Guidelines

Fludarabine, cyclophosphamide, and rituximab are recommended as initial therapy for patients with chronic lymphocytic leukemia who do not have TP53 disruption, according to new guidelines from the British Society for Haematology.

The guidelines update the 2012 recommendations on chronic lymphocytic leukemia (CLL) to include “significant” developments in treatment. They were published in the British Journal of Haematology.

Anna H. Schuh, MD, of the department of oncology at the University of Oxford (England), and her coauthors noted that, while these guidelines apply to treatments available outside clinical trials, wherever possible patients with CLL should be treated within the clinical trial setting.

While recommending fludarabine, cyclophosphamide, and rituximab as first-line therapy, the guideline authors acknowledged that the combination of bendamustine and rituximab is an acceptable alternative for patients who could not take the triple therapy because of comorbidities such as advanced age, renal impairment, or issues with marrow capacity.

Similarly, less-fit patients could also be considered for chlorambucil-obinutuzumab or chlorambucil-ofatumumab combinations.

All patients diagnosed with CLL should be tested for TP53 deletions and mutations before each line of therapy, the guideline committee recommended. TP53 disruption makes chemoimmunotherapy ineffective because of either a deletion of chromosome 17p or a mutation in the TP53 gene. However, there is compelling evidence for the efficacy of ibrutinib in these patients, or idelalisib and rituximab for those with cardiac disease or receiving vitamin K antagonists.

With respect to maintenance therapy, the guidelines noted that this was not routinely recommended in CLL as “it is unclear to what extent the progression-free survival benefit is offset by long-term toxicity.”

Patients who are refractory to chemoimmunotherapy, who have relapsed, or who cannot be retreated with chemoimmunotherapy should be treated with idelalisib with rituximab or ibrutinib monotherapy, the guidelines suggested.

“Deciding whether ibrutinib or idelalisib with rituximab is most appropriate for an individual patient depends on a range of factors, including toxicity profile and convenience of delivery,” the authors wrote. However, they noted that the value of adding bendamustine to either option was unclear as research had not shown significant, associated gains in median progression-free survival.

Allogeneic stem cell transplantation should be considered as a treatment option for patients who have either failed chemotherapy, have a TP53 disruption and have not responded to B-cell receptor signaling pathway inhibitors such as ibrutinib, or have a Richter transformation.

The guidelines also addressed the issue of autoimmune cytopenias, which occur in 5%-10% of patients with CLL and can actually precede the diagnosis of CLL in about 9% of cases.

In patients where autoimmune cytopenia is the dominant clinical feature, they should be treated with corticosteroids, intravenous immunoglobulin, or rituximab. However, for patients where the cytopenia is triggered by CLL therapy, the guidelines recommended halting treatment and beginning immunosuppression.

The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.

SOURCE: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.

Fludarabine, cyclophosphamide, and rituximab are recommended as initial therapy for patients with chronic lymphocytic leukemia who do not have TP53 disruption, according to new guidelines from the British Society for Haematology.

The guidelines update the 2012 recommendations on chronic lymphocytic leukemia (CLL) to include “significant” developments in treatment. They were published in the British Journal of Haematology.

Anna H. Schuh, MD, of the department of oncology at the University of Oxford (England), and her coauthors noted that, while these guidelines apply to treatments available outside clinical trials, wherever possible patients with CLL should be treated within the clinical trial setting.

While recommending fludarabine, cyclophosphamide, and rituximab as first-line therapy, the guideline authors acknowledged that the combination of bendamustine and rituximab is an acceptable alternative for patients who could not take the triple therapy because of comorbidities such as advanced age, renal impairment, or issues with marrow capacity.

Similarly, less-fit patients could also be considered for chlorambucil-obinutuzumab or chlorambucil-ofatumumab combinations.

All patients diagnosed with CLL should be tested for TP53 deletions and mutations before each line of therapy, the guideline committee recommended. TP53 disruption makes chemoimmunotherapy ineffective because of either a deletion of chromosome 17p or a mutation in the TP53 gene. However, there is compelling evidence for the efficacy of ibrutinib in these patients, or idelalisib and rituximab for those with cardiac disease or receiving vitamin K antagonists.

With respect to maintenance therapy, the guidelines noted that this was not routinely recommended in CLL as “it is unclear to what extent the progression-free survival benefit is offset by long-term toxicity.”

Patients who are refractory to chemoimmunotherapy, who have relapsed, or who cannot be retreated with chemoimmunotherapy should be treated with idelalisib with rituximab or ibrutinib monotherapy, the guidelines suggested.

“Deciding whether ibrutinib or idelalisib with rituximab is most appropriate for an individual patient depends on a range of factors, including toxicity profile and convenience of delivery,” the authors wrote. However, they noted that the value of adding bendamustine to either option was unclear as research had not shown significant, associated gains in median progression-free survival.

Allogeneic stem cell transplantation should be considered as a treatment option for patients who have either failed chemotherapy, have a TP53 disruption and have not responded to B-cell receptor signaling pathway inhibitors such as ibrutinib, or have a Richter transformation.

