Video

PARIS – Beta-blocking drugs were as effective for improving survival in patients with moderately severe renal dysfunction as they were in patients with normal renal function in a meta-analysis of more than 13,000 patients, a finding that seemed to solidify the role for this drug class for essentially all similar heart failure patients, regardless of their renal function.

Mitchel L. Zoler/MDedge News

This evidence could reshape usual care because “renal impairment is often considered a barrier in clinical practice” for starting a beta-blocker drug in patients with heart failure with reduced ejection fraction (HFrEF), Dipak Kotecha, MBChB, said at the annual congress of the European Society of Cardiology.

“We have shown with sufficient sample size that beta-blockers are effective in reducing mortality in patient with HFrEF and in sinus rhythm, even in those with an eGFR [estimated glomerular filtration rate] of 30-44 mL/min per 1.73 m²,” said Dr. Kotecha, a cardiologist at the University of Birmingham (England). “The results suggest that renal impairment should not obstruct the prescription and maintenance of beta-blockers in patients with HFrEF.”

“This important study was a novel attempt to look at [HFrEF] patients with renal insufficiency to see whether they received the same benefit from beta-blockers as other patients, and they did. So renal insufficiency is not a reason to withhold beta-blockers” from these patients, commented Mariell Jessup, MD, a heart failure physician and chief science and medical officer for the American Heart Association in Dallas. “The onus is on clinicians to find a reason not to give a beta-blocker to a patient with HFrEF because they are generally well tolerated and they can have enormous benefit, as we saw in this study,” she said in a video interview.

The analysis run by Dr. Kotecha and associates used data collected in 11 of the pivotal randomized, controlled trial run for beta-blockers during the 1990s and early 2000s, with each study comparing bucindolol, bisoprolol, carvedilol, metoprolol XL, or nebivolol against placebo. The studies collectively enrolled 18,637 patients, which the investigators whittled down in their analysis to 17,433 after excluding patients with a left ventricular ejection fraction below 50% or who were undocumented. The subgroup with HFrEF included 13,861 patient in sinus rhythm at entry, 2,879 with atrial fibrillation, and 693 with an unknown atrial status. The main analysis ran in the 13,861 patients with HFrEF and in sinus rhythm; 14% of this cohort had an eGFR of 30-44 mL/min per 1.73 m² and 27% had an eGFR of 45-59 mL/min per 1.73 m². The median age of all patients in the main analysis was 65 years, 23% were women, and their median left ventricular ejection fraction was 27%.

During follow-up of about 3 years, the impact of beta-blocker treatment on survival, compared with placebo, was “substantial” for all strata of patients by renal function, except for those with eGFRs below 30 mL/min per 1.73 m². (Survival was similar regardless of beta-blocker treatment in the small number of patients with severe renal dysfunction.) The number needed to treat to prevent 1 death in patients with an eGFR of 30-44 mL/min per 1.73 m² was 21, the same as among patients with an eGFR of 90 mL/min per 1.73 m² or more, Dr. Kotecha said.

Among the subgroup of patients with atrial fibrillation, beta-blockers appeared to exert no survival benefit, compared with placebo. The investigators did not assess the survival benefits exerted by any individual beta-blocker, compared with the others, and Dr. Kotecha stressed that “my belief is that this is a class effect” and is roughly similar across all the beta-blockers used in the studies.

The analysis also showed good safety and tolerability of the beta-blockers in patients with renal dysfunction. The incidence of adverse events leading to treatment termination was very similar in the beta-blocker and placebo arms, and more than three-quarters of patients in each of the two subgroups with renal dysfunction were maintained on more than 50% of their target beta-blocker dosage.

Dr. Kotecha has been an advisor to Bayer, a speaker on behalf of Atricure, and has received research funding from GlaxoSmithKline and Menarini. Dr. Jessup had no disclosures.

[email protected]

PARIS – Beta-blocking drugs were as effective for improving survival in patients with moderately severe renal dysfunction as they were in patients with normal renal function in a meta-analysis of more than 13,000 patients, a finding that seemed to solidify the role for this drug class for essentially all similar heart failure patients, regardless of their renal function.

Mitchel L. Zoler/MDedge News

This evidence could reshape usual care because “renal impairment is often considered a barrier in clinical practice” for starting a beta-blocker drug in patients with heart failure with reduced ejection fraction (HFrEF), Dipak Kotecha, MBChB, said at the annual congress of the European Society of Cardiology.

“We have shown with sufficient sample size that beta-blockers are effective in reducing mortality in patient with HFrEF and in sinus rhythm, even in those with an eGFR [estimated glomerular filtration rate] of 30-44 mL/min per 1.73 m²,” said Dr. Kotecha, a cardiologist at the University of Birmingham (England). “The results suggest that renal impairment should not obstruct the prescription and maintenance of beta-blockers in patients with HFrEF.”

“This important study was a novel attempt to look at [HFrEF] patients with renal insufficiency to see whether they received the same benefit from beta-blockers as other patients, and they did. So renal insufficiency is not a reason to withhold beta-blockers” from these patients, commented Mariell Jessup, MD, a heart failure physician and chief science and medical officer for the American Heart Association in Dallas. “The onus is on clinicians to find a reason not to give a beta-blocker to a patient with HFrEF because they are generally well tolerated and they can have enormous benefit, as we saw in this study,” she said in a video interview.

The analysis run by Dr. Kotecha and associates used data collected in 11 of the pivotal randomized, controlled trial run for beta-blockers during the 1990s and early 2000s, with each study comparing bucindolol, bisoprolol, carvedilol, metoprolol XL, or nebivolol against placebo. The studies collectively enrolled 18,637 patients, which the investigators whittled down in their analysis to 17,433 after excluding patients with a left ventricular ejection fraction below 50% or who were undocumented. The subgroup with HFrEF included 13,861 patient in sinus rhythm at entry, 2,879 with atrial fibrillation, and 693 with an unknown atrial status. The main analysis ran in the 13,861 patients with HFrEF and in sinus rhythm; 14% of this cohort had an eGFR of 30-44 mL/min per 1.73 m² and 27% had an eGFR of 45-59 mL/min per 1.73 m². The median age of all patients in the main analysis was 65 years, 23% were women, and their median left ventricular ejection fraction was 27%.

During follow-up of about 3 years, the impact of beta-blocker treatment on survival, compared with placebo, was “substantial” for all strata of patients by renal function, except for those with eGFRs below 30 mL/min per 1.73 m². (Survival was similar regardless of beta-blocker treatment in the small number of patients with severe renal dysfunction.) The number needed to treat to prevent 1 death in patients with an eGFR of 30-44 mL/min per 1.73 m² was 21, the same as among patients with an eGFR of 90 mL/min per 1.73 m² or more, Dr. Kotecha said.

Among the subgroup of patients with atrial fibrillation, beta-blockers appeared to exert no survival benefit, compared with placebo. The investigators did not assess the survival benefits exerted by any individual beta-blocker, compared with the others, and Dr. Kotecha stressed that “my belief is that this is a class effect” and is roughly similar across all the beta-blockers used in the studies.

The analysis also showed good safety and tolerability of the beta-blockers in patients with renal dysfunction. The incidence of adverse events leading to treatment termination was very similar in the beta-blocker and placebo arms, and more than three-quarters of patients in each of the two subgroups with renal dysfunction were maintained on more than 50% of their target beta-blocker dosage.

Dr. Kotecha has been an advisor to Bayer, a speaker on behalf of Atricure, and has received research funding from GlaxoSmithKline and Menarini. Dr. Jessup had no disclosures.

[email protected]

PARIS – Beta-blocking drugs were as effective for improving survival in patients with moderately severe renal dysfunction as they were in patients with normal renal function in a meta-analysis of more than 13,000 patients, a finding that seemed to solidify the role for this drug class for essentially all similar heart failure patients, regardless of their renal function.

Mitchel L. Zoler/MDedge News

This evidence could reshape usual care because “renal impairment is often considered a barrier in clinical practice” for starting a beta-blocker drug in patients with heart failure with reduced ejection fraction (HFrEF), Dipak Kotecha, MBChB, said at the annual congress of the European Society of Cardiology.

“We have shown with sufficient sample size that beta-blockers are effective in reducing mortality in patient with HFrEF and in sinus rhythm, even in those with an eGFR [estimated glomerular filtration rate] of 30-44 mL/min per 1.73 m²,” said Dr. Kotecha, a cardiologist at the University of Birmingham (England). “The results suggest that renal impairment should not obstruct the prescription and maintenance of beta-blockers in patients with HFrEF.”

“This important study was a novel attempt to look at [HFrEF] patients with renal insufficiency to see whether they received the same benefit from beta-blockers as other patients, and they did. So renal insufficiency is not a reason to withhold beta-blockers” from these patients, commented Mariell Jessup, MD, a heart failure physician and chief science and medical officer for the American Heart Association in Dallas. “The onus is on clinicians to find a reason not to give a beta-blocker to a patient with HFrEF because they are generally well tolerated and they can have enormous benefit, as we saw in this study,” she said in a video interview.

The analysis run by Dr. Kotecha and associates used data collected in 11 of the pivotal randomized, controlled trial run for beta-blockers during the 1990s and early 2000s, with each study comparing bucindolol, bisoprolol, carvedilol, metoprolol XL, or nebivolol against placebo. The studies collectively enrolled 18,637 patients, which the investigators whittled down in their analysis to 17,433 after excluding patients with a left ventricular ejection fraction below 50% or who were undocumented. The subgroup with HFrEF included 13,861 patient in sinus rhythm at entry, 2,879 with atrial fibrillation, and 693 with an unknown atrial status. The main analysis ran in the 13,861 patients with HFrEF and in sinus rhythm; 14% of this cohort had an eGFR of 30-44 mL/min per 1.73 m² and 27% had an eGFR of 45-59 mL/min per 1.73 m². The median age of all patients in the main analysis was 65 years, 23% were women, and their median left ventricular ejection fraction was 27%.

