foundation, the Smidt Heart Institute, and the Division of Community Relations and Development at Cedars-Sinai Medical Center, Los Angeles. One coauthor reported being a consultant for Recor Medical; other authors reported that they had no disclosures.

[email protected]

SOURCE: Blyler C et al. Circulation. 2018 Dec 17.

A novel intervention that brought training to barbers, and pharmacists to barbershops, resulted in marked and sustained reduction in blood pressure for a black male cohort of participants, according to 12-month data from the project.

© Bonnie Schupp

Of the 319 black, non-Hispanic male participants, 180 were randomized to participate in an intensive 6-month hypertension intervention. The study protocol allowed pharmacists, who visited participants at their barbershops, to prescribe hypertension medication under collaborative practice agreements with participants’ primary care providers (PCPs).

Compared with an active control group who received instruction about blood pressure and lifestyle modification, participants receiving the intervention saw significant reductions in systolic BP at 6 months (N Engl J Med. 2018 Apr 5;378:1291-391). From 6 months onward, participants in the intervention arm received fewer visits from pharmacists, though they still regularly visited the barbershop, where blood pressure was recorded. At the end of 12 months, systolic BP – at least 140 mm Hg at enrollment – dropped by 28.6 mm Hg from baseline in the intervention group to a mean 123.8 mm Hg. For those in the control group, the reduction in systolic BP was 7.2 mm Hg, to a mean 147.4 mm Hg. This 20.8-point difference between the two groups was highly statistically significant (P less than .0001).

“These new 12-month efficacy data are statistically indistinguishable from our previously reported 6-month data,” wrote Ciantal Blyler, PharmD, a clinical pharmacist at Cedars-Sinai Medical Center, Los Angeles, and her coauthors.

Diastolic BP, a secondary outcome measure, fell in the intervention group by 14.5 mm Hg more than in the active controls. In the intervention arm, 68% of participants reached the prespecified goal blood pressure of less than 130/80 mm Hg, while just 11% of the control group hit this target, a significant difference.

No trial participants experienced treatment-related adverse events or deaths during the 6-month extension phase.

Compared with men in the active control arm, those receiving the intervention were on a greater number of antihypertensive classes per regimen. Also, patients receiving the intervention were more likely to receive first-line drugs as add-on therapy. At the end of the 12-month period, all participants in the intensive arm were on antihypertensives, up from 57% at baseline. For the control group, antihypertensive medication use went from 53% at baseline to 65% at 6 months (P less than .001).

The intervention group saw their PCP more frequently than did the control group during the study; there was no difference in PCP visit frequency at baseline. “This suggests that the pharmacist intervention did not interfere with the patient-PCP relationship, and perhaps influenced the increase in PCP visits,” noted Dr. Blyler and her colleagues.

The investigators noted that the pharmacists’ ability to begin, titrate, and change hypertension medication under a collaborative agreement with physicians was an essential part of the program’s initial and continued success. “Perhaps the most critical first step toward widespread dissemination of our model is the expansion of collaborative practice between pharmacists and physicians, or the elimination of the requirement altogether (as in Canada and the UK),” wrote Dr. Blyler and her coauthors.

Beyond that, Dr. Blyler and her colleagues said that scalability will depend on the ability to adapt the model to create operational efficiencies while maintaining intervention potency. The time it took pharmacists to get to and from barbershops was significant, and some form of telemonitoring may work well going forward as “an appropriate means of maintaining/sustaining the intervention effect whilst also addressing this logistical inefficiency,” they said.

The study was funded by the National Institutes of Health, the California Endowment, the Lincy Foundation, the Harriet and Steven Nichols Foundation, the Smidt Heart Institute, and the Division of Community Relations and Development at Cedars-Sinai Medical Center, Los Angeles. One coauthor reported being a consultant for Recor Medical; other authors reported that they had no disclosures.

[email protected]

SOURCE: Blyler C et al. Circulation. 2018 Dec 17.

A novel intervention that brought training to barbers, and pharmacists to barbershops, resulted in marked and sustained reduction in blood pressure for a black male cohort of participants, according to 12-month data from the project.

© Bonnie Schupp

Of the 319 black, non-Hispanic male participants, 180 were randomized to participate in an intensive 6-month hypertension intervention. The study protocol allowed pharmacists, who visited participants at their barbershops, to prescribe hypertension medication under collaborative practice agreements with participants’ primary care providers (PCPs).

Compared with an active control group who received instruction about blood pressure and lifestyle modification, participants receiving the intervention saw significant reductions in systolic BP at 6 months (N Engl J Med. 2018 Apr 5;378:1291-391). From 6 months onward, participants in the intervention arm received fewer visits from pharmacists, though they still regularly visited the barbershop, where blood pressure was recorded. At the end of 12 months, systolic BP – at least 140 mm Hg at enrollment – dropped by 28.6 mm Hg from baseline in the intervention group to a mean 123.8 mm Hg. For those in the control group, the reduction in systolic BP was 7.2 mm Hg, to a mean 147.4 mm Hg. This 20.8-point difference between the two groups was highly statistically significant (P less than .0001).

“These new 12-month efficacy data are statistically indistinguishable from our previously reported 6-month data,” wrote Ciantal Blyler, PharmD, a clinical pharmacist at Cedars-Sinai Medical Center, Los Angeles, and her coauthors.