The guidelines also addressed the issue of autoimmune cytopenias, which occur in 5%-10% of patients with CLL and can actually precede the diagnosis of CLL in about 9% of cases.

In patients where autoimmune cytopenia is the dominant clinical feature, they should be treated with corticosteroids, intravenous immunoglobulin, or rituximab. However, for patients where the cytopenia is triggered by CLL therapy, the guidelines recommended halting treatment and beginning immunosuppression.

The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.

SOURCE: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.

Fludarabine, cyclophosphamide, and rituximab are recommended as initial therapy for patients with chronic lymphocytic leukemia who do not have TP53 disruption, according to new guidelines from the British Society for Haematology.

The guidelines update the 2012 recommendations on chronic lymphocytic leukemia (CLL) to include “significant” developments in treatment. They were published in the British Journal of Haematology.

Anna H. Schuh, MD, of the department of oncology at the University of Oxford (England), and her coauthors noted that, while these guidelines apply to treatments available outside clinical trials, wherever possible patients with CLL should be treated within the clinical trial setting.

While recommending fludarabine, cyclophosphamide, and rituximab as first-line therapy, the guideline authors acknowledged that the combination of bendamustine and rituximab is an acceptable alternative for patients who could not take the triple therapy because of comorbidities such as advanced age, renal impairment, or issues with marrow capacity.

Similarly, less-fit patients could also be considered for chlorambucil-obinutuzumab or chlorambucil-ofatumumab combinations.

All patients diagnosed with CLL should be tested for TP53 deletions and mutations before each line of therapy, the guideline committee recommended. TP53 disruption makes chemoimmunotherapy ineffective because of either a deletion of chromosome 17p or a mutation in the TP53 gene. However, there is compelling evidence for the efficacy of ibrutinib in these patients, or idelalisib and rituximab for those with cardiac disease or receiving vitamin K antagonists.

With respect to maintenance therapy, the guidelines noted that this was not routinely recommended in CLL as “it is unclear to what extent the progression-free survival benefit is offset by long-term toxicity.”

Patients who are refractory to chemoimmunotherapy, who have relapsed, or who cannot be retreated with chemoimmunotherapy should be treated with idelalisib with rituximab or ibrutinib monotherapy, the guidelines suggested.

“Deciding whether ibrutinib or idelalisib with rituximab is most appropriate for an individual patient depends on a range of factors, including toxicity profile and convenience of delivery,” the authors wrote. However, they noted that the value of adding bendamustine to either option was unclear as research had not shown significant, associated gains in median progression-free survival.

Allogeneic stem cell transplantation should be considered as a treatment option for patients who have either failed chemotherapy, have a TP53 disruption and have not responded to B-cell receptor signaling pathway inhibitors such as ibrutinib, or have a Richter transformation.

The guidelines also addressed the issue of autoimmune cytopenias, which occur in 5%-10% of patients with CLL and can actually precede the diagnosis of CLL in about 9% of cases.

In patients where autoimmune cytopenia is the dominant clinical feature, they should be treated with corticosteroids, intravenous immunoglobulin, or rituximab. However, for patients where the cytopenia is triggered by CLL therapy, the guidelines recommended halting treatment and beginning immunosuppression.

The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.

SOURCE: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.

For adult patients with HIV, earlier treatment results in faster and more likely virologic suppression along with greater linkage to care, according to the 2018 Recommendations of the International Antiviral Society-USA (IAS-USA).

The updated treatment and prevention guidelines also have outlined drug selection, including three-drug therapy (usually as a single-tablet combination) and two-drug switch therapy, as well as discouragement of cash incentives for treatment. The guidelines, written by Michael S. Saag, MD, of the University of Alabama at Birmingham and his coauthors, were published in JAMA.

Since the previous IAS-USA guidelines were published in 2016 (JAMA. 2016;316(2):191-210), multiple studies have investigated the importance of timely antiretroviral therapy (ART). In one study, patients with HIV began ART within 24 hours of diagnosis. These patients achieved virologic suppression (fewer than 200 HIV RNA copies/mL) quicker than patients treated according to previous guidelines (medians, 1.8 months vs. 4.3 months; P = .0001). Another study found that patients who began ART immediately were more likely to achieve viral suppression at 12 months (50% vs. 34%; P = .007) and become linked to care at 3 months (68% vs. 43%). As such, the updated guidelines recommended that ART should be started as soon as possible (even without supporting laboratory results). Exceptions were maintained for patients not ready to start therapy and those at risk for immune reconstitution syndrome.

With regard to initial treatment selection, three-drug therapy is recommended, incorporating an integrase single-strand transfer inhibitor (InSTI) with 2 nucleoside reverse transcriptase inhibitors.

Single-tablet formulations are effective, well tolerated, and promote medication adherence. Dolutegravir is not recommended in women who are pregnant or may become pregnant because it may increase the risk of neural tube defects. It is unclear whether other InSTIs pose similar risks. Although two-drug regimens are not recommended for initial therapy, they may be considered as switch therapy to reduce cost and complications.