During follow-up of about 3 years, the impact of beta-blocker treatment on survival, compared with placebo, was “substantial” for all strata of patients by renal function, except for those with eGFRs below 30 mL/min per 1.73 m². (Survival was similar regardless of beta-blocker treatment in the small number of patients with severe renal dysfunction.) The number needed to treat to prevent 1 death in patients with an eGFR of 30-44 mL/min per 1.73 m² was 21, the same as among patients with an eGFR of 90 mL/min per 1.73 m² or more, Dr. Kotecha said.

Among the subgroup of patients with atrial fibrillation, beta-blockers appeared to exert no survival benefit, compared with placebo. The investigators did not assess the survival benefits exerted by any individual beta-blocker, compared with the others, and Dr. Kotecha stressed that “my belief is that this is a class effect” and is roughly similar across all the beta-blockers used in the studies.

The analysis also showed good safety and tolerability of the beta-blockers in patients with renal dysfunction. The incidence of adverse events leading to treatment termination was very similar in the beta-blocker and placebo arms, and more than three-quarters of patients in each of the two subgroups with renal dysfunction were maintained on more than 50% of their target beta-blocker dosage.

Dr. Kotecha has been an advisor to Bayer, a speaker on behalf of Atricure, and has received research funding from GlaxoSmithKline and Menarini. Dr. Jessup had no disclosures.

[email protected]

Can receiving all posttransplant care at home benefit patients undergoing hematopoietic stem cell transplant (HSCT)? Researchers are conducting phase 2 trials to find out.

Nelson Chao, MD, and colleagues at Duke University in Durham, N.C., completed a phase 1 trial that suggested post-HSCT care at home was feasible and safe (Blood. 2017;130:745).

Now, the team is conducting phase 2 trials – NCT01725022 and NCT02218151 – comparing patients who receive all posttransplant care at home with patients treated in the hospital or in the outpatient setting with daily visits to the clinic.

The main goal is to determine if allogeneic HSCT recipients treated at home can maintain their normal microbiome and, as a result, have a lower risk of graft-versus-host disease (GVHD). The researchers are also looking at other outcomes such as quality of life, treatment-related morbidities and mortality, and the cost of care for both allogeneic and autologous transplant recipients.

To be eligible for home care after HSCT, a patient must live within a 90-minute driving distance of Duke and have a caregiver available at home. The patient’s home must pass an inspection, showing it to be free of sources for potential infection, such as mold or pets that sleep in the patient’s bed.

When the time comes for treatment, the patient receives conditioning at the hospital but can return home the day before or the day of transplant. After discharge, the patient is visited by a nurse practitioner or physician assistant each morning for a physical examination and blood draw.

In the afternoon, the patient is visited by a clinic nurse who brings any necessary supplies or treatments, such as blood products or intravenous antibiotics. The patient also has daily video calls with an attending physician and can be admitted to the hospital for any events that cannot be managed in the home setting.

Patients can have visitors and spend time away from home, but precautions are necessary. Friends or family who are sick should not be allowed to visit, and patients should avoid crowds when they go out.

Vidyard Video

Initial findings

The Duke team has treated 41 HSCT recipients at home so far. Dr. Chao said it’s still too early to draw any conclusions about differences in outcomes between home care and inpatient/outpatient HSCT.

However, a preliminary analysis of costs suggests home care is cheaper than inpatient HSCT. The researchers found that, for the first several transplants, at day 60, the cost of home care was roughly half that of inpatient HSCT.

In addition, patients seem to be happy with posttransplant care at home.

“The patients love being at home, in their own environment, with their families,” Dr. Chao said. “Almost every single patient [in the phase 1 trial] said that he or she liked it much better. There was one patient in the phase 1 that felt a little isolated, and I can see why because we say, ‘You can stay home, but don’t have a whole lot of people in.’ ”

 

 

One patient’s experience

Beth Vanderkin said it was “a blessing” to receive care at home after undergoing HSCT at Duke.

Ms. Vanderkin was diagnosed with diffuse large B-cell lymphoma in 2014. After two chemotherapy regimens failed to shrink the tumor in her chest, she underwent radiotherapy and responded well. When a PET scan revealed the tumor had gone completely, she proceeded to transplant.

She received a haploidentical HSCT using cells donated by her eldest daughter, Hannah Eichhorst. Ms. Vanderkin received the transplant in the hospital, and for 2 weeks after that, she made daily visits to the transplant clinic.

After those 2 weeks, Ms. Vanderkin continued her treatment at home. Like other patients eligible for home care, Ms. Vanderkin lived close to Duke, had a caregiver available, and had passed a home inspection. The Duke team shipped the needed medical supplies to her house and arranged twice-daily visits from nurses and daily video calls with a doctor.

Ms. Vanderkin said receiving care at home was “a game changer.” She derived comfort from recovering in her own environment, could spend more time with her family, and didn’t have to miss special events. While receiving care at home, Ms. Vanderkin attended the homecoming event where her son, Josiah, was part of the court. Wearing a face mask and carrying a portable pump in her purse, Ms. Vanderkin joined other mothers in escorting their children onto the football field.

“I got to escort my son out onto the field, and he was crowned king that night,” Ms. Vanderkin said. “I didn’t do a lot of things [while receiving care at home], but there were things I didn’t have to miss because I was at home and not in the hospital.”

Ms. Vanderkin said home care was also beneficial for her husband, who was her caregiver. Thomas Vanderkin was able to work from home while caring for his wife, and the daily nurses’ visits allowed him to run errands without having to leave Ms. Vanderkin alone.

Since her experience with home care, Ms. Vanderkin has spent many more days in the hospital and clinic. She experienced a relapse after the transplant and went on to receive more chemotherapy as well as ipilimumab. She responded to that treatment and has now been cancer-free for 3 years.

The ipilimumab did cause side effects, including intestinal problems that resulted in the need for parenteral nutrition. This side effect was made more bearable, Ms. Vanderkin said, because she was able to receive the parenteral nutrition at home. She and her husband were comfortable with additional home care because of their positive experience with posttransplant care.

“I think we’re conditioned to think that, to receive the best care, we have to be sitting in a hospital room or a clinic, but I think there’s a lot of things we can probably do at home,” Ms. Vanderkin said. “And we might fare a lot better as patients if we’re in an environment that we feel comfortable in.”

 

 

Experience at other centers

The team at Duke is not the first to study HSCT care at home. In fact, researchers in Sweden have been studying posttransplant home care since 1998.

A pilot trial the group published in 2000 suggested that home care was safe and, in some ways, superior to inpatient HSCT (Bone Marrow Transplant. 2000 Nov;26[10]:1057-60). Patients treated at home had a lower rate of bacteremia, fewer days of total parenteral nutrition, fewer erythrocyte transfusions, and fewer days on antibiotics and analgesics. Rates of fever, engraftment time, and acute GVHD were similar between the inpatient and home-care groups.

A study published by the same researchers in 2002 showed that patients who received home care had lower rates of grade 2-4 acute GVHD and transplant-related mortality compared to inpatients (Blood. 2002 Dec 15;100[13]:4317-24). Two-year overall survival was superior with home care as well.

On the other hand, a study the group published in 2013 showed no significant differences in 5-year survival, transplant-related mortality, relapse, or chronic GVHD between inpatients and those who received care at home (Biol Blood Marrow Transplant. 2013. doi: 10.1016/j.bbmt.2012.11.5189).

The phase 2 trials at Duke should provide more insight into patient outcomes, but results probably won’t be available for 2 more years, Dr. Chao said.

In the meantime, other U.S. researchers are studying home care as well. Memorial Sloan Kettering Cancer Center is conducting a pilot study to determine if HSCT care at home is feasible (NCT02671448).

Dr. Chao said home care should be possible for other centers, particularly those that already perform outpatient HSCT.

“Having the outpatient infrastructure to support these patients is a big step,” he said. “And I think we were able to do that mainly because we do most of our transplants in the outpatient setting already. So that jump to the home is a little less compared to a center that does no outpatient transplants.”

He added, “There’s a certain amount of inertia to overcome and a certain amount of apprehension from the caregivers initially because [patients aren’t] sitting in your unit all the time, but I don’t see this as a huge barrier.”

In fact, Dr. Chao said, if results with home care are favorable, it could potentially replace inpatient HSCT for certain patients.

Dr. Chao’s research is supported by Duke University, and he reported having no relevant financial disclosures.

[email protected]

Can receiving all posttransplant care at home benefit patients undergoing hematopoietic stem cell transplant (HSCT)? Researchers are conducting phase 2 trials to find out.

Nelson Chao, MD, and colleagues at Duke University in Durham, N.C., completed a phase 1 trial that suggested post-HSCT care at home was feasible and safe (Blood. 2017;130:745).

Now, the team is conducting phase 2 trials – NCT01725022 and NCT02218151 – comparing patients who receive all posttransplant care at home with patients treated in the hospital or in the outpatient setting with daily visits to the clinic.

The main goal is to determine if allogeneic HSCT recipients treated at home can maintain their normal microbiome and, as a result, have a lower risk of graft-versus-host disease (GVHD). The researchers are also looking at other outcomes such as quality of life, treatment-related morbidities and mortality, and the cost of care for both allogeneic and autologous transplant recipients.

To be eligible for home care after HSCT, a patient must live within a 90-minute driving distance of Duke and have a caregiver available at home. The patient’s home must pass an inspection, showing it to be free of sources for potential infection, such as mold or pets that sleep in the patient’s bed.

When the time comes for treatment, the patient receives conditioning at the hospital but can return home the day before or the day of transplant. After discharge, the patient is visited by a nurse practitioner or physician assistant each morning for a physical examination and blood draw.

In the afternoon, the patient is visited by a clinic nurse who brings any necessary supplies or treatments, such as blood products or intravenous antibiotics. The patient also has daily video calls with an attending physician and can be admitted to the hospital for any events that cannot be managed in the home setting.

Patients can have visitors and spend time away from home, but precautions are necessary. Friends or family who are sick should not be allowed to visit, and patients should avoid crowds when they go out.