Diastolic BP, a secondary outcome measure, fell in the intervention group by 14.5 mm Hg more than in the active controls. In the intervention arm, 68% of participants reached the prespecified goal blood pressure of less than 130/80 mm Hg, while just 11% of the control group hit this target, a significant difference.

No trial participants experienced treatment-related adverse events or deaths during the 6-month extension phase.

Compared with men in the active control arm, those receiving the intervention were on a greater number of antihypertensive classes per regimen. Also, patients receiving the intervention were more likely to receive first-line drugs as add-on therapy. At the end of the 12-month period, all participants in the intensive arm were on antihypertensives, up from 57% at baseline. For the control group, antihypertensive medication use went from 53% at baseline to 65% at 6 months (P less than .001).

The intervention group saw their PCP more frequently than did the control group during the study; there was no difference in PCP visit frequency at baseline. “This suggests that the pharmacist intervention did not interfere with the patient-PCP relationship, and perhaps influenced the increase in PCP visits,” noted Dr. Blyler and her colleagues.

The investigators noted that the pharmacists’ ability to begin, titrate, and change hypertension medication under a collaborative agreement with physicians was an essential part of the program’s initial and continued success. “Perhaps the most critical first step toward widespread dissemination of our model is the expansion of collaborative practice between pharmacists and physicians, or the elimination of the requirement altogether (as in Canada and the UK),” wrote Dr. Blyler and her coauthors.

Beyond that, Dr. Blyler and her colleagues said that scalability will depend on the ability to adapt the model to create operational efficiencies while maintaining intervention potency. The time it took pharmacists to get to and from barbershops was significant, and some form of telemonitoring may work well going forward as “an appropriate means of maintaining/sustaining the intervention effect whilst also addressing this logistical inefficiency,” they said.

The study was funded by the National Institutes of Health, the California Endowment, the Lincy Foundation, the Harriet and Steven Nichols Foundation, the Smidt Heart Institute, and the Division of Community Relations and Development at Cedars-Sinai Medical Center, Los Angeles. One coauthor reported being a consultant for Recor Medical; other authors reported that they had no disclosures.

[email protected]

SOURCE: Blyler C et al. Circulation. 2018 Dec 17.

NASHVILLE – Advising patients in a comprehensive weight loss intervention to moderate their alcohol consumption did not change how much they drank over the long term. At the same time, abstinent patients kept off more weight over time than those who were classified as heavy drinkers, in a new analysis of data from a multicenter trial.

Kari Oakes/MDedge News

Abstinent individuals lost just 1.6% more of their body weight after 4 years than those who drank (P = .003), a figure with “uncertain clinical significance,” Ariana Chao, PhD, said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery. “The results should be taken in the context of the potential – though controversial – benefits of light to moderate alcohol consumption,” she added.

Alcohol contains 7.1 kcal/g, and “calories from alcohol usually add, rather than substitute, for food intake,” said Dr. Chao. Alcohol’s disinhibiting effects are thought to contribute to increased food intake and the making of less healthy food choices. However, existing research has shown inconsistent findings about the relationship between alcohol consumption and body weight, she said.

Reducing or completely cutting out alcoholic beverage consumption is common advice for those trying to lose weight, but whether this advice is followed, and whether it makes a difference over the long term, has been an open question, said Dr. Chao.

She and her collaborators at the University of Pennsylvania, Philadelphia, used data from Look AHEAD, “a multicenter, randomized, clinical trial that compared an intensive lifestyle intervention (ILI) to a diabetes support and education (DSE) control group,” for 5,145 people with overweight or obesity and type 2 diabetes, explained Dr. Chao and her coinvestigators.

Dr. Chao and her colleagues looked at the effect that the lifestyle intervention had on alcohol consumption. Additionally, to see how drinkers and nondrinkers fared over the long term, they examined the interaction between alcohol consumption and weight loss at year 4, hypothesizing that individuals who received ILI would have a greater decrease in their alcohol consumption by year 4 than those who received DSE. The investigators had a second hypothesis that, among the ILI cohort, greater alcohol consumption would be associated with less weight loss over the 4 years studied.

To measure alcohol consumption, participants completed a questionnaire at baseline and annually thereafter. The questionnaire asked whether participants had consumed any alcoholic beverages in the past week, and how many drinks per week of wine, beer, or liquor per week were typical for those who did consume alcohol.

Respondents were grouped into four categories according to their baseline alcohol consumption: nondrinkers, light drinkers (fewer than 7 drinks weekly for men and 4 for women), moderate drinkers (7-14 drinks weekly for men and 4-7 for women), and heavy drinkers (more than 14 drinks weekly for men and 7 for women).

At baseline, 38% of participants reported being abstinent from alcohol, and about 54% reported being light drinkers. Moderate drinkers made up 6%, and 2% reported falling into the heavy drinking category. Females were more likely than males to be nondrinkers.

Heavy drinkers took in significantly more calories than nondrinkers at baseline (2,397 versus 1,907 kcal/day; P less than .001).

Individuals who had consistently been heavy drinkers throughout the study lost less weight than any other group, dropping just 2.4% of their body weight at year 4, compared with their baseline weight. Those who were abstinent from alcohol fared the best, losing 5.1% of their initial body weight (P = .04 for difference). “Heavy drinking is a risk factor for suboptimal long-term weight loss,” said Dr. Chao.

Even those who were consistent light drinkers lost a bit less than those who were abstinent, keeping off 4.2% of their baseline body weight at 4 years (P = .04).