The 2018 guidelines have discouraged cash incentives for ART adherence because such programs have proven ineffective. Conversely, noncash incentives are likely to be beneficial. Further recommendations to improve outcomes were wide ranging and included identification of patients subject to food scarcity or psychiatric disorders. For the latter, chronic depression has been associated with worse outcomes – including a two-fold mortality risk – and so appropriate treatment is recommended.

The researchers concluded with a brief review of future directions for HIV treatment and prevention. Long-acting injectable and oral antiretrovirals are under investigation, along with implantable and nanoparticle therapies.

“Clinicians who care for patients with HIV have a major role in advocating for programs and their patients at the local, national, and international levels,” the authors wrote. “Advocacy should go beyond access to ART and include access to mental health and substance abuse services, as well as efforts to end policies such as HIV criminalization that impede the ability to provide evidence-based care and prevention services.”

The authors reported support from Gilead, ViiV, Merck, and other sources. The current guidelines were funded by IAS-USA.

SOURCE: Saag MS et al. JAMA. 2018;320[4]:379-96.

For adult patients with HIV, earlier treatment results in faster and more likely virologic suppression along with greater linkage to care, according to the 2018 Recommendations of the International Antiviral Society-USA (IAS-USA).

The updated treatment and prevention guidelines also have outlined drug selection, including three-drug therapy (usually as a single-tablet combination) and two-drug switch therapy, as well as discouragement of cash incentives for treatment. The guidelines, written by Michael S. Saag, MD, of the University of Alabama at Birmingham and his coauthors, were published in JAMA.

Since the previous IAS-USA guidelines were published in 2016 (JAMA. 2016;316(2):191-210), multiple studies have investigated the importance of timely antiretroviral therapy (ART). In one study, patients with HIV began ART within 24 hours of diagnosis. These patients achieved virologic suppression (fewer than 200 HIV RNA copies/mL) quicker than patients treated according to previous guidelines (medians, 1.8 months vs. 4.3 months; P = .0001). Another study found that patients who began ART immediately were more likely to achieve viral suppression at 12 months (50% vs. 34%; P = .007) and become linked to care at 3 months (68% vs. 43%). As such, the updated guidelines recommended that ART should be started as soon as possible (even without supporting laboratory results). Exceptions were maintained for patients not ready to start therapy and those at risk for immune reconstitution syndrome.

With regard to initial treatment selection, three-drug therapy is recommended, incorporating an integrase single-strand transfer inhibitor (InSTI) with 2 nucleoside reverse transcriptase inhibitors.

Single-tablet formulations are effective, well tolerated, and promote medication adherence. Dolutegravir is not recommended in women who are pregnant or may become pregnant because it may increase the risk of neural tube defects. It is unclear whether other InSTIs pose similar risks. Although two-drug regimens are not recommended for initial therapy, they may be considered as switch therapy to reduce cost and complications.

The 2018 guidelines have discouraged cash incentives for ART adherence because such programs have proven ineffective. Conversely, noncash incentives are likely to be beneficial. Further recommendations to improve outcomes were wide ranging and included identification of patients subject to food scarcity or psychiatric disorders. For the latter, chronic depression has been associated with worse outcomes – including a two-fold mortality risk – and so appropriate treatment is recommended.

The researchers concluded with a brief review of future directions for HIV treatment and prevention. Long-acting injectable and oral antiretrovirals are under investigation, along with implantable and nanoparticle therapies.

“Clinicians who care for patients with HIV have a major role in advocating for programs and their patients at the local, national, and international levels,” the authors wrote. “Advocacy should go beyond access to ART and include access to mental health and substance abuse services, as well as efforts to end policies such as HIV criminalization that impede the ability to provide evidence-based care and prevention services.”

The authors reported support from Gilead, ViiV, Merck, and other sources. The current guidelines were funded by IAS-USA.

SOURCE: Saag MS et al. JAMA. 2018;320[4]:379-96.

For adult patients with HIV, earlier treatment results in faster and more likely virologic suppression along with greater linkage to care, according to the 2018 Recommendations of the International Antiviral Society-USA (IAS-USA).

The updated treatment and prevention guidelines also have outlined drug selection, including three-drug therapy (usually as a single-tablet combination) and two-drug switch therapy, as well as discouragement of cash incentives for treatment. The guidelines, written by Michael S. Saag, MD, of the University of Alabama at Birmingham and his coauthors, were published in JAMA.

Since the previous IAS-USA guidelines were published in 2016 (JAMA. 2016;316(2):191-210), multiple studies have investigated the importance of timely antiretroviral therapy (ART). In one study, patients with HIV began ART within 24 hours of diagnosis. These patients achieved virologic suppression (fewer than 200 HIV RNA copies/mL) quicker than patients treated according to previous guidelines (medians, 1.8 months vs. 4.3 months; P = .0001). Another study found that patients who began ART immediately were more likely to achieve viral suppression at 12 months (50% vs. 34%; P = .007) and become linked to care at 3 months (68% vs. 43%). As such, the updated guidelines recommended that ART should be started as soon as possible (even without supporting laboratory results). Exceptions were maintained for patients not ready to start therapy and those at risk for immune reconstitution syndrome.