Vidyard Video

Initial findings

The Duke team has treated 41 HSCT recipients at home so far. Dr. Chao said it’s still too early to draw any conclusions about differences in outcomes between home care and inpatient/outpatient HSCT.

However, a preliminary analysis of costs suggests home care is cheaper than inpatient HSCT. The researchers found that, for the first several transplants, at day 60, the cost of home care was roughly half that of inpatient HSCT.

In addition, patients seem to be happy with posttransplant care at home.

“The patients love being at home, in their own environment, with their families,” Dr. Chao said. “Almost every single patient [in the phase 1 trial] said that he or she liked it much better. There was one patient in the phase 1 that felt a little isolated, and I can see why because we say, ‘You can stay home, but don’t have a whole lot of people in.’ ”

 

 

One patient’s experience

Beth Vanderkin said it was “a blessing” to receive care at home after undergoing HSCT at Duke.

Ms. Vanderkin was diagnosed with diffuse large B-cell lymphoma in 2014. After two chemotherapy regimens failed to shrink the tumor in her chest, she underwent radiotherapy and responded well. When a PET scan revealed the tumor had gone completely, she proceeded to transplant.

She received a haploidentical HSCT using cells donated by her eldest daughter, Hannah Eichhorst. Ms. Vanderkin received the transplant in the hospital, and for 2 weeks after that, she made daily visits to the transplant clinic.

After those 2 weeks, Ms. Vanderkin continued her treatment at home. Like other patients eligible for home care, Ms. Vanderkin lived close to Duke, had a caregiver available, and had passed a home inspection. The Duke team shipped the needed medical supplies to her house and arranged twice-daily visits from nurses and daily video calls with a doctor.

Ms. Vanderkin said receiving care at home was “a game changer.” She derived comfort from recovering in her own environment, could spend more time with her family, and didn’t have to miss special events. While receiving care at home, Ms. Vanderkin attended the homecoming event where her son, Josiah, was part of the court. Wearing a face mask and carrying a portable pump in her purse, Ms. Vanderkin joined other mothers in escorting their children onto the football field.

“I got to escort my son out onto the field, and he was crowned king that night,” Ms. Vanderkin said. “I didn’t do a lot of things [while receiving care at home], but there were things I didn’t have to miss because I was at home and not in the hospital.”

Ms. Vanderkin said home care was also beneficial for her husband, who was her caregiver. Thomas Vanderkin was able to work from home while caring for his wife, and the daily nurses’ visits allowed him to run errands without having to leave Ms. Vanderkin alone.

Since her experience with home care, Ms. Vanderkin has spent many more days in the hospital and clinic. She experienced a relapse after the transplant and went on to receive more chemotherapy as well as ipilimumab. She responded to that treatment and has now been cancer-free for 3 years.

The ipilimumab did cause side effects, including intestinal problems that resulted in the need for parenteral nutrition. This side effect was made more bearable, Ms. Vanderkin said, because she was able to receive the parenteral nutrition at home. She and her husband were comfortable with additional home care because of their positive experience with posttransplant care.

“I think we’re conditioned to think that, to receive the best care, we have to be sitting in a hospital room or a clinic, but I think there’s a lot of things we can probably do at home,” Ms. Vanderkin said. “And we might fare a lot better as patients if we’re in an environment that we feel comfortable in.”

 

 

Experience at other centers

The team at Duke is not the first to study HSCT care at home. In fact, researchers in Sweden have been studying posttransplant home care since 1998.

A pilot trial the group published in 2000 suggested that home care was safe and, in some ways, superior to inpatient HSCT (Bone Marrow Transplant. 2000 Nov;26[10]:1057-60). Patients treated at home had a lower rate of bacteremia, fewer days of total parenteral nutrition, fewer erythrocyte transfusions, and fewer days on antibiotics and analgesics. Rates of fever, engraftment time, and acute GVHD were similar between the inpatient and home-care groups.

A study published by the same researchers in 2002 showed that patients who received home care had lower rates of grade 2-4 acute GVHD and transplant-related mortality compared to inpatients (Blood. 2002 Dec 15;100[13]:4317-24). Two-year overall survival was superior with home care as well.

On the other hand, a study the group published in 2013 showed no significant differences in 5-year survival, transplant-related mortality, relapse, or chronic GVHD between inpatients and those who received care at home (Biol Blood Marrow Transplant. 2013. doi: 10.1016/j.bbmt.2012.11.5189).

The phase 2 trials at Duke should provide more insight into patient outcomes, but results probably won’t be available for 2 more years, Dr. Chao said.

In the meantime, other U.S. researchers are studying home care as well. Memorial Sloan Kettering Cancer Center is conducting a pilot study to determine if HSCT care at home is feasible (NCT02671448).

Dr. Chao said home care should be possible for other centers, particularly those that already perform outpatient HSCT.

“Having the outpatient infrastructure to support these patients is a big step,” he said. “And I think we were able to do that mainly because we do most of our transplants in the outpatient setting already. So that jump to the home is a little less compared to a center that does no outpatient transplants.”

He added, “There’s a certain amount of inertia to overcome and a certain amount of apprehension from the caregivers initially because [patients aren’t] sitting in your unit all the time, but I don’t see this as a huge barrier.”

In fact, Dr. Chao said, if results with home care are favorable, it could potentially replace inpatient HSCT for certain patients.

Dr. Chao’s research is supported by Duke University, and he reported having no relevant financial disclosures.

[email protected]

Can receiving all posttransplant care at home benefit patients undergoing hematopoietic stem cell transplant (HSCT)? Researchers are conducting phase 2 trials to find out.

Nelson Chao, MD, and colleagues at Duke University in Durham, N.C., completed a phase 1 trial that suggested post-HSCT care at home was feasible and safe (Blood. 2017;130:745).

Now, the team is conducting phase 2 trials – NCT01725022 and NCT02218151 – comparing patients who receive all posttransplant care at home with patients treated in the hospital or in the outpatient setting with daily visits to the clinic.

The main goal is to determine if allogeneic HSCT recipients treated at home can maintain their normal microbiome and, as a result, have a lower risk of graft-versus-host disease (GVHD). The researchers are also looking at other outcomes such as quality of life, treatment-related morbidities and mortality, and the cost of care for both allogeneic and autologous transplant recipients.

To be eligible for home care after HSCT, a patient must live within a 90-minute driving distance of Duke and have a caregiver available at home. The patient’s home must pass an inspection, showing it to be free of sources for potential infection, such as mold or pets that sleep in the patient’s bed.

When the time comes for treatment, the patient receives conditioning at the hospital but can return home the day before or the day of transplant. After discharge, the patient is visited by a nurse practitioner or physician assistant each morning for a physical examination and blood draw.

In the afternoon, the patient is visited by a clinic nurse who brings any necessary supplies or treatments, such as blood products or intravenous antibiotics. The patient also has daily video calls with an attending physician and can be admitted to the hospital for any events that cannot be managed in the home setting.

Patients can have visitors and spend time away from home, but precautions are necessary. Friends or family who are sick should not be allowed to visit, and patients should avoid crowds when they go out.

Vidyard Video

Initial findings

The Duke team has treated 41 HSCT recipients at home so far. Dr. Chao said it’s still too early to draw any conclusions about differences in outcomes between home care and inpatient/outpatient HSCT.

However, a preliminary analysis of costs suggests home care is cheaper than inpatient HSCT. The researchers found that, for the first several transplants, at day 60, the cost of home care was roughly half that of inpatient HSCT.

In addition, patients seem to be happy with posttransplant care at home.

“The patients love being at home, in their own environment, with their families,” Dr. Chao said. “Almost every single patient [in the phase 1 trial] said that he or she liked it much better. There was one patient in the phase 1 that felt a little isolated, and I can see why because we say, ‘You can stay home, but don’t have a whole lot of people in.’ ”

 

 

One patient’s experience

Beth Vanderkin said it was “a blessing” to receive care at home after undergoing HSCT at Duke.

Ms. Vanderkin was diagnosed with diffuse large B-cell lymphoma in 2014. After two chemotherapy regimens failed to shrink the tumor in her chest, she underwent radiotherapy and responded well. When a PET scan revealed the tumor had gone completely, she proceeded to transplant.

She received a haploidentical HSCT using cells donated by her eldest daughter, Hannah Eichhorst. Ms. Vanderkin received the transplant in the hospital, and for 2 weeks after that, she made daily visits to the transplant clinic.

After those 2 weeks, Ms. Vanderkin continued her treatment at home. Like other patients eligible for home care, Ms. Vanderkin lived close to Duke, had a caregiver available, and had passed a home inspection. The Duke team shipped the needed medical supplies to her house and arranged twice-daily visits from nurses and daily video calls with a doctor.

Ms. Vanderkin said receiving care at home was “a game changer.” She derived comfort from recovering in her own environment, could spend more time with her family, and didn’t have to miss special events. While receiving care at home, Ms. Vanderkin attended the homecoming event where her son, Josiah, was part of the court. Wearing a face mask and carrying a portable pump in her purse, Ms. Vanderkin joined other mothers in escorting their children onto the football field.

“I got to escort my son out onto the field, and he was crowned king that night,” Ms. Vanderkin said. “I didn’t do a lot of things [while receiving care at home], but there were things I didn’t have to miss because I was at home and not in the hospital.”

Ms. Vanderkin said home care was also beneficial for her husband, who was her caregiver. Thomas Vanderkin was able to work from home while caring for his wife, and the daily nurses’ visits allowed him to run errands without having to leave Ms. Vanderkin alone.

Since her experience with home care, Ms. Vanderkin has spent many more days in the hospital and clinic. She experienced a relapse after the transplant and went on to receive more chemotherapy as well as ipilimumab. She responded to that treatment and has now been cancer-free for 3 years.

The ipilimumab did cause side effects, including intestinal problems that resulted in the need for parenteral nutrition. This side effect was made more bearable, Ms. Vanderkin said, because she was able to receive the parenteral nutrition at home. She and her husband were comfortable with additional home care because of their positive experience with posttransplant care.