Look AHEAD included individuals aged 45-76 years with type 2 diabetes mellitus and a body mass index of at least 25 kg/m², or 27 kg/m² for those on insulin. Excluded were those with hemoglobin A_1c of at least 11%, blood pressure of at least 160/100 mm Hg, and triglycerides over 600 mg/dL. A total of 4,901 patients had complete data available in the public access data set and were included in the present analysis. Dr. Chao and her colleagues used statistical techniques to adjust for baseline differences among participants.

The three-part ILI in Look AHEAD began by encouraging a low-calorie diet of 1,200-1,500 kcal/day for those weighing under 250 pounds, and 1,500-1,800 kcal/day for those who were heavier at baseline. Advice was to consume a balanced diet with less than 30% fat, less than 10% saturated fat, and at least 15% protein.

Patients were advised to strive for 10,000 steps per day, with 175 minutes of moderate-intensity exercise each week. Exercise was unsupervised.

Behavioral modification techniques included goal-setting, stimulus control, self-monitoring, and ideas for problem solving and relapse prevention. The intervention used motivational interviewing techniques.

With regard to alcohol, the ILI group was given information about the number of calories in various alcoholic beverages and advised to reduce the amount of alcohol consumed, in order to reduce calories.

The DSE group participated in three group sessions annually, and received general information about nutrition, exercise, and general support.

A potentially important limitation of the study was that alcohol consumption was assessed by self-report and a request for annual recall of typical drinking habits. An audience member from the United Kingdom commented that she found the overall rate of reported alcohol consumption to be “shockingly low,” compared with what her patients report drinking in England. The average United States resident drinks 2.3 gallons of alcohol, or 494 standard drinks, annually, according to the National Institute on Alcohol Abuse and Alcoholism, said Dr. Chao.

The midlife age range of participants, their diabetes diagnosis, and the fact that depressive symptoms were overall low limits generalizability of the findings, said Dr. Chao, adding that psychosocial factors, other health conditions, and current or past alcohol use disorder could also cause some residual confounding of the data.

Dr. Chao has received research support from Shire Pharmaceuticals.

[email protected]

SOURCE: Chao A et al. Obesity Week 2018, Abstract T-OR-2017.

NASHVILLE – Advising patients in a comprehensive weight loss intervention to moderate their alcohol consumption did not change how much they drank over the long term. At the same time, abstinent patients kept off more weight over time than those who were classified as heavy drinkers, in a new analysis of data from a multicenter trial.

Kari Oakes/MDedge News

Abstinent individuals lost just 1.6% more of their body weight after 4 years than those who drank (P = .003), a figure with “uncertain clinical significance,” Ariana Chao, PhD, said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery. “The results should be taken in the context of the potential – though controversial – benefits of light to moderate alcohol consumption,” she added.

Alcohol contains 7.1 kcal/g, and “calories from alcohol usually add, rather than substitute, for food intake,” said Dr. Chao. Alcohol’s disinhibiting effects are thought to contribute to increased food intake and the making of less healthy food choices. However, existing research has shown inconsistent findings about the relationship between alcohol consumption and body weight, she said.

Reducing or completely cutting out alcoholic beverage consumption is common advice for those trying to lose weight, but whether this advice is followed, and whether it makes a difference over the long term, has been an open question, said Dr. Chao.

She and her collaborators at the University of Pennsylvania, Philadelphia, used data from Look AHEAD, “a multicenter, randomized, clinical trial that compared an intensive lifestyle intervention (ILI) to a diabetes support and education (DSE) control group,” for 5,145 people with overweight or obesity and type 2 diabetes, explained Dr. Chao and her coinvestigators.

Dr. Chao and her colleagues looked at the effect that the lifestyle intervention had on alcohol consumption. Additionally, to see how drinkers and nondrinkers fared over the long term, they examined the interaction between alcohol consumption and weight loss at year 4, hypothesizing that individuals who received ILI would have a greater decrease in their alcohol consumption by year 4 than those who received DSE. The investigators had a second hypothesis that, among the ILI cohort, greater alcohol consumption would be associated with less weight loss over the 4 years studied.

To measure alcohol consumption, participants completed a questionnaire at baseline and annually thereafter. The questionnaire asked whether participants had consumed any alcoholic beverages in the past week, and how many drinks per week of wine, beer, or liquor per week were typical for those who did consume alcohol.

Respondents were grouped into four categories according to their baseline alcohol consumption: nondrinkers, light drinkers (fewer than 7 drinks weekly for men and 4 for women), moderate drinkers (7-14 drinks weekly for men and 4-7 for women), and heavy drinkers (more than 14 drinks weekly for men and 7 for women).

At baseline, 38% of participants reported being abstinent from alcohol, and about 54% reported being light drinkers. Moderate drinkers made up 6%, and 2% reported falling into the heavy drinking category. Females were more likely than males to be nondrinkers.

Heavy drinkers took in significantly more calories than nondrinkers at baseline (2,397 versus 1,907 kcal/day; P less than .001).

Individuals who had consistently been heavy drinkers throughout the study lost less weight than any other group, dropping just 2.4% of their body weight at year 4, compared with their baseline weight. Those who were abstinent from alcohol fared the best, losing 5.1% of their initial body weight (P = .04 for difference). “Heavy drinking is a risk factor for suboptimal long-term weight loss,” said Dr. Chao.