With regard to initial treatment selection, three-drug therapy is recommended, incorporating an integrase single-strand transfer inhibitor (InSTI) with 2 nucleoside reverse transcriptase inhibitors.

Single-tablet formulations are effective, well tolerated, and promote medication adherence. Dolutegravir is not recommended in women who are pregnant or may become pregnant because it may increase the risk of neural tube defects. It is unclear whether other InSTIs pose similar risks. Although two-drug regimens are not recommended for initial therapy, they may be considered as switch therapy to reduce cost and complications.

The 2018 guidelines have discouraged cash incentives for ART adherence because such programs have proven ineffective. Conversely, noncash incentives are likely to be beneficial. Further recommendations to improve outcomes were wide ranging and included identification of patients subject to food scarcity or psychiatric disorders. For the latter, chronic depression has been associated with worse outcomes – including a two-fold mortality risk – and so appropriate treatment is recommended.

The researchers concluded with a brief review of future directions for HIV treatment and prevention. Long-acting injectable and oral antiretrovirals are under investigation, along with implantable and nanoparticle therapies.

“Clinicians who care for patients with HIV have a major role in advocating for programs and their patients at the local, national, and international levels,” the authors wrote. “Advocacy should go beyond access to ART and include access to mental health and substance abuse services, as well as efforts to end policies such as HIV criminalization that impede the ability to provide evidence-based care and prevention services.”

The authors reported support from Gilead, ViiV, Merck, and other sources. The current guidelines were funded by IAS-USA.

SOURCE: Saag MS et al. JAMA. 2018;320[4]:379-96.

Transcatheter aortic valve replacement has entered a new stage of development, and so needed a tweaked set of standards for how existing programs operate and what new program need to open, said a panel of experts formed by the four U.S. societies with the closest links to this procedure.

U.S. transcatheter aortic valve replacement (TAVR) programs have “matured as a therapeutic option” since its commercial U.S. introduction in 2012, said a revised statement of operator and institutional recommendations and requirements issued on July 18 by the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. A writing panel formed by these four groups prepared the revision, published online in the Journal of the American College of Cardiology on July 18, to replace the first set of recommendations for running U.S. TAVR programs that came out in 2012 (J Am Coll Cardiol. 2012 May 29;59[22]:2028-42).

“The main thrust is to ensure and allow for the metrics of quality TAVR,” said Joseph E. Bavaria, MD, cochair of the writing panel and professor of surgery and codirector of the transcatheter valve program at the University of Pennsylvania in Philadelphia. “We’re trying to force continuous quality improvement across U.S. TAVR teams,” Dr. Bavaria explained in an interview.

The key to this change will be the data collected on every U.S. TAVR patient in the Transcatheter Valve Therapy registry maintained by the American College of Cardiology and the Society of Thoracic Surgeons, which now has data on more than 120,000 patients who have undergone TAVR at what are now 582 active U.S. TAVR programs, noted Carl L. Tommaso, MD, an interventional cardiologist with NorthShore Medical Group in Bannockburn, Ill., and cochair of the writing panel. “You need to do risk adjustment to measure quality of care,” and the robust database that now exists has begun to make this possible, said Dr. Tommaso, who neither performs TAVR procedures nor participates on a TAVR team. Statistical analyses based on this substantial and always-expanding database of TAVR patients now allows for risk-adjusted assessment of in hospital and 30-day mortality, and risk-adjusted evaluation of 1-year mortality and quality-of-life outcomes are expected within the next couple of years.

“We’re still not yet at the point of having good, risk-adjusted models” for all these measures, but our hope is that in the next 2-7 years we can move completely to quality measures, as has already been done for percutaneous coronary interventions” and away from procedure volume, which currently serves as a surrogate marker for a TAVR program’s competence.

The new document continues to call for TAVR programs to average at least 50 TAVR procedures a year or at least 100 every 2 years, but primarily to insure that each TAVR program can generate enough data about its performance to produce statistically reliable numbers.

“The volume floors are only there because you can’t measure quality without volume,” said Dr. Bavaria. “It’s impossible to measure quality without a certain procedure volume.”

Dr. Bavaria stressed, however, that the goal of the new document is not to limit TAVR programs based on their procedure volume, especially because another goal of the document is to ensure reasonable geographic access to TAVR for U.S. patients. “This document does not advocate for any program to shut down,” he declared. On top of that, “we have no problem with new programs,” although the document noted that “the major threat to low volume sites growing and achieving higher levels of experience is the opening of additional sites in the same geographic region.”

In 2017, 204 of the 525 sites (39%) performing TAVR at that time were performing fewer than 50 procedures annually, the document said, but added that many TAVR centers now operate in what are predominantly rural regions “and it is important that they remain active if they can document acceptable quality even if they should fall below volume thresholds to maintain patient access to care.”