“I think we’re conditioned to think that, to receive the best care, we have to be sitting in a hospital room or a clinic, but I think there’s a lot of things we can probably do at home,” Ms. Vanderkin said. “And we might fare a lot better as patients if we’re in an environment that we feel comfortable in.”

 

 

Experience at other centers

The team at Duke is not the first to study HSCT care at home. In fact, researchers in Sweden have been studying posttransplant home care since 1998.

A pilot trial the group published in 2000 suggested that home care was safe and, in some ways, superior to inpatient HSCT (Bone Marrow Transplant. 2000 Nov;26[10]:1057-60). Patients treated at home had a lower rate of bacteremia, fewer days of total parenteral nutrition, fewer erythrocyte transfusions, and fewer days on antibiotics and analgesics. Rates of fever, engraftment time, and acute GVHD were similar between the inpatient and home-care groups.

A study published by the same researchers in 2002 showed that patients who received home care had lower rates of grade 2-4 acute GVHD and transplant-related mortality compared to inpatients (Blood. 2002 Dec 15;100[13]:4317-24). Two-year overall survival was superior with home care as well.

On the other hand, a study the group published in 2013 showed no significant differences in 5-year survival, transplant-related mortality, relapse, or chronic GVHD between inpatients and those who received care at home (Biol Blood Marrow Transplant. 2013. doi: 10.1016/j.bbmt.2012.11.5189).

The phase 2 trials at Duke should provide more insight into patient outcomes, but results probably won’t be available for 2 more years, Dr. Chao said.

In the meantime, other U.S. researchers are studying home care as well. Memorial Sloan Kettering Cancer Center is conducting a pilot study to determine if HSCT care at home is feasible (NCT02671448).

Dr. Chao said home care should be possible for other centers, particularly those that already perform outpatient HSCT.

“Having the outpatient infrastructure to support these patients is a big step,” he said. “And I think we were able to do that mainly because we do most of our transplants in the outpatient setting already. So that jump to the home is a little less compared to a center that does no outpatient transplants.”

He added, “There’s a certain amount of inertia to overcome and a certain amount of apprehension from the caregivers initially because [patients aren’t] sitting in your unit all the time, but I don’t see this as a huge barrier.”

In fact, Dr. Chao said, if results with home care are favorable, it could potentially replace inpatient HSCT for certain patients.

Dr. Chao’s research is supported by Duke University, and he reported having no relevant financial disclosures.

[email protected]

PARIS – Middle-aged adults with a body mass index of 25-29 kg/m² had a significantly better adjusted survival during a median follow-up of nearly 10 years than did people with a “normal” body mass index of 20-24 kg/m² in a worldwide study of more than 140,000. This finding suggests the current, widely accepted definition of normal body mass index is wrong.*

Mitchel L. Zoler/MDedge News

The new findings suggest that the current definition of a “healthy” body mass index (BMI) “should be re-evaluated,” Darryl P. Leong, MBBS, said at the annual Congress of the European Society of Cardiology. The analysis also identified a BMI specifically of 27 kg/m² as associated with optimal survival among both women and men, “clearly outside the range of 20 to less than 25 kg/m² that is considered normal,” said Dr. Leong, a cardiologist at McMaster University and the Population Health Research Institute, both in Hamilton, Ont.

Dr. Leong cited three potential explanations for why the new study identified optimal survival with a BMI of 25 to less than 30 kg/m² among people who were 35-70 years old when they entered the study and were followed for a median of 9.5 years: The current study collected data and adjusted the results using a wider range of potential confounders than in prior studies, the data reflect the impact of contemporary interventions to reduce cardiovascular disease illness and death while past studies relied on data from earlier times when less cardiovascular disease protection occurred, and the current study included people from lower-income countries, although the finding is just as applicable to people who live in high-income countries, who were also included in the study population, noted Salim Yusuf, MBBS, principal investigator for the study.

A BMI of 20-24 kg/m² “is actually low and harmful,” noted Dr. Yusuf in an interview. Despite recent data consistently showing better survival among people with a BMI of 25-29 kg/m², panels that have recently written weight guidelines are “ossified” and “refuse to accept” the implications of these findings, said Dr. Yusuf, professor of medicine at McMaster and executive director of the Population Health Research Institute.

The results of the analyses that Dr. Leong reported also showed that BMI paled as a prognosticator for survival when compared with two other assessments of weight: waist/hip ratio, and even more powerful prognostically, a novel measure developed for this analysis that calculates the ratio of hand-grip strength/body weight. Waist/hip ratio adds the dimension of the location of body fat rather than just the amount, and the ratio of grip strength/body weight assesses the contribution of muscle mass to overall weight, noted Dr. Leong. He reported an optimal waist/hip ratio for survival of 0.83 in women and 0.93 in men, and an optimal strength/weight ratio of 0.42 in women and 0.50 in men. This means that a man whose hand-grip strength (measured in kg) is half of the person’s body weight has the best prospect for survival.
 
The study used data collected in PURE (Prospective Urban Rural Epidemiology Study) on 142,410 people aged 35-70 years from any one of four high-income countries, 12 middle-income countries, and five low-income countries. The study excluded people who had at baseline known coronary artery disease, stroke, heart failure, or cancer, and the adjusted analysis controlled for age, sex, region, education, activity, alcohol and tobacco use, and the baseline prevalence of hypertension and diabetes. During follow-up, 9,712 of these people died.

The researchers saw a nadir for mortality among people with a BMI of 25-29 kg/m² for both cardiovascular and noncardiovascular deaths. In addition, the link between total mortality and BMI was strongest in the subgroup of people on one or more treatments aimed at preventing cardiovascular disease, while it essentially disappeared among people not receiving any cardiovascular disease preventive measures, highlighting that the relationship now identified depends on a context of overall cardiovascular disease risk reduction, Dr. Leong said. The results also showed a very clear, direct, linear relationship between higher BMI and both the incidence of diabetes and cardiovascular disease, as well as increased all-cause and noncardiovascular mortality among people with a BMI of less than 20 kg/m².

Dr. Yusuf discussed the results of the analysis in a video interview.

The PURE study has received partial funding from unrestricted grants from several drug companies. Dr. Leong has been an advisor to Ferring Pharmaceuticals and has been a speaker on behalf of Janssen. Dr. Yusuf had no disclosures.

[email protected]

This story was updated 9/19/2019.

PARIS – Middle-aged adults with a body mass index of 25-29 kg/m² had a significantly better adjusted survival during a median follow-up of nearly 10 years than did people with a “normal” body mass index of 20-24 kg/m² in a worldwide study of more than 140,000. This finding suggests the current, widely accepted definition of normal body mass index is wrong.*

Mitchel L. Zoler/MDedge News

The new findings suggest that the current definition of a “healthy” body mass index (BMI) “should be re-evaluated,” Darryl P. Leong, MBBS, said at the annual Congress of the European Society of Cardiology. The analysis also identified a BMI specifically of 27 kg/m² as associated with optimal survival among both women and men, “clearly outside the range of 20 to less than 25 kg/m² that is considered normal,” said Dr. Leong, a cardiologist at McMaster University and the Population Health Research Institute, both in Hamilton, Ont.

Dr. Leong cited three potential explanations for why the new study identified optimal survival with a BMI of 25 to less than 30 kg/m² among people who were 35-70 years old when they entered the study and were followed for a median of 9.5 years: The current study collected data and adjusted the results using a wider range of potential confounders than in prior studies, the data reflect the impact of contemporary interventions to reduce cardiovascular disease illness and death while past studies relied on data from earlier times when less cardiovascular disease protection occurred, and the current study included people from lower-income countries, although the finding is just as applicable to people who live in high-income countries, who were also included in the study population, noted Salim Yusuf, MBBS, principal investigator for the study.

A BMI of 20-24 kg/m² “is actually low and harmful,” noted Dr. Yusuf in an interview. Despite recent data consistently showing better survival among people with a BMI of 25-29 kg/m², panels that have recently written weight guidelines are “ossified” and “refuse to accept” the implications of these findings, said Dr. Yusuf, professor of medicine at McMaster and executive director of the Population Health Research Institute.

The results of the analyses that Dr. Leong reported also showed that BMI paled as a prognosticator for survival when compared with two other assessments of weight: waist/hip ratio, and even more powerful prognostically, a novel measure developed for this analysis that calculates the ratio of hand-grip strength/body weight. Waist/hip ratio adds the dimension of the location of body fat rather than just the amount, and the ratio of grip strength/body weight assesses the contribution of muscle mass to overall weight, noted Dr. Leong. He reported an optimal waist/hip ratio for survival of 0.83 in women and 0.93 in men, and an optimal strength/weight ratio of 0.42 in women and 0.50 in men. This means that a man whose hand-grip strength (measured in kg) is half of the person’s body weight has the best prospect for survival.
 
The study used data collected in PURE (Prospective Urban Rural Epidemiology Study) on 142,410 people aged 35-70 years from any one of four high-income countries, 12 middle-income countries, and five low-income countries. The study excluded people who had at baseline known coronary artery disease, stroke, heart failure, or cancer, and the adjusted analysis controlled for age, sex, region, education, activity, alcohol and tobacco use, and the baseline prevalence of hypertension and diabetes. During follow-up, 9,712 of these people died.

The researchers saw a nadir for mortality among people with a BMI of 25-29 kg/m² for both cardiovascular and noncardiovascular deaths. In addition, the link between total mortality and BMI was strongest in the subgroup of people on one or more treatments aimed at preventing cardiovascular disease, while it essentially disappeared among people not receiving any cardiovascular disease preventive measures, highlighting that the relationship now identified depends on a context of overall cardiovascular disease risk reduction, Dr. Leong said. The results also showed a very clear, direct, linear relationship between higher BMI and both the incidence of diabetes and cardiovascular disease, as well as increased all-cause and noncardiovascular mortality among people with a BMI of less than 20 kg/m².

Dr. Yusuf discussed the results of the analysis in a video interview.