Even those who were consistent light drinkers lost a bit less than those who were abstinent, keeping off 4.2% of their baseline body weight at 4 years (P = .04).

Look AHEAD included individuals aged 45-76 years with type 2 diabetes mellitus and a body mass index of at least 25 kg/m², or 27 kg/m² for those on insulin. Excluded were those with hemoglobin A_1c of at least 11%, blood pressure of at least 160/100 mm Hg, and triglycerides over 600 mg/dL. A total of 4,901 patients had complete data available in the public access data set and were included in the present analysis. Dr. Chao and her colleagues used statistical techniques to adjust for baseline differences among participants.

The three-part ILI in Look AHEAD began by encouraging a low-calorie diet of 1,200-1,500 kcal/day for those weighing under 250 pounds, and 1,500-1,800 kcal/day for those who were heavier at baseline. Advice was to consume a balanced diet with less than 30% fat, less than 10% saturated fat, and at least 15% protein.

Patients were advised to strive for 10,000 steps per day, with 175 minutes of moderate-intensity exercise each week. Exercise was unsupervised.

Behavioral modification techniques included goal-setting, stimulus control, self-monitoring, and ideas for problem solving and relapse prevention. The intervention used motivational interviewing techniques.

With regard to alcohol, the ILI group was given information about the number of calories in various alcoholic beverages and advised to reduce the amount of alcohol consumed, in order to reduce calories.

The DSE group participated in three group sessions annually, and received general information about nutrition, exercise, and general support.

A potentially important limitation of the study was that alcohol consumption was assessed by self-report and a request for annual recall of typical drinking habits. An audience member from the United Kingdom commented that she found the overall rate of reported alcohol consumption to be “shockingly low,” compared with what her patients report drinking in England. The average United States resident drinks 2.3 gallons of alcohol, or 494 standard drinks, annually, according to the National Institute on Alcohol Abuse and Alcoholism, said Dr. Chao.

The midlife age range of participants, their diabetes diagnosis, and the fact that depressive symptoms were overall low limits generalizability of the findings, said Dr. Chao, adding that psychosocial factors, other health conditions, and current or past alcohol use disorder could also cause some residual confounding of the data.

Dr. Chao has received research support from Shire Pharmaceuticals.

[email protected]

SOURCE: Chao A et al. Obesity Week 2018, Abstract T-OR-2017.

NASHVILLE – Advising patients in a comprehensive weight loss intervention to moderate their alcohol consumption did not change how much they drank over the long term. At the same time, abstinent patients kept off more weight over time than those who were classified as heavy drinkers, in a new analysis of data from a multicenter trial.

Kari Oakes/MDedge News

Abstinent individuals lost just 1.6% more of their body weight after 4 years than those who drank (P = .003), a figure with “uncertain clinical significance,” Ariana Chao, PhD, said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery. “The results should be taken in the context of the potential – though controversial – benefits of light to moderate alcohol consumption,” she added.

Alcohol contains 7.1 kcal/g, and “calories from alcohol usually add, rather than substitute, for food intake,” said Dr. Chao. Alcohol’s disinhibiting effects are thought to contribute to increased food intake and the making of less healthy food choices. However, existing research has shown inconsistent findings about the relationship between alcohol consumption and body weight, she said.

Reducing or completely cutting out alcoholic beverage consumption is common advice for those trying to lose weight, but whether this advice is followed, and whether it makes a difference over the long term, has been an open question, said Dr. Chao.

She and her collaborators at the University of Pennsylvania, Philadelphia, used data from Look AHEAD, “a multicenter, randomized, clinical trial that compared an intensive lifestyle intervention (ILI) to a diabetes support and education (DSE) control group,” for 5,145 people with overweight or obesity and type 2 diabetes, explained Dr. Chao and her coinvestigators.

Dr. Chao and her colleagues looked at the effect that the lifestyle intervention had on alcohol consumption. Additionally, to see how drinkers and nondrinkers fared over the long term, they examined the interaction between alcohol consumption and weight loss at year 4, hypothesizing that individuals who received ILI would have a greater decrease in their alcohol consumption by year 4 than those who received DSE. The investigators had a second hypothesis that, among the ILI cohort, greater alcohol consumption would be associated with less weight loss over the 4 years studied.

To measure alcohol consumption, participants completed a questionnaire at baseline and annually thereafter. The questionnaire asked whether participants had consumed any alcoholic beverages in the past week, and how many drinks per week of wine, beer, or liquor per week were typical for those who did consume alcohol.

Respondents were grouped into four categories according to their baseline alcohol consumption: nondrinkers, light drinkers (fewer than 7 drinks weekly for men and 4 for women), moderate drinkers (7-14 drinks weekly for men and 4-7 for women), and heavy drinkers (more than 14 drinks weekly for men and 7 for women).

At baseline, 38% of participants reported being abstinent from alcohol, and about 54% reported being light drinkers. Moderate drinkers made up 6%, and 2% reported falling into the heavy drinking category. Females were more likely than males to be nondrinkers.

Heavy drinkers took in significantly more calories than nondrinkers at baseline (2,397 versus 1,907 kcal/day; P less than .001).

Individuals who had consistently been heavy drinkers throughout the study lost less weight than any other group, dropping just 2.4% of their body weight at year 4, compared with their baseline weight. Those who were abstinent from alcohol fared the best, losing 5.1% of their initial body weight (P = .04 for difference). “Heavy drinking is a risk factor for suboptimal long-term weight loss,” said Dr. Chao.