Dr. Tommaso said that perhaps a TAVR center in Alaska, for example, might not meet the 50 cases/year standard, “but I don’t think anyone would worry if the volume was low because we’re serving patients in Alaska.” Currently, 84% of TAVR centers that have been operating for more than 2 years meet the 50 procedures/year threshold, he added. And TAVR centers now operate in 49 of the 50 states, with only Wyoming lacking a TAVR facility within its borders. Despite this, use of TAVR among Wyoming residents is comparable to the rate in Illinois, Dr. Bavaria said.

Both cochairs also highlighted that, with TAVR now approved for patients at moderate risk for aortic-valve surgery, the number of patients who are TAVR candidates has grown, and it’s possible that pending trial results will soon broaden TAVR’s availability to low-risk patients, a step that would greatly further expand the potential patient pool for the procedure.

The revised recommendations and requirements will make it “a little easier to start a new program, except now, for the first time, you need to start with an operator who is already experienced with TAVR,” noted Dr. Bavaria. “The TAVR technology is now mature enough that it’s inappropriate to have learning-curve mortality.” But aside from this the new standards lower the bar a bit for a center’s volume of percutaneous coronary interventions and surgical aortic valve replacements. The revision also maintains that an examination by and consultation with a single cardiac surgeon by a prospective TAVR patient is adequate, similar to the 2012 document, although the Center for Medicare & Medicaid Services mandated in its coverage decision that prospective TAVR patients consult with two cardiac surgeons, the so-called “two-surgeon rule.” If CMS eliminated the two-surgeon rule it would “streamline” the process that patients go through when being assessed for TAVR, Dr. Tommaso observed, and both he and Dr. Bavaria expressed hope that the new document might prompt CMS to reconsider this guidance.

“We felt that two surgeons weren’t needed,” but the document specifies that both the surgeon and the cardiologist whom a prospective patient consults before finalizing plans for the intervention should both be members of the multidisciplinary team that performs the procedure. Until now, these clinicians weren’t specified as necessarily members of the TAVR team, Dr. Bavaria said.

One additional new element in the revised document is specification of shared decision making as the mechanism patients should go through when considering TAVR relative to their other management options, Dr. Tommaso said.Dr. Bavaria and Dr. Tommaso had no disclosures.

[email protected]
 

SOURCE: Bavaria JE et al. JACC. 2018 Jul18. doi:10.1016/j.jacc.2018.07.002.
 

Transcatheter aortic valve replacement has entered a new stage of development, and so needed a tweaked set of standards for how existing programs operate and what new program need to open, said a panel of experts formed by the four U.S. societies with the closest links to this procedure.

U.S. transcatheter aortic valve replacement (TAVR) programs have “matured as a therapeutic option” since its commercial U.S. introduction in 2012, said a revised statement of operator and institutional recommendations and requirements issued on July 18 by the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. A writing panel formed by these four groups prepared the revision, published online in the Journal of the American College of Cardiology on July 18, to replace the first set of recommendations for running U.S. TAVR programs that came out in 2012 (J Am Coll Cardiol. 2012 May 29;59[22]:2028-42).

“The main thrust is to ensure and allow for the metrics of quality TAVR,” said Joseph E. Bavaria, MD, cochair of the writing panel and professor of surgery and codirector of the transcatheter valve program at the University of Pennsylvania in Philadelphia. “We’re trying to force continuous quality improvement across U.S. TAVR teams,” Dr. Bavaria explained in an interview.

The key to this change will be the data collected on every U.S. TAVR patient in the Transcatheter Valve Therapy registry maintained by the American College of Cardiology and the Society of Thoracic Surgeons, which now has data on more than 120,000 patients who have undergone TAVR at what are now 582 active U.S. TAVR programs, noted Carl L. Tommaso, MD, an interventional cardiologist with NorthShore Medical Group in Bannockburn, Ill., and cochair of the writing panel. “You need to do risk adjustment to measure quality of care,” and the robust database that now exists has begun to make this possible, said Dr. Tommaso, who neither performs TAVR procedures nor participates on a TAVR team. Statistical analyses based on this substantial and always-expanding database of TAVR patients now allows for risk-adjusted assessment of in hospital and 30-day mortality, and risk-adjusted evaluation of 1-year mortality and quality-of-life outcomes are expected within the next couple of years.

“We’re still not yet at the point of having good, risk-adjusted models” for all these measures, but our hope is that in the next 2-7 years we can move completely to quality measures, as has already been done for percutaneous coronary interventions” and away from procedure volume, which currently serves as a surrogate marker for a TAVR program’s competence.

The new document continues to call for TAVR programs to average at least 50 TAVR procedures a year or at least 100 every 2 years, but primarily to insure that each TAVR program can generate enough data about its performance to produce statistically reliable numbers.

“The volume floors are only there because you can’t measure quality without volume,” said Dr. Bavaria. “It’s impossible to measure quality without a certain procedure volume.”

Dr. Bavaria stressed, however, that the goal of the new document is not to limit TAVR programs based on their procedure volume, especially because another goal of the document is to ensure reasonable geographic access to TAVR for U.S. patients. “This document does not advocate for any program to shut down,” he declared. On top of that, “we have no problem with new programs,” although the document noted that “the major threat to low volume sites growing and achieving higher levels of experience is the opening of additional sites in the same geographic region.”