The PURE study has received partial funding from unrestricted grants from several drug companies. Dr. Leong has been an advisor to Ferring Pharmaceuticals and has been a speaker on behalf of Janssen. Dr. Yusuf had no disclosures.

[email protected]

This story was updated 9/19/2019.

PARIS – Middle-aged adults with a body mass index of 25-29 kg/m² had a significantly better adjusted survival during a median follow-up of nearly 10 years than did people with a “normal” body mass index of 20-24 kg/m² in a worldwide study of more than 140,000. This finding suggests the current, widely accepted definition of normal body mass index is wrong.*

Mitchel L. Zoler/MDedge News

The new findings suggest that the current definition of a “healthy” body mass index (BMI) “should be re-evaluated,” Darryl P. Leong, MBBS, said at the annual Congress of the European Society of Cardiology. The analysis also identified a BMI specifically of 27 kg/m² as associated with optimal survival among both women and men, “clearly outside the range of 20 to less than 25 kg/m² that is considered normal,” said Dr. Leong, a cardiologist at McMaster University and the Population Health Research Institute, both in Hamilton, Ont.

Dr. Leong cited three potential explanations for why the new study identified optimal survival with a BMI of 25 to less than 30 kg/m² among people who were 35-70 years old when they entered the study and were followed for a median of 9.5 years: The current study collected data and adjusted the results using a wider range of potential confounders than in prior studies, the data reflect the impact of contemporary interventions to reduce cardiovascular disease illness and death while past studies relied on data from earlier times when less cardiovascular disease protection occurred, and the current study included people from lower-income countries, although the finding is just as applicable to people who live in high-income countries, who were also included in the study population, noted Salim Yusuf, MBBS, principal investigator for the study.

A BMI of 20-24 kg/m² “is actually low and harmful,” noted Dr. Yusuf in an interview. Despite recent data consistently showing better survival among people with a BMI of 25-29 kg/m², panels that have recently written weight guidelines are “ossified” and “refuse to accept” the implications of these findings, said Dr. Yusuf, professor of medicine at McMaster and executive director of the Population Health Research Institute.

The results of the analyses that Dr. Leong reported also showed that BMI paled as a prognosticator for survival when compared with two other assessments of weight: waist/hip ratio, and even more powerful prognostically, a novel measure developed for this analysis that calculates the ratio of hand-grip strength/body weight. Waist/hip ratio adds the dimension of the location of body fat rather than just the amount, and the ratio of grip strength/body weight assesses the contribution of muscle mass to overall weight, noted Dr. Leong. He reported an optimal waist/hip ratio for survival of 0.83 in women and 0.93 in men, and an optimal strength/weight ratio of 0.42 in women and 0.50 in men. This means that a man whose hand-grip strength (measured in kg) is half of the person’s body weight has the best prospect for survival.
 
The study used data collected in PURE (Prospective Urban Rural Epidemiology Study) on 142,410 people aged 35-70 years from any one of four high-income countries, 12 middle-income countries, and five low-income countries. The study excluded people who had at baseline known coronary artery disease, stroke, heart failure, or cancer, and the adjusted analysis controlled for age, sex, region, education, activity, alcohol and tobacco use, and the baseline prevalence of hypertension and diabetes. During follow-up, 9,712 of these people died.

The researchers saw a nadir for mortality among people with a BMI of 25-29 kg/m² for both cardiovascular and noncardiovascular deaths. In addition, the link between total mortality and BMI was strongest in the subgroup of people on one or more treatments aimed at preventing cardiovascular disease, while it essentially disappeared among people not receiving any cardiovascular disease preventive measures, highlighting that the relationship now identified depends on a context of overall cardiovascular disease risk reduction, Dr. Leong said. The results also showed a very clear, direct, linear relationship between higher BMI and both the incidence of diabetes and cardiovascular disease, as well as increased all-cause and noncardiovascular mortality among people with a BMI of less than 20 kg/m².

Dr. Yusuf discussed the results of the analysis in a video interview.

The PURE study has received partial funding from unrestricted grants from several drug companies. Dr. Leong has been an advisor to Ferring Pharmaceuticals and has been a speaker on behalf of Janssen. Dr. Yusuf had no disclosures.

[email protected]

This story was updated 9/19/2019.

PARIS – In rural Peru, a comprehensive community-wide strategy to replace conventional table salt with a formulation that was 25% potassium chloride halved incident hypertension, also dropping blood pressure in participants with baseline hypertension.

The multifaceted intervention targeted six villages at the far north of Peru, replacing table salt with the lower-sodium substitute, J. Jaime Miranda, MD, PhD, said at a prevention-focused, late-breaking research session at the annual congress of the European Society of Cardiology. The 75/25 mixture had a palatable proportion of potassium, and was easily produced by combining table salt with potassium chloride crystals.

Dr. Miranda, director of the CRONICAS Center of Excellence at the Cayetano Heredia Peruvian University, Lima, and colleagues enrolled virtually all adult residents of the six villages in the study; patients who reported heart disease or chronic kidney disease were excluded.

“We wanted to achieve and shape a pragmatic study – and a pragmatic study that incorporates day-to-day behavior. We eat every day, but we think very little of our salt habits,” said Dr. Miranda in a video interview.

In all, 2,376 of 2,605 potential participants enrolled in the study, which used a stepped-wedge, cluster-randomized, controlled trial design. To track the primary outcome measures of systolic and diastolic BP, measurements were obtained every 5 months for a total of seven rounds of measurement, said Dr. Miranda.

Dr. Miranda said that the investigators borrowed principles from social marketing to ensure community-wide replacement of table salt with the low-sodium substitute. This meant that they branded and packaged the low-sodium salt and gave it to participants at no cost – but with a catch. To receive the low-sodium salt, participants had to turn in their table salt.

The effort was supported by promotional events and a trained “sales force” who brought messaging to families, restaurants, and key voices in the community. The attractively packaged replacement salt was distributed with a similarly branded shaker. “We wanted to guarantee the full replacement of salt in the entire village,” explained Dr. Miranda.

At the end of the study, individuals with hypertension saw a decrease in systolic BP of 1.92 mm Hg (95% confidence interval, –3.29 to –0.54).

New hypertension diagnoses, a secondary outcome measure, fell by 55% in participating villages; the hazard ratio for hypertension incidence was 0.45 (95% CI, 0.31-0.66) in a fully adjusted statistical model that accounted for clustering at the village level, as well as age, sex, education, wealth index, and body mass index, said Dr. Miranda.

Older village residents with hypertension saw greater BP reduction; for those aged at least 60 years, the mean reduction was 2.17 mm Hg (95% CI, –3.67 to –0.68).

The positive findings were met with broad applause during his presentation, a response that made his 15-hour trip from Lima to Paris worthwhile, said Dr. Miranda.

Adherence was assessed by obtaining 24-hour urine samples from a random sample of 100 participants before and after the study. “This was my biggest fear – that as soon as we left the door, people would go and throw it away,” said Dr. Miranda. Among these participants, excreted potassium rose, indicating adherence, but sodium stayed basically the same. Possible explanations included that individuals were adding table salt to their diets, or that other prepared foods or condiments contained high amounts of sodium.

The study shows the feasibility of a community-wide intervention that achieved the dual aims of population-wide reductions in BP and reduction in incident BP, and of achieving clinically meaningful benefits for the high-risk population, said Dr. Miranda. He remarked that the population was young overall, with a mean age of 43 years and a low mean baseline systolic BP of 113, making the modest population-wide reduction more notable.

“We wanted to shift the entire distribution of blood pressure in the village. And with that, we see gains not only in public health, but also effective improvements in blood pressure in those at high risk, particularly those who tend to have high blood pressure,” said Dr. Miranda.

Discussant Bruce Neal, MD, professor of medicine at the University of Sydney and senior director of the George Institute for Global Health in Newtown, Australia, congratulated Dr. Miranda and colleagues on accomplishing “a truly enormous project.” He began by noting that, though the reductions were modest, “the low starting blood pressures were almost certainly responsible for the magnitude of effect seen in this study.” He added that “this is nonetheless a worthwhile blood pressure reduction, particularly if it was sustained throughout life.”

Addressing the lack of decrease in excreted urine sodium, Dr. Neal noted that participants may have supplemented their diet with additional sodium by one means or another, “which might also have attenuated the blood pressure difference – but it could also reflect the challenges of measuring sodium and potassium effectively with 24-hour urine samples, which are difficult to collect.”

The lack of adverse effects was notable, said Dr. Neal. “When considering the use of salt substitute at the population level, the first question that arises is: ‘What about the risks of hyperkalemia?’

“I think those risks are probably greatly overstated,” he said, noting that only individuals with severe chronic kidney disease would likely be affected, and those individuals are already well versed on the importance of avoiding excess dietary potassium.

The study was funded by the National Institutes of Health through the Global Alliance for Chronic Disease program. Dr. Miranda reported that he had no conflicts of interest. Dr. Neal reported that he has financial relationships with Nu-Tec Salt and a Beijing-based salt manufacturer, related to research into salt substitutes.

PARIS – In rural Peru, a comprehensive community-wide strategy to replace conventional table salt with a formulation that was 25% potassium chloride halved incident hypertension, also dropping blood pressure in participants with baseline hypertension.

The multifaceted intervention targeted six villages at the far north of Peru, replacing table salt with the lower-sodium substitute, J. Jaime Miranda, MD, PhD, said at a prevention-focused, late-breaking research session at the annual congress of the European Society of Cardiology. The 75/25 mixture had a palatable proportion of potassium, and was easily produced by combining table salt with potassium chloride crystals.

Dr. Miranda, director of the CRONICAS Center of Excellence at the Cayetano Heredia Peruvian University, Lima, and colleagues enrolled virtually all adult residents of the six villages in the study; patients who reported heart disease or chronic kidney disease were excluded.

“We wanted to achieve and shape a pragmatic study – and a pragmatic study that incorporates day-to-day behavior. We eat every day, but we think very little of our salt habits,” said Dr. Miranda in a video interview.