Even those who were consistent light drinkers lost a bit less than those who were abstinent, keeping off 4.2% of their baseline body weight at 4 years (P = .04).

Look AHEAD included individuals aged 45-76 years with type 2 diabetes mellitus and a body mass index of at least 25 kg/m², or 27 kg/m² for those on insulin. Excluded were those with hemoglobin A_1c of at least 11%, blood pressure of at least 160/100 mm Hg, and triglycerides over 600 mg/dL. A total of 4,901 patients had complete data available in the public access data set and were included in the present analysis. Dr. Chao and her colleagues used statistical techniques to adjust for baseline differences among participants.

The three-part ILI in Look AHEAD began by encouraging a low-calorie diet of 1,200-1,500 kcal/day for those weighing under 250 pounds, and 1,500-1,800 kcal/day for those who were heavier at baseline. Advice was to consume a balanced diet with less than 30% fat, less than 10% saturated fat, and at least 15% protein.

Patients were advised to strive for 10,000 steps per day, with 175 minutes of moderate-intensity exercise each week. Exercise was unsupervised.

Behavioral modification techniques included goal-setting, stimulus control, self-monitoring, and ideas for problem solving and relapse prevention. The intervention used motivational interviewing techniques.

With regard to alcohol, the ILI group was given information about the number of calories in various alcoholic beverages and advised to reduce the amount of alcohol consumed, in order to reduce calories.

The DSE group participated in three group sessions annually, and received general information about nutrition, exercise, and general support.

A potentially important limitation of the study was that alcohol consumption was assessed by self-report and a request for annual recall of typical drinking habits. An audience member from the United Kingdom commented that she found the overall rate of reported alcohol consumption to be “shockingly low,” compared with what her patients report drinking in England. The average United States resident drinks 2.3 gallons of alcohol, or 494 standard drinks, annually, according to the National Institute on Alcohol Abuse and Alcoholism, said Dr. Chao.

The midlife age range of participants, their diabetes diagnosis, and the fact that depressive symptoms were overall low limits generalizability of the findings, said Dr. Chao, adding that psychosocial factors, other health conditions, and current or past alcohol use disorder could also cause some residual confounding of the data.

Dr. Chao has received research support from Shire Pharmaceuticals.

[email protected]

SOURCE: Chao A et al. Obesity Week 2018, Abstract T-OR-2017.

NASHVILLE – Is there a role for weight loss medications to help manage weight regain after bariatric surgery? Perhaps, according to a recent analysis of single-center clinical data.

Phentermine and topiramate were each prescribed to between 10% and 12.5% of bariatric surgery patients at Boston Medical Center in recent years. That figure had been steadily increasing since 2004, when data collection began, Nawfal W. Istfan, MD, PhD, said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

However, the center didn’t know how patients who had received medication fared for long-term maintenance of weight loss, compared with those who had surgery alone; also, there were no clinical guidelines for prescribing weight loss medications (WLMs). “Have we done those patients any benefit by prescribing weight loss medications after gastric bypass surgery?” asked Dr. Istfan. The answer from the Boston Medical Center data is a qualified “yes;” patients with the highest rates of weight regain who were adherent to their medication did see lower rates of regain, and fewer rapid weight regain events.

Comparing patients who received prescriptions with those who did not, patients with less weight loss at nadir were more likely to receive a prescription. “This could very well be the reason they were prescribed a medication: They did not lose as much weight, and they are more likely to ask us” for WLMs, said Dr. Istfan, an endocrinologist at Boston University. However, for those who were prescribed WLMs, the slope of regain was flatter than for those who didn’t receive medication. Of the 626 patients included in the study, 91 received phentermine alone, 54 topiramate alone, and 113 were prescribed both phentermine and topiramate. Three received lorcaserin.

Those receiving medication were similar to the total bariatric surgery population in terms of age, sex, comorbidities, socioeconomic status, and preoperative body mass index, said Dr. Istfan, the senior author in the study. However, Hispanic individuals were more likely to receive WLMs, he said.

Recognizing that “the ratio of weight regain to nadir weight is more indicative of overfeeding than other parameters,” Dr. Istfan said that he and his colleagues divided patients into quartiles of regain, based on this ratio. The quartiles fell out so that those who had the least regain either lost weight or regained less than 1.4%, to make up the first quartile. The second quartile included those who regained from 1.5% to 6.26%, while the third quartile ranged up to 14.29% regain. Those who regained 14.3% or more were in the highest quartile of weight regain.

In comparing characteristics of the quartiles, there were more African Americans in the two higher quartiles (P = .017). More patients had achieved maximal weight loss in the highest quartile of regain (P less than .0001), though preoperative BMI had also been higher in this group (P = .0008).

After statistical adjustment, the investigators found that for individuals who had the highest quartile of regain, patients who were adherent to their WLMs had significantly less weight regain than those who took no medication (P = .014). However, patients considered nonadherent saw no medication effect on weight regain. The differences were small overall, with adherent patients regaining about 27% of weight relative to their nadir and those who didn’t take WLMs regaining about 30%. These significant results were seen long after bariatric surgery, at about 7 years post surgery.