In 2017, 204 of the 525 sites (39%) performing TAVR at that time were performing fewer than 50 procedures annually, the document said, but added that many TAVR centers now operate in what are predominantly rural regions “and it is important that they remain active if they can document acceptable quality even if they should fall below volume thresholds to maintain patient access to care.”

Dr. Tommaso said that perhaps a TAVR center in Alaska, for example, might not meet the 50 cases/year standard, “but I don’t think anyone would worry if the volume was low because we’re serving patients in Alaska.” Currently, 84% of TAVR centers that have been operating for more than 2 years meet the 50 procedures/year threshold, he added. And TAVR centers now operate in 49 of the 50 states, with only Wyoming lacking a TAVR facility within its borders. Despite this, use of TAVR among Wyoming residents is comparable to the rate in Illinois, Dr. Bavaria said.

Both cochairs also highlighted that, with TAVR now approved for patients at moderate risk for aortic-valve surgery, the number of patients who are TAVR candidates has grown, and it’s possible that pending trial results will soon broaden TAVR’s availability to low-risk patients, a step that would greatly further expand the potential patient pool for the procedure.

The revised recommendations and requirements will make it “a little easier to start a new program, except now, for the first time, you need to start with an operator who is already experienced with TAVR,” noted Dr. Bavaria. “The TAVR technology is now mature enough that it’s inappropriate to have learning-curve mortality.” But aside from this the new standards lower the bar a bit for a center’s volume of percutaneous coronary interventions and surgical aortic valve replacements. The revision also maintains that an examination by and consultation with a single cardiac surgeon by a prospective TAVR patient is adequate, similar to the 2012 document, although the Center for Medicare & Medicaid Services mandated in its coverage decision that prospective TAVR patients consult with two cardiac surgeons, the so-called “two-surgeon rule.” If CMS eliminated the two-surgeon rule it would “streamline” the process that patients go through when being assessed for TAVR, Dr. Tommaso observed, and both he and Dr. Bavaria expressed hope that the new document might prompt CMS to reconsider this guidance.

“We felt that two surgeons weren’t needed,” but the document specifies that both the surgeon and the cardiologist whom a prospective patient consults before finalizing plans for the intervention should both be members of the multidisciplinary team that performs the procedure. Until now, these clinicians weren’t specified as necessarily members of the TAVR team, Dr. Bavaria said.

One additional new element in the revised document is specification of shared decision making as the mechanism patients should go through when considering TAVR relative to their other management options, Dr. Tommaso said.Dr. Bavaria and Dr. Tommaso had no disclosures.

[email protected]
 

SOURCE: Bavaria JE et al. JACC. 2018 Jul18. doi:10.1016/j.jacc.2018.07.002.
 

Transcatheter aortic valve replacement has entered a new stage of development, and so needed a tweaked set of standards for how existing programs operate and what new program need to open, said a panel of experts formed by the four U.S. societies with the closest links to this procedure.

U.S. transcatheter aortic valve replacement (TAVR) programs have “matured as a therapeutic option” since its commercial U.S. introduction in 2012, said a revised statement of operator and institutional recommendations and requirements issued on July 18 by the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. A writing panel formed by these four groups prepared the revision, published online in the Journal of the American College of Cardiology on July 18, to replace the first set of recommendations for running U.S. TAVR programs that came out in 2012 (J Am Coll Cardiol. 2012 May 29;59[22]:2028-42).

“The main thrust is to ensure and allow for the metrics of quality TAVR,” said Joseph E. Bavaria, MD, cochair of the writing panel and professor of surgery and codirector of the transcatheter valve program at the University of Pennsylvania in Philadelphia. “We’re trying to force continuous quality improvement across U.S. TAVR teams,” Dr. Bavaria explained in an interview.

The key to this change will be the data collected on every U.S. TAVR patient in the Transcatheter Valve Therapy registry maintained by the American College of Cardiology and the Society of Thoracic Surgeons, which now has data on more than 120,000 patients who have undergone TAVR at what are now 582 active U.S. TAVR programs, noted Carl L. Tommaso, MD, an interventional cardiologist with NorthShore Medical Group in Bannockburn, Ill., and cochair of the writing panel. “You need to do risk adjustment to measure quality of care,” and the robust database that now exists has begun to make this possible, said Dr. Tommaso, who neither performs TAVR procedures nor participates on a TAVR team. Statistical analyses based on this substantial and always-expanding database of TAVR patients now allows for risk-adjusted assessment of in hospital and 30-day mortality, and risk-adjusted evaluation of 1-year mortality and quality-of-life outcomes are expected within the next couple of years.

“We’re still not yet at the point of having good, risk-adjusted models” for all these measures, but our hope is that in the next 2-7 years we can move completely to quality measures, as has already been done for percutaneous coronary interventions” and away from procedure volume, which currently serves as a surrogate marker for a TAVR program’s competence.