In all, 2,376 of 2,605 potential participants enrolled in the study, which used a stepped-wedge, cluster-randomized, controlled trial design. To track the primary outcome measures of systolic and diastolic BP, measurements were obtained every 5 months for a total of seven rounds of measurement, said Dr. Miranda.

Dr. Miranda said that the investigators borrowed principles from social marketing to ensure community-wide replacement of table salt with the low-sodium substitute. This meant that they branded and packaged the low-sodium salt and gave it to participants at no cost – but with a catch. To receive the low-sodium salt, participants had to turn in their table salt.

The effort was supported by promotional events and a trained “sales force” who brought messaging to families, restaurants, and key voices in the community. The attractively packaged replacement salt was distributed with a similarly branded shaker. “We wanted to guarantee the full replacement of salt in the entire village,” explained Dr. Miranda.

At the end of the study, individuals with hypertension saw a decrease in systolic BP of 1.92 mm Hg (95% confidence interval, –3.29 to –0.54).

New hypertension diagnoses, a secondary outcome measure, fell by 55% in participating villages; the hazard ratio for hypertension incidence was 0.45 (95% CI, 0.31-0.66) in a fully adjusted statistical model that accounted for clustering at the village level, as well as age, sex, education, wealth index, and body mass index, said Dr. Miranda.

Older village residents with hypertension saw greater BP reduction; for those aged at least 60 years, the mean reduction was 2.17 mm Hg (95% CI, –3.67 to –0.68).

The positive findings were met with broad applause during his presentation, a response that made his 15-hour trip from Lima to Paris worthwhile, said Dr. Miranda.

Adherence was assessed by obtaining 24-hour urine samples from a random sample of 100 participants before and after the study. “This was my biggest fear – that as soon as we left the door, people would go and throw it away,” said Dr. Miranda. Among these participants, excreted potassium rose, indicating adherence, but sodium stayed basically the same. Possible explanations included that individuals were adding table salt to their diets, or that other prepared foods or condiments contained high amounts of sodium.

The study shows the feasibility of a community-wide intervention that achieved the dual aims of population-wide reductions in BP and reduction in incident BP, and of achieving clinically meaningful benefits for the high-risk population, said Dr. Miranda. He remarked that the population was young overall, with a mean age of 43 years and a low mean baseline systolic BP of 113, making the modest population-wide reduction more notable.

“We wanted to shift the entire distribution of blood pressure in the village. And with that, we see gains not only in public health, but also effective improvements in blood pressure in those at high risk, particularly those who tend to have high blood pressure,” said Dr. Miranda.

Discussant Bruce Neal, MD, professor of medicine at the University of Sydney and senior director of the George Institute for Global Health in Newtown, Australia, congratulated Dr. Miranda and colleagues on accomplishing “a truly enormous project.” He began by noting that, though the reductions were modest, “the low starting blood pressures were almost certainly responsible for the magnitude of effect seen in this study.” He added that “this is nonetheless a worthwhile blood pressure reduction, particularly if it was sustained throughout life.”

Addressing the lack of decrease in excreted urine sodium, Dr. Neal noted that participants may have supplemented their diet with additional sodium by one means or another, “which might also have attenuated the blood pressure difference – but it could also reflect the challenges of measuring sodium and potassium effectively with 24-hour urine samples, which are difficult to collect.”

The lack of adverse effects was notable, said Dr. Neal. “When considering the use of salt substitute at the population level, the first question that arises is: ‘What about the risks of hyperkalemia?’

“I think those risks are probably greatly overstated,” he said, noting that only individuals with severe chronic kidney disease would likely be affected, and those individuals are already well versed on the importance of avoiding excess dietary potassium.

The study was funded by the National Institutes of Health through the Global Alliance for Chronic Disease program. Dr. Miranda reported that he had no conflicts of interest. Dr. Neal reported that he has financial relationships with Nu-Tec Salt and a Beijing-based salt manufacturer, related to research into salt substitutes.

PARIS – In rural Peru, a comprehensive community-wide strategy to replace conventional table salt with a formulation that was 25% potassium chloride halved incident hypertension, also dropping blood pressure in participants with baseline hypertension.

The multifaceted intervention targeted six villages at the far north of Peru, replacing table salt with the lower-sodium substitute, J. Jaime Miranda, MD, PhD, said at a prevention-focused, late-breaking research session at the annual congress of the European Society of Cardiology. The 75/25 mixture had a palatable proportion of potassium, and was easily produced by combining table salt with potassium chloride crystals.

Dr. Miranda, director of the CRONICAS Center of Excellence at the Cayetano Heredia Peruvian University, Lima, and colleagues enrolled virtually all adult residents of the six villages in the study; patients who reported heart disease or chronic kidney disease were excluded.

“We wanted to achieve and shape a pragmatic study – and a pragmatic study that incorporates day-to-day behavior. We eat every day, but we think very little of our salt habits,” said Dr. Miranda in a video interview.

In all, 2,376 of 2,605 potential participants enrolled in the study, which used a stepped-wedge, cluster-randomized, controlled trial design. To track the primary outcome measures of systolic and diastolic BP, measurements were obtained every 5 months for a total of seven rounds of measurement, said Dr. Miranda.

Dr. Miranda said that the investigators borrowed principles from social marketing to ensure community-wide replacement of table salt with the low-sodium substitute. This meant that they branded and packaged the low-sodium salt and gave it to participants at no cost – but with a catch. To receive the low-sodium salt, participants had to turn in their table salt.

The effort was supported by promotional events and a trained “sales force” who brought messaging to families, restaurants, and key voices in the community. The attractively packaged replacement salt was distributed with a similarly branded shaker. “We wanted to guarantee the full replacement of salt in the entire village,” explained Dr. Miranda.

At the end of the study, individuals with hypertension saw a decrease in systolic BP of 1.92 mm Hg (95% confidence interval, –3.29 to –0.54).

New hypertension diagnoses, a secondary outcome measure, fell by 55% in participating villages; the hazard ratio for hypertension incidence was 0.45 (95% CI, 0.31-0.66) in a fully adjusted statistical model that accounted for clustering at the village level, as well as age, sex, education, wealth index, and body mass index, said Dr. Miranda.

Older village residents with hypertension saw greater BP reduction; for those aged at least 60 years, the mean reduction was 2.17 mm Hg (95% CI, –3.67 to –0.68).

The positive findings were met with broad applause during his presentation, a response that made his 15-hour trip from Lima to Paris worthwhile, said Dr. Miranda.

Adherence was assessed by obtaining 24-hour urine samples from a random sample of 100 participants before and after the study. “This was my biggest fear – that as soon as we left the door, people would go and throw it away,” said Dr. Miranda. Among these participants, excreted potassium rose, indicating adherence, but sodium stayed basically the same. Possible explanations included that individuals were adding table salt to their diets, or that other prepared foods or condiments contained high amounts of sodium.

The study shows the feasibility of a community-wide intervention that achieved the dual aims of population-wide reductions in BP and reduction in incident BP, and of achieving clinically meaningful benefits for the high-risk population, said Dr. Miranda. He remarked that the population was young overall, with a mean age of 43 years and a low mean baseline systolic BP of 113, making the modest population-wide reduction more notable.

“We wanted to shift the entire distribution of blood pressure in the village. And with that, we see gains not only in public health, but also effective improvements in blood pressure in those at high risk, particularly those who tend to have high blood pressure,” said Dr. Miranda.

Discussant Bruce Neal, MD, professor of medicine at the University of Sydney and senior director of the George Institute for Global Health in Newtown, Australia, congratulated Dr. Miranda and colleagues on accomplishing “a truly enormous project.” He began by noting that, though the reductions were modest, “the low starting blood pressures were almost certainly responsible for the magnitude of effect seen in this study.” He added that “this is nonetheless a worthwhile blood pressure reduction, particularly if it was sustained throughout life.”

Addressing the lack of decrease in excreted urine sodium, Dr. Neal noted that participants may have supplemented their diet with additional sodium by one means or another, “which might also have attenuated the blood pressure difference – but it could also reflect the challenges of measuring sodium and potassium effectively with 24-hour urine samples, which are difficult to collect.”

The lack of adverse effects was notable, said Dr. Neal. “When considering the use of salt substitute at the population level, the first question that arises is: ‘What about the risks of hyperkalemia?’

“I think those risks are probably greatly overstated,” he said, noting that only individuals with severe chronic kidney disease would likely be affected, and those individuals are already well versed on the importance of avoiding excess dietary potassium.

The study was funded by the National Institutes of Health through the Global Alliance for Chronic Disease program. Dr. Miranda reported that he had no conflicts of interest. Dr. Neal reported that he has financial relationships with Nu-Tec Salt and a Beijing-based salt manufacturer, related to research into salt substitutes.

PARIS – Treatment with the SGLT2 inhibitor dapagliflozin produced a statistically significant 27% drop in cardiovascular death or heart failure events in patients with existing heart failure with reduced ejection fraction and no diabetes, results that in a stroke changed the status of dapagliflozin from fundamentally a drug that treats diabetes to a drug that treats heart failure.

Mitchel L. Zoler/MDedge News

“Dapagliflozin offers a new approach to the treatment of heart failure with reduced ejection fraction” (HFrEF), John McMurray, MD, said at the annual congress of the European Society of Cardiology.

The results he reported from the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial showed statistically significant benefits when adding dapagliflozin to guideline-directed therapy for a list of outcomes that include a 17% drop in all-cause death compared with placebo, an 18% fall in cardiovascular death, and a 25% relative reduction in total heart failure hospitalizations plus cardiovascular deaths during a median follow-up of just over 18 months. The primary endpoint of the reduction in cardiovascular death, first heart failure hospitalization, or an urgent heart failure visit fell by 25% in the enrolled patients with diabetes (45% of the study population, all with type 2 diabetes), and by 27% in the remaining patients who had no diabetes, showing that the presence of diabetes had no impact on the heart failure benefit from dapagliflozin (Farxiga). The absolute reduction in the primary endpoint was about 5%, with a number needed to treat of 21 to prevent one primary endpoint during 18 months of treatment.