In another analysis that looked just at the quartile of patients with the highest regain rate, weight regain was significantly delayed among those who were prescribed – and were adherent to – WLMs (P = .023). The analysis used a threshold weight regain rate of 1.22% per month; levels lower than that did not see a significant drug effect, and the effect was not seen for those not adherent to their WLMs.

Finally, an adjusted statistical analysis compared those taking and not taking WLMs to see whether WLMs were effective at preventing weight regain in rolling 90-day intervals throughout the study period. Again, in the highest quartile, those who were adherent to WLMs had a lower odds ratio of hitting the 1.22%/month regain rate, compared with those not taking medication (OR, 0.570; 95% confidence interval, 0.371-0.877; P = .01). The effect was not significant for the nonadherent group (OR, 0.872; 95% CI, 0.593-1.284; P = .489).

As more bariatric procedures are being done, and as more patients are living with their surgeries, physicians are seeing more weight regain, said Dr. Istfan, noting that it’s important to assess efficacy of WLMs in the postsurgical population. “Recent work showed that by 5 years after gastric bypass, half of patients had regained more than 15% of their nadir weight, and two-thirds of patients had regained more than 20% of their total maximum weight loss, said Dr. Istfan (King WC et al. JAMA.2018;320:1560).

Typically, patients will see about a 35% weight loss at their nadir, with a gradual increase in weight gain beginning about 2 years after surgery. Though it’s true that a net weight loss of 25% is still good, it can be a misleading way to look at the data, “because it does not focus on the process of weight regain itself,” said Dr. Istfan.

“Despite the maintenance of substantial weight loss, weight regain is concerning: It’s the present and future, not the past,” he said.

Regaining weight necessarily means that patients are having excess nutrient intake and a net-positive energy balance; this state can be associated with oxidative stress, inflammation, and insulin resistance – all potential contributors to the recurrence of comorbidities.

What’s to be done about weight regain, if it’s a point of concern? One option, said Dr. Istfan, is to consider more surgery. Patients might want a “re-do;” techniques that have been tried include reshaping the pouch and doing an anastomosis plication. If a gastro-gastric fistula’s developed, that can be corrected, he said.

Some factors influencing regain can be targeted by behavioral therapy. These include addressing alcohol consumption, discouraging grazing, encouraging exercise, and assessing and modifying diet quality in general.

“There is a general reluctance on the part of physicians to use weight loss medications after bariatric surgery,” said Dr. Istfan. Reasons can include concern about further nutritional compromise, especially when thinking about long-term use of appetite-suppressing medications. Importantly, there aren’t clinical guidelines for prescribing WLMs after bariatric surgery, nor is there a strong body of prospective studies in this area.

Dr. Istfan noted that the medical and surgical bariatric teams collaborate closely at Boston Medical Center to provide pre- and postoperative assessment and management.

The long observational interval and ethnic and socioeconomic diversity of the study population are strengths, said Dr. Istfan. Also, the three different multivariable models converged to similar findings.

However, the study was retrospective, with some confounding likely, and each prescriber involved in the study may have varying prescribing practices. Also, adherence was assessed by follow-up medication appointments, a measure that likely introduced some inaccuracy.

“Weight loss medications are potentially effective tools to counter weight regain after bariatric surgery; prospective studies are needed to optimize the use of weight loss medications after bariatric surgery,” said Dr. Istfan.

Dr. Istfan reported no outside sources of funding, and no conflicts of interest.

AGA provides GIs with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at http://ow.ly/fFA330mWKCn.

SOURCE: Anderson W et al. Obesity Week 2018, Abstract T-OR-2016.

NASHVILLE – Is there a role for weight loss medications to help manage weight regain after bariatric surgery? Perhaps, according to a recent analysis of single-center clinical data.

Phentermine and topiramate were each prescribed to between 10% and 12.5% of bariatric surgery patients at Boston Medical Center in recent years. That figure had been steadily increasing since 2004, when data collection began, Nawfal W. Istfan, MD, PhD, said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

However, the center didn’t know how patients who had received medication fared for long-term maintenance of weight loss, compared with those who had surgery alone; also, there were no clinical guidelines for prescribing weight loss medications (WLMs). “Have we done those patients any benefit by prescribing weight loss medications after gastric bypass surgery?” asked Dr. Istfan. The answer from the Boston Medical Center data is a qualified “yes;” patients with the highest rates of weight regain who were adherent to their medication did see lower rates of regain, and fewer rapid weight regain events.

Comparing patients who received prescriptions with those who did not, patients with less weight loss at nadir were more likely to receive a prescription. “This could very well be the reason they were prescribed a medication: They did not lose as much weight, and they are more likely to ask us” for WLMs, said Dr. Istfan, an endocrinologist at Boston University. However, for those who were prescribed WLMs, the slope of regain was flatter than for those who didn’t receive medication. Of the 626 patients included in the study, 91 received phentermine alone, 54 topiramate alone, and 113 were prescribed both phentermine and topiramate. Three received lorcaserin.

Those receiving medication were similar to the total bariatric surgery population in terms of age, sex, comorbidities, socioeconomic status, and preoperative body mass index, said Dr. Istfan, the senior author in the study. However, Hispanic individuals were more likely to receive WLMs, he said.

Recognizing that “the ratio of weight regain to nadir weight is more indicative of overfeeding than other parameters,” Dr. Istfan said that he and his colleagues divided patients into quartiles of regain, based on this ratio. The quartiles fell out so that those who had the least regain either lost weight or regained less than 1.4%, to make up the first quartile. The second quartile included those who regained from 1.5% to 6.26%, while the third quartile ranged up to 14.29% regain. Those who regained 14.3% or more were in the highest quartile of weight regain.