The new document continues to call for TAVR programs to average at least 50 TAVR procedures a year or at least 100 every 2 years, but primarily to insure that each TAVR program can generate enough data about its performance to produce statistically reliable numbers.

“The volume floors are only there because you can’t measure quality without volume,” said Dr. Bavaria. “It’s impossible to measure quality without a certain procedure volume.”

Dr. Bavaria stressed, however, that the goal of the new document is not to limit TAVR programs based on their procedure volume, especially because another goal of the document is to ensure reasonable geographic access to TAVR for U.S. patients. “This document does not advocate for any program to shut down,” he declared. On top of that, “we have no problem with new programs,” although the document noted that “the major threat to low volume sites growing and achieving higher levels of experience is the opening of additional sites in the same geographic region.”

In 2017, 204 of the 525 sites (39%) performing TAVR at that time were performing fewer than 50 procedures annually, the document said, but added that many TAVR centers now operate in what are predominantly rural regions “and it is important that they remain active if they can document acceptable quality even if they should fall below volume thresholds to maintain patient access to care.”

Dr. Tommaso said that perhaps a TAVR center in Alaska, for example, might not meet the 50 cases/year standard, “but I don’t think anyone would worry if the volume was low because we’re serving patients in Alaska.” Currently, 84% of TAVR centers that have been operating for more than 2 years meet the 50 procedures/year threshold, he added. And TAVR centers now operate in 49 of the 50 states, with only Wyoming lacking a TAVR facility within its borders. Despite this, use of TAVR among Wyoming residents is comparable to the rate in Illinois, Dr. Bavaria said.

Both cochairs also highlighted that, with TAVR now approved for patients at moderate risk for aortic-valve surgery, the number of patients who are TAVR candidates has grown, and it’s possible that pending trial results will soon broaden TAVR’s availability to low-risk patients, a step that would greatly further expand the potential patient pool for the procedure.

The revised recommendations and requirements will make it “a little easier to start a new program, except now, for the first time, you need to start with an operator who is already experienced with TAVR,” noted Dr. Bavaria. “The TAVR technology is now mature enough that it’s inappropriate to have learning-curve mortality.” But aside from this the new standards lower the bar a bit for a center’s volume of percutaneous coronary interventions and surgical aortic valve replacements. The revision also maintains that an examination by and consultation with a single cardiac surgeon by a prospective TAVR patient is adequate, similar to the 2012 document, although the Center for Medicare & Medicaid Services mandated in its coverage decision that prospective TAVR patients consult with two cardiac surgeons, the so-called “two-surgeon rule.” If CMS eliminated the two-surgeon rule it would “streamline” the process that patients go through when being assessed for TAVR, Dr. Tommaso observed, and both he and Dr. Bavaria expressed hope that the new document might prompt CMS to reconsider this guidance.

“We felt that two surgeons weren’t needed,” but the document specifies that both the surgeon and the cardiologist whom a prospective patient consults before finalizing plans for the intervention should both be members of the multidisciplinary team that performs the procedure. Until now, these clinicians weren’t specified as necessarily members of the TAVR team, Dr. Bavaria said.

One additional new element in the revised document is specification of shared decision making as the mechanism patients should go through when considering TAVR relative to their other management options, Dr. Tommaso said.Dr. Bavaria and Dr. Tommaso had no disclosures.

[email protected]
 

SOURCE: Bavaria JE et al. JACC. 2018 Jul18. doi:10.1016/j.jacc.2018.07.002.
 

Rituximab should be included in first-line chemotherapy when treating mantle cell lymphoma, according to a new management guideline from the British Society for Haematology.

The best outcome data is for the R-CHOP regimen (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone) followed by maintenance treatment with rituximab, wrote Pamela McKay, MD, of Beatson West of Scotland Cancer Centre in Glasgow, and her colleagues. The report was published in the British Journal of Haematology. But the combination of rituximab and bendamustine is also effective and a more favorable safety profile, according to the guideline. Single agent rituximab is not recommended.

At relapse, the guideline calls on physicians to take an individualized approach based on age, comorbidities, performance status, and response to prior therapy. Some options to consider include ibrutinib as a single agent or rituximab plus chemotherapy. The authors cautioned that there is little evidence to support maintenance rituximab after relapse treatment.

The guideline also explores the role of autologous stem cell transplantation (ASCT) and allogeneic SCT (alloSCT). The authors recommend that ASCT be considered as consolidation of first-line therapy for patients who are fit for intensive therapy. AlloSCT is a viable option in second remission among fit patients who have an appropriate donor and it may also be effective as a rescue therapy for patients who relapse after ASCT. But alloSCT is appropriate only as a first-line therapy for high-risk patients and is best used as part of a clinical trial, according to the recommendations.

The British Society of Haematology previously issued guidance on mantle cell lymphoma in 2012, but the updated document includes new drug therapeutic options and transplant data. The guideline includes a therapeutic algorithm to assist physicians in choosing first-line therapy, options after first relapse, and management in the case of higher relapse.

The guideline authors reported having no conflicts of interest.