Dr. McMurray’s report of the primary endpoint as well as the finding that the drug was as effective in patients without diabetes as in those with diabetes were both met with loud applause by the packed congress audience.

The efficacy results also showed that 58% of patients on dapagliflozin had a clinically meaningful (5 point or greater) increase in their quality of life score on the Kansas City Cardiomyopathy Questionnaire after 8 months on treatment compared with a 51% rate in the placebo patients, a statistically significant difference.

The safety results showed no new signals for a drug that already has regulatory approval but was being used in a novel population. The rate of major hypoglycemia was virtually nonexistent, 0.2%, and identical in both treatment arms. All adverse events occurred at roughly equal rates in the dapagliflozin and placebo groups, with a 5% rate of adverse events leading to study discontinuation in both arms, and a serious adverse event rate of 38% in the dapaglifolzin patients and 42% in the placebo patients. The rate of worsening renal function was less than 2% in both arms and not statistically different.

“This is as close to a home run as you see in heart failure treatment,” commented Douglas L. Mann, MD, professor of medicine at Washington University, St. Louis, and a heart failure clinician and researcher.

DAPA-HF “is a landmark trial. It took a diabetes drug and used it in patients without diabetes, a concept that would have been considered outlandish 5 years ago. Scientifically it’s huge,” commented Deepak L. Bhatt, MD, professor of medicine at Harvard Medical School in Boston.

The DAPA-HF results were another step in the remarkable journey toward heart failure intervention taken by the SGLT2 (sodium glucose cotransport 2) inhibitor class of drugs that includes dapagliflozin as well as canagliflozin (Invokana) and empagliflozin(Jardiance), a path that began 4 years ago with the report of empagliflozin’s unexpected efficacy for reducing cardiovascular death and heart failure hospitalizations in a large cardiovascular-safety study, EMPA-REG OUTCOME (N Engl J Med. 2015 Nov 26;373[22]:2117-28). Subsequent reports showed similar effects benefiting heart failure and survival for canagliflozin and dapagliflozin, and now with DAPA-HF the evidence extended the benefit to heart failure patients regardless of whether they have diabetes. Additional studies now in progress are exploring the same question for empagliflozin and canagliflozin.

The results from DAPA-HF are likely a class effect for all these SGLT2 inhibitors, suggested Dr. McMurray in a video interview, a view shared by several other experts. He cautioned clinicians against using dapagliflozin to treat patients with heart failure with reduced ejection fraction (HFrEF) but without diabetes until this indication receives regulatory approval, and even then using dapagliflozin or other SGLT2 inhibitors this way may take some getting used to on the part of cardiologists and other clinicians.

“The results put dapagliflozin in the same league as [standard HFrEF drugs], but using it will require a shift in thinking. Most physicians will initially say “aren’t SGLT2 inhibitors used for treating diabetes?” Dr. Bhatt said.

“I’m sure most cardiologists are not familiar with the SGLT2 inhibitors; we’ll have to educate them,” conceded Dr. McMurray, professor of medical cardiology at the University of Glasgow. However, other aspects of dapagliflozin and this drug class in general may make the SGLT2 inhibitors particularly attractive and spur their use once labeling changes.

[email protected]

PARIS – Treatment with the SGLT2 inhibitor dapagliflozin produced a statistically significant 27% drop in cardiovascular death or heart failure events in patients with existing heart failure with reduced ejection fraction and no diabetes, results that in a stroke changed the status of dapagliflozin from fundamentally a drug that treats diabetes to a drug that treats heart failure.

Mitchel L. Zoler/MDedge News

“Dapagliflozin offers a new approach to the treatment of heart failure with reduced ejection fraction” (HFrEF), John McMurray, MD, said at the annual congress of the European Society of Cardiology.

The results he reported from the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial showed statistically significant benefits when adding dapagliflozin to guideline-directed therapy for a list of outcomes that include a 17% drop in all-cause death compared with placebo, an 18% fall in cardiovascular death, and a 25% relative reduction in total heart failure hospitalizations plus cardiovascular deaths during a median follow-up of just over 18 months. The primary endpoint of the reduction in cardiovascular death, first heart failure hospitalization, or an urgent heart failure visit fell by 25% in the enrolled patients with diabetes (45% of the study population, all with type 2 diabetes), and by 27% in the remaining patients who had no diabetes, showing that the presence of diabetes had no impact on the heart failure benefit from dapagliflozin (Farxiga). The absolute reduction in the primary endpoint was about 5%, with a number needed to treat of 21 to prevent one primary endpoint during 18 months of treatment.

Dr. McMurray’s report of the primary endpoint as well as the finding that the drug was as effective in patients without diabetes as in those with diabetes were both met with loud applause by the packed congress audience.

The efficacy results also showed that 58% of patients on dapagliflozin had a clinically meaningful (5 point or greater) increase in their quality of life score on the Kansas City Cardiomyopathy Questionnaire after 8 months on treatment compared with a 51% rate in the placebo patients, a statistically significant difference.

The safety results showed no new signals for a drug that already has regulatory approval but was being used in a novel population. The rate of major hypoglycemia was virtually nonexistent, 0.2%, and identical in both treatment arms. All adverse events occurred at roughly equal rates in the dapagliflozin and placebo groups, with a 5% rate of adverse events leading to study discontinuation in both arms, and a serious adverse event rate of 38% in the dapaglifolzin patients and 42% in the placebo patients. The rate of worsening renal function was less than 2% in both arms and not statistically different.

“This is as close to a home run as you see in heart failure treatment,” commented Douglas L. Mann, MD, professor of medicine at Washington University, St. Louis, and a heart failure clinician and researcher.

DAPA-HF “is a landmark trial. It took a diabetes drug and used it in patients without diabetes, a concept that would have been considered outlandish 5 years ago. Scientifically it’s huge,” commented Deepak L. Bhatt, MD, professor of medicine at Harvard Medical School in Boston.

The DAPA-HF results were another step in the remarkable journey toward heart failure intervention taken by the SGLT2 (sodium glucose cotransport 2) inhibitor class of drugs that includes dapagliflozin as well as canagliflozin (Invokana) and empagliflozin(Jardiance), a path that began 4 years ago with the report of empagliflozin’s unexpected efficacy for reducing cardiovascular death and heart failure hospitalizations in a large cardiovascular-safety study, EMPA-REG OUTCOME (N Engl J Med. 2015 Nov 26;373[22]:2117-28). Subsequent reports showed similar effects benefiting heart failure and survival for canagliflozin and dapagliflozin, and now with DAPA-HF the evidence extended the benefit to heart failure patients regardless of whether they have diabetes. Additional studies now in progress are exploring the same question for empagliflozin and canagliflozin.

The results from DAPA-HF are likely a class effect for all these SGLT2 inhibitors, suggested Dr. McMurray in a video interview, a view shared by several other experts. He cautioned clinicians against using dapagliflozin to treat patients with heart failure with reduced ejection fraction (HFrEF) but without diabetes until this indication receives regulatory approval, and even then using dapagliflozin or other SGLT2 inhibitors this way may take some getting used to on the part of cardiologists and other clinicians.

“The results put dapagliflozin in the same league as [standard HFrEF drugs], but using it will require a shift in thinking. Most physicians will initially say “aren’t SGLT2 inhibitors used for treating diabetes?” Dr. Bhatt said.

“I’m sure most cardiologists are not familiar with the SGLT2 inhibitors; we’ll have to educate them,” conceded Dr. McMurray, professor of medical cardiology at the University of Glasgow. However, other aspects of dapagliflozin and this drug class in general may make the SGLT2 inhibitors particularly attractive and spur their use once labeling changes.

[email protected]

PARIS – Treatment with the SGLT2 inhibitor dapagliflozin produced a statistically significant 27% drop in cardiovascular death or heart failure events in patients with existing heart failure with reduced ejection fraction and no diabetes, results that in a stroke changed the status of dapagliflozin from fundamentally a drug that treats diabetes to a drug that treats heart failure.

Mitchel L. Zoler/MDedge News

“Dapagliflozin offers a new approach to the treatment of heart failure with reduced ejection fraction” (HFrEF), John McMurray, MD, said at the annual congress of the European Society of Cardiology.

The results he reported from the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial showed statistically significant benefits when adding dapagliflozin to guideline-directed therapy for a list of outcomes that include a 17% drop in all-cause death compared with placebo, an 18% fall in cardiovascular death, and a 25% relative reduction in total heart failure hospitalizations plus cardiovascular deaths during a median follow-up of just over 18 months. The primary endpoint of the reduction in cardiovascular death, first heart failure hospitalization, or an urgent heart failure visit fell by 25% in the enrolled patients with diabetes (45% of the study population, all with type 2 diabetes), and by 27% in the remaining patients who had no diabetes, showing that the presence of diabetes had no impact on the heart failure benefit from dapagliflozin (Farxiga). The absolute reduction in the primary endpoint was about 5%, with a number needed to treat of 21 to prevent one primary endpoint during 18 months of treatment.

Dr. McMurray’s report of the primary endpoint as well as the finding that the drug was as effective in patients without diabetes as in those with diabetes were both met with loud applause by the packed congress audience.

The efficacy results also showed that 58% of patients on dapagliflozin had a clinically meaningful (5 point or greater) increase in their quality of life score on the Kansas City Cardiomyopathy Questionnaire after 8 months on treatment compared with a 51% rate in the placebo patients, a statistically significant difference.

The safety results showed no new signals for a drug that already has regulatory approval but was being used in a novel population. The rate of major hypoglycemia was virtually nonexistent, 0.2%, and identical in both treatment arms. All adverse events occurred at roughly equal rates in the dapagliflozin and placebo groups, with a 5% rate of adverse events leading to study discontinuation in both arms, and a serious adverse event rate of 38% in the dapaglifolzin patients and 42% in the placebo patients. The rate of worsening renal function was less than 2% in both arms and not statistically different.