In comparing characteristics of the quartiles, there were more African Americans in the two higher quartiles (P = .017). More patients had achieved maximal weight loss in the highest quartile of regain (P less than .0001), though preoperative BMI had also been higher in this group (P = .0008).

After statistical adjustment, the investigators found that for individuals who had the highest quartile of regain, patients who were adherent to their WLMs had significantly less weight regain than those who took no medication (P = .014). However, patients considered nonadherent saw no medication effect on weight regain. The differences were small overall, with adherent patients regaining about 27% of weight relative to their nadir and those who didn’t take WLMs regaining about 30%. These significant results were seen long after bariatric surgery, at about 7 years post surgery.

In another analysis that looked just at the quartile of patients with the highest regain rate, weight regain was significantly delayed among those who were prescribed – and were adherent to – WLMs (P = .023). The analysis used a threshold weight regain rate of 1.22% per month; levels lower than that did not see a significant drug effect, and the effect was not seen for those not adherent to their WLMs.

Finally, an adjusted statistical analysis compared those taking and not taking WLMs to see whether WLMs were effective at preventing weight regain in rolling 90-day intervals throughout the study period. Again, in the highest quartile, those who were adherent to WLMs had a lower odds ratio of hitting the 1.22%/month regain rate, compared with those not taking medication (OR, 0.570; 95% confidence interval, 0.371-0.877; P = .01). The effect was not significant for the nonadherent group (OR, 0.872; 95% CI, 0.593-1.284; P = .489).

As more bariatric procedures are being done, and as more patients are living with their surgeries, physicians are seeing more weight regain, said Dr. Istfan, noting that it’s important to assess efficacy of WLMs in the postsurgical population. “Recent work showed that by 5 years after gastric bypass, half of patients had regained more than 15% of their nadir weight, and two-thirds of patients had regained more than 20% of their total maximum weight loss, said Dr. Istfan (King WC et al. JAMA.2018;320:1560).

Typically, patients will see about a 35% weight loss at their nadir, with a gradual increase in weight gain beginning about 2 years after surgery. Though it’s true that a net weight loss of 25% is still good, it can be a misleading way to look at the data, “because it does not focus on the process of weight regain itself,” said Dr. Istfan.

“Despite the maintenance of substantial weight loss, weight regain is concerning: It’s the present and future, not the past,” he said.

Regaining weight necessarily means that patients are having excess nutrient intake and a net-positive energy balance; this state can be associated with oxidative stress, inflammation, and insulin resistance – all potential contributors to the recurrence of comorbidities.

What’s to be done about weight regain, if it’s a point of concern? One option, said Dr. Istfan, is to consider more surgery. Patients might want a “re-do;” techniques that have been tried include reshaping the pouch and doing an anastomosis plication. If a gastro-gastric fistula’s developed, that can be corrected, he said.

Some factors influencing regain can be targeted by behavioral therapy. These include addressing alcohol consumption, discouraging grazing, encouraging exercise, and assessing and modifying diet quality in general.

“There is a general reluctance on the part of physicians to use weight loss medications after bariatric surgery,” said Dr. Istfan. Reasons can include concern about further nutritional compromise, especially when thinking about long-term use of appetite-suppressing medications. Importantly, there aren’t clinical guidelines for prescribing WLMs after bariatric surgery, nor is there a strong body of prospective studies in this area.

Dr. Istfan noted that the medical and surgical bariatric teams collaborate closely at Boston Medical Center to provide pre- and postoperative assessment and management.

The long observational interval and ethnic and socioeconomic diversity of the study population are strengths, said Dr. Istfan. Also, the three different multivariable models converged to similar findings.

However, the study was retrospective, with some confounding likely, and each prescriber involved in the study may have varying prescribing practices. Also, adherence was assessed by follow-up medication appointments, a measure that likely introduced some inaccuracy.

“Weight loss medications are potentially effective tools to counter weight regain after bariatric surgery; prospective studies are needed to optimize the use of weight loss medications after bariatric surgery,” said Dr. Istfan.

Dr. Istfan reported no outside sources of funding, and no conflicts of interest.

AGA provides GIs with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at http://ow.ly/fFA330mWKCn.

SOURCE: Anderson W et al. Obesity Week 2018, Abstract T-OR-2016.

NASHVILLE – Is there a role for weight loss medications to help manage weight regain after bariatric surgery? Perhaps, according to a recent analysis of single-center clinical data.

Phentermine and topiramate were each prescribed to between 10% and 12.5% of bariatric surgery patients at Boston Medical Center in recent years. That figure had been steadily increasing since 2004, when data collection began, Nawfal W. Istfan, MD, PhD, said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

However, the center didn’t know how patients who had received medication fared for long-term maintenance of weight loss, compared with those who had surgery alone; also, there were no clinical guidelines for prescribing weight loss medications (WLMs). “Have we done those patients any benefit by prescribing weight loss medications after gastric bypass surgery?” asked Dr. Istfan. The answer from the Boston Medical Center data is a qualified “yes;” patients with the highest rates of weight regain who were adherent to their medication did see lower rates of regain, and fewer rapid weight regain events.