[email protected]

SOURCE: McKay P et al. Br J Haematol. 2018 Jul;182(1):46-62.

Rituximab should be included in first-line chemotherapy when treating mantle cell lymphoma, according to a new management guideline from the British Society for Haematology.

The best outcome data is for the R-CHOP regimen (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone) followed by maintenance treatment with rituximab, wrote Pamela McKay, MD, of Beatson West of Scotland Cancer Centre in Glasgow, and her colleagues. The report was published in the British Journal of Haematology. But the combination of rituximab and bendamustine is also effective and a more favorable safety profile, according to the guideline. Single agent rituximab is not recommended.

At relapse, the guideline calls on physicians to take an individualized approach based on age, comorbidities, performance status, and response to prior therapy. Some options to consider include ibrutinib as a single agent or rituximab plus chemotherapy. The authors cautioned that there is little evidence to support maintenance rituximab after relapse treatment.

The guideline also explores the role of autologous stem cell transplantation (ASCT) and allogeneic SCT (alloSCT). The authors recommend that ASCT be considered as consolidation of first-line therapy for patients who are fit for intensive therapy. AlloSCT is a viable option in second remission among fit patients who have an appropriate donor and it may also be effective as a rescue therapy for patients who relapse after ASCT. But alloSCT is appropriate only as a first-line therapy for high-risk patients and is best used as part of a clinical trial, according to the recommendations.

The British Society of Haematology previously issued guidance on mantle cell lymphoma in 2012, but the updated document includes new drug therapeutic options and transplant data. The guideline includes a therapeutic algorithm to assist physicians in choosing first-line therapy, options after first relapse, and management in the case of higher relapse.

The guideline authors reported having no conflicts of interest.

[email protected]

SOURCE: McKay P et al. Br J Haematol. 2018 Jul;182(1):46-62.

Rituximab should be included in first-line chemotherapy when treating mantle cell lymphoma, according to a new management guideline from the British Society for Haematology.

The best outcome data is for the R-CHOP regimen (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone) followed by maintenance treatment with rituximab, wrote Pamela McKay, MD, of Beatson West of Scotland Cancer Centre in Glasgow, and her colleagues. The report was published in the British Journal of Haematology. But the combination of rituximab and bendamustine is also effective and a more favorable safety profile, according to the guideline. Single agent rituximab is not recommended.

At relapse, the guideline calls on physicians to take an individualized approach based on age, comorbidities, performance status, and response to prior therapy. Some options to consider include ibrutinib as a single agent or rituximab plus chemotherapy. The authors cautioned that there is little evidence to support maintenance rituximab after relapse treatment.

The guideline also explores the role of autologous stem cell transplantation (ASCT) and allogeneic SCT (alloSCT). The authors recommend that ASCT be considered as consolidation of first-line therapy for patients who are fit for intensive therapy. AlloSCT is a viable option in second remission among fit patients who have an appropriate donor and it may also be effective as a rescue therapy for patients who relapse after ASCT. But alloSCT is appropriate only as a first-line therapy for high-risk patients and is best used as part of a clinical trial, according to the recommendations.

The British Society of Haematology previously issued guidance on mantle cell lymphoma in 2012, but the updated document includes new drug therapeutic options and transplant data. The guideline includes a therapeutic algorithm to assist physicians in choosing first-line therapy, options after first relapse, and management in the case of higher relapse.

The guideline authors reported having no conflicts of interest.

[email protected]

SOURCE: McKay P et al. Br J Haematol. 2018 Jul;182(1):46-62.

The Agency for Healthcare Research and Quality has announced that after July 16, 2018, its National Guideline Clearinghouse (NGC) website (guideline.gov) will no longer be available because its federal funding will be discontinued. According to the NGC website, its mission is to provide “an accessible mechanism for obtaining objective, detailed information on clinical practice guidelines and to further their dissemination, implementation, and use.”

Its services, all free to use, included providing summaries of each guideline, side-by-side comparisons of two or more guidelines, and syntheses of guidelines covering similar topics, highlighting areas of similarity and difference.

Update, July 17, 2018: Now that the guidelines are no longer available on the government site, ECRI Institute, the independent nonprofit that developed and maintained the National Guidelines Clearinghouse since its inception 20 years ago, “announced plans to continue providing this critical service to the healthcare community.” The ECRI Institute stated that they will launch an interim website this Fall “with many additional features planned for the near future.” Participating guideline developers will be able to access and contribute to the website free of charge, according to the company, while others will be charged a fee. In addition, as a temporary stop-gap, Fred Trotter, founder and CTO of CareSet Systems, a Medicare data use site, voluntarily cloned the complete guidelines before the government site shut down and made them available for public use here: https://github.com/CareSet/AHRQ_search_clone.

[email protected]

The Agency for Healthcare Research and Quality has announced that after July 16, 2018, its National Guideline Clearinghouse (NGC) website (guideline.gov) will no longer be available because its federal funding will be discontinued. According to the NGC website, its mission is to provide “an accessible mechanism for obtaining objective, detailed information on clinical practice guidelines