“This is as close to a home run as you see in heart failure treatment,” commented Douglas L. Mann, MD, professor of medicine at Washington University, St. Louis, and a heart failure clinician and researcher.

DAPA-HF “is a landmark trial. It took a diabetes drug and used it in patients without diabetes, a concept that would have been considered outlandish 5 years ago. Scientifically it’s huge,” commented Deepak L. Bhatt, MD, professor of medicine at Harvard Medical School in Boston.

The DAPA-HF results were another step in the remarkable journey toward heart failure intervention taken by the SGLT2 (sodium glucose cotransport 2) inhibitor class of drugs that includes dapagliflozin as well as canagliflozin (Invokana) and empagliflozin(Jardiance), a path that began 4 years ago with the report of empagliflozin’s unexpected efficacy for reducing cardiovascular death and heart failure hospitalizations in a large cardiovascular-safety study, EMPA-REG OUTCOME (N Engl J Med. 2015 Nov 26;373[22]:2117-28). Subsequent reports showed similar effects benefiting heart failure and survival for canagliflozin and dapagliflozin, and now with DAPA-HF the evidence extended the benefit to heart failure patients regardless of whether they have diabetes. Additional studies now in progress are exploring the same question for empagliflozin and canagliflozin.

The results from DAPA-HF are likely a class effect for all these SGLT2 inhibitors, suggested Dr. McMurray in a video interview, a view shared by several other experts. He cautioned clinicians against using dapagliflozin to treat patients with heart failure with reduced ejection fraction (HFrEF) but without diabetes until this indication receives regulatory approval, and even then using dapagliflozin or other SGLT2 inhibitors this way may take some getting used to on the part of cardiologists and other clinicians.

“The results put dapagliflozin in the same league as [standard HFrEF drugs], but using it will require a shift in thinking. Most physicians will initially say “aren’t SGLT2 inhibitors used for treating diabetes?” Dr. Bhatt said.

“I’m sure most cardiologists are not familiar with the SGLT2 inhibitors; we’ll have to educate them,” conceded Dr. McMurray, professor of medical cardiology at the University of Glasgow. However, other aspects of dapagliflozin and this drug class in general may make the SGLT2 inhibitors particularly attractive and spur their use once labeling changes.

[email protected]

A community-based care model to control hypertension led by nonphysician health care workers significantly reduced cardiovascular disease risk over 12 months, data from a cluster-controlled randomized study has shown.

Hypertension remains the most common risk factor for cardiovascular disease, but fewer than 20% of individuals with hypertension have their blood pressure controlled, wrote Jon-David Schwalm, MD, of McMaster University in Hamilton, Ont., and colleagues. To help control hypertension in underserved populations, the researchers tested a care model involving nonphysician health workers (NPHWs), primary care physicians, and family members.

The HOPE4 study, presented at the annual congress of the European Society of Cardiology and published simultaneously in the Lancet, included 1,371 adults aged 50 years and older with new or poorly controlled hypertension from 30 communities in Colombia and Malaysia. Sixteen communities were randomized to usual care and 14 to an intervention. The intervention included community screening and treatment of cardiovascular disease risk factors by NPHWs, free medications recommended by NPHWs under physician supervision, and family support for treatment adherence.

After 12 months, the Framingham Risk Scores for 10-year cardiovascular disease risk were significantly lower in the intervention group, compared with the control group (–11.17% vs. –6.40%). In addition, the intervention group showed a significant 11.45 mm Hg greater reduction in systolic blood pressure and a significant 0.41 mmol/L reduction in LDL cholesterol, compared with controls (P less than .0001 for both measures).

Baseline characteristics were similar between the two groups. Approximately 74% of the participants had a history of poorly controlled hypertension, while the remaining patients had new hypertension diagnoses.

“NPHWs were found to be consistently accurate in their ability to identify cardiovascular risk (patient identified by NPHWs as having poorly controlled blood pressure and medication was indicated) and recommend appropriate therapies (antihypertensives and statin as per the study algorithm) when compared with the assessment by local primary care physicians,” the researchers wrote. The study shows how effectively NPHWs can help reduce cardiovascular disease risk at the community level with proper training, effective community outreach, and task sharing with physicians and family members, they noted.

The findings were limited by the inability to assess the safety of specific medications, but no differences in adverse events were reported between the intervention and control groups. Other limitations included the screening of controls for cardiovascular disease risk at baseline, which meant that controls may have modified their behavior as a result, the researchers noted. In addition, the study was not blinded and surrogate outcomes were used because of the short study duration and relatively small sample size, they said.

However, the results support the use of a comprehensive, NPHW-led model, and “the HOPE 4 strategy could help to attain the UN General Assembly Action Plan for a one-third reduction in premature mortality from cardiovascular disease” by 2030, the researchers concluded.

The study was supported by the Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, World Health Organization; and the Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.

SOURCE: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.

A community-based care model to control hypertension led by nonphysician health care workers significantly reduced cardiovascular disease risk over 12 months, data from a cluster-controlled randomized study has shown.

Hypertension remains the most common risk factor for cardiovascular disease, but fewer than 20% of individuals with hypertension have their blood pressure controlled, wrote Jon-David Schwalm, MD, of McMaster University in Hamilton, Ont., and colleagues. To help control hypertension in underserved populations, the researchers tested a care model involving nonphysician health workers (NPHWs), primary care physicians, and family members.

The HOPE4 study, presented at the annual congress of the European Society of Cardiology and published simultaneously in the Lancet, included 1,371 adults aged 50 years and older with new or poorly controlled hypertension from 30 communities in Colombia and Malaysia. Sixteen communities were randomized to usual care and 14 to an intervention. The intervention included community screening and treatment of cardiovascular disease risk factors by NPHWs, free medications recommended by NPHWs under physician supervision, and family support for treatment adherence.

After 12 months, the Framingham Risk Scores for 10-year cardiovascular disease risk were significantly lower in the intervention group, compared with the control group (–11.17% vs. –6.40%). In addition, the intervention group showed a significant 11.45 mm Hg greater reduction in systolic blood pressure and a significant 0.41 mmol/L reduction in LDL cholesterol, compared with controls (P less than .0001 for both measures).

Baseline characteristics were similar between the two groups. Approximately 74% of the participants had a history of poorly controlled hypertension, while the remaining patients had new hypertension diagnoses.

“NPHWs were found to be consistently accurate in their ability to identify cardiovascular risk (patient identified by NPHWs as having poorly controlled blood pressure and medication was indicated) and recommend appropriate therapies (antihypertensives and statin as per the study algorithm) when compared with the assessment by local primary care physicians,” the researchers wrote. The study shows how effectively NPHWs can help reduce cardiovascular disease risk at the community level with proper training, effective community outreach, and task sharing with physicians and family members, they noted.

The findings were limited by the inability to assess the safety of specific medications, but no differences in adverse events were reported between the intervention and control groups. Other limitations included the screening of controls for cardiovascular disease risk at baseline, which meant that controls may have modified their behavior as a result, the researchers noted. In addition, the study was not blinded and surrogate outcomes were used because of the short study duration and relatively small sample size, they said.

However, the results support the use of a comprehensive, NPHW-led model, and “the HOPE 4 strategy could help to attain the UN General Assembly Action Plan for a one-third reduction in premature mortality from cardiovascular disease” by 2030, the researchers concluded.

The study was supported by the Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, World Health Organization; and the Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.

SOURCE: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.

A community-based care model to control hypertension led by nonphysician health care workers significantly reduced cardiovascular disease risk over 12 months, data from a cluster-controlled randomized study has shown.

Hypertension remains the most common risk factor for cardiovascular disease, but fewer than 20% of individuals with hypertension have their blood pressure controlled, wrote Jon-David Schwalm, MD, of McMaster University in Hamilton, Ont., and colleagues. To help control hypertension in underserved populations, the researchers tested a care model involving nonphysician health workers (NPHWs), primary care physicians, and family members.

The HOPE4 study, presented at the annual congress of the European Society of Cardiology and published simultaneously in the Lancet, included 1,371 adults aged 50 years and older with new or poorly controlled hypertension from 30 communities in Colombia and Malaysia. Sixteen communities were randomized to usual care and 14 to an intervention. The intervention included community screening and treatment of cardiovascular disease risk factors by NPHWs, free medications recommended by NPHWs under physician supervision, and family support for treatment adherence.

After 12 months, the Framingham Risk Scores for 10-year cardiovascular disease risk were significantly lower in the intervention group, compared with the control group (–11.17% vs. –6.40%). In addition, the intervention group showed a significant 11.45 mm Hg greater reduction in systolic blood pressure and a significant 0.41 mmol/L reduction in LDL cholesterol, compared with controls (P less than .0001 for both measures).

Baseline characteristics were similar between the two groups. Approximately 74% of the participants had a history of poorly controlled hypertension, while the remaining patients had new hypertension diagnoses.

“NPHWs were found to be consistently accurate in their ability to identify cardiovascular risk (patient identified by NPHWs as having poorly controlled blood pressure and medication was indicated) and recommend appropriate therapies (antihypertensives and statin as per the study algorithm) when compared with the assessment by local primary care physicians,” the researchers wrote. The study shows how effectively NPHWs can help reduce cardiovascular disease risk at the community level with proper training, effective community outreach, and task sharing with physicians and family members, they noted.

The findings were limited by the inability to assess the safety of specific medications, but no differences in adverse events were reported between the intervention and control groups. Other limitations included the screening of controls for cardiovascular disease risk at baseline, which meant that controls may have modified their behavior as a result, the researchers noted. In addition, the study was not blinded and surrogate outcomes were used because of the short study duration and relatively small sample size, they said.

However, the results support the use of a comprehensive, NPHW-led model, and “the HOPE 4 strategy could help to attain the UN General Assembly Action Plan for a one-third reduction in premature mortality from cardiovascular disease” by 2030, the researchers concluded.

The study was supported by the Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, World Health Organization; and the Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.

SOURCE: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.