Comparing patients who received prescriptions with those who did not, patients with less weight loss at nadir were more likely to receive a prescription. “This could very well be the reason they were prescribed a medication: They did not lose as much weight, and they are more likely to ask us” for WLMs, said Dr. Istfan, an endocrinologist at Boston University. However, for those who were prescribed WLMs, the slope of regain was flatter than for those who didn’t receive medication. Of the 626 patients included in the study, 91 received phentermine alone, 54 topiramate alone, and 113 were prescribed both phentermine and topiramate. Three received lorcaserin.

Those receiving medication were similar to the total bariatric surgery population in terms of age, sex, comorbidities, socioeconomic status, and preoperative body mass index, said Dr. Istfan, the senior author in the study. However, Hispanic individuals were more likely to receive WLMs, he said.

Recognizing that “the ratio of weight regain to nadir weight is more indicative of overfeeding than other parameters,” Dr. Istfan said that he and his colleagues divided patients into quartiles of regain, based on this ratio. The quartiles fell out so that those who had the least regain either lost weight or regained less than 1.4%, to make up the first quartile. The second quartile included those who regained from 1.5% to 6.26%, while the third quartile ranged up to 14.29% regain. Those who regained 14.3% or more were in the highest quartile of weight regain.

In comparing characteristics of the quartiles, there were more African Americans in the two higher quartiles (P = .017). More patients had achieved maximal weight loss in the highest quartile of regain (P less than .0001), though preoperative BMI had also been higher in this group (P = .0008).

After statistical adjustment, the investigators found that for individuals who had the highest quartile of regain, patients who were adherent to their WLMs had significantly less weight regain than those who took no medication (P = .014). However, patients considered nonadherent saw no medication effect on weight regain. The differences were small overall, with adherent patients regaining about 27% of weight relative to their nadir and those who didn’t take WLMs regaining about 30%. These significant results were seen long after bariatric surgery, at about 7 years post surgery.

In another analysis that looked just at the quartile of patients with the highest regain rate, weight regain was significantly delayed among those who were prescribed – and were adherent to – WLMs (P = .023). The analysis used a threshold weight regain rate of 1.22% per month; levels lower than that did not see a significant drug effect, and the effect was not seen for those not adherent to their WLMs.

Finally, an adjusted statistical analysis compared those taking and not taking WLMs to see whether WLMs were effective at preventing weight regain in rolling 90-day intervals throughout the study period. Again, in the highest quartile, those who were adherent to WLMs had a lower odds ratio of hitting the 1.22%/month regain rate, compared with those not taking medication (OR, 0.570; 95% confidence interval, 0.371-0.877; P = .01). The effect was not significant for the nonadherent group (OR, 0.872; 95% CI, 0.593-1.284; P = .489).

As more bariatric procedures are being done, and as more patients are living with their surgeries, physicians are seeing more weight regain, said Dr. Istfan, noting that it’s important to assess efficacy of WLMs in the postsurgical population. “Recent work showed that by 5 years after gastric bypass, half of patients had regained more than 15% of their nadir weight, and two-thirds of patients had regained more than 20% of their total maximum weight loss, said Dr. Istfan (King WC et al. JAMA.2018;320:1560).

Typically, patients will see about a 35% weight loss at their nadir, with a gradual increase in weight gain beginning about 2 years after surgery. Though it’s true that a net weight loss of 25% is still good, it can be a misleading way to look at the data, “because it does not focus on the process of weight regain itself,” said Dr. Istfan.

“Despite the maintenance of substantial weight loss, weight regain is concerning: It’s the present and future, not the past,” he said.

Regaining weight necessarily means that patients are having excess nutrient intake and a net-positive energy balance; this state can be associated with oxidative stress, inflammation, and insulin resistance – all potential contributors to the recurrence of comorbidities.

What’s to be done about weight regain, if it’s a point of concern? One option, said Dr. Istfan, is to consider more surgery. Patients might want a “re-do;” techniques that have been tried include reshaping the pouch and doing an anastomosis plication. If a gastro-gastric fistula’s developed, that can be corrected, he said.

Some factors influencing regain can be targeted by behavioral therapy. These include addressing alcohol consumption, discouraging grazing, encouraging exercise, and assessing and modifying diet quality in general.

“There is a general reluctance on the part of physicians to use weight loss medications after bariatric surgery,” said Dr. Istfan. Reasons can include concern about further nutritional compromise, especially when thinking about long-term use of appetite-suppressing medications. Importantly, there aren’t clinical guidelines for prescribing WLMs after bariatric surgery, nor is there a strong body of prospective studies in this area.

Dr. Istfan noted that the medical and surgical bariatric teams collaborate closely at Boston Medical Center to provide pre- and postoperative assessment and management.

The long observational interval and ethnic and socioeconomic diversity of the study population are strengths, said Dr. Istfan. Also, the three different multivariable models converged to similar findings.

However, the study was retrospective, with some confounding likely, and each prescriber involved in the study may have varying prescribing practices. Also, adherence was assessed by follow-up medication appointments, a measure that likely introduced some inaccuracy.

“Weight loss medications are potentially effective tools to counter weight regain after bariatric surgery; prospective studies are needed to optimize the use of weight loss medications after bariatric surgery,” said Dr. Istfan.

Dr. Istfan reported no outside sources of funding, and no conflicts of interest.

AGA provides GIs with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at http://ow.ly/fFA330mWKCn.

SOURCE: Anderson W et al. Obesity Week 2018, Abstract T-OR-2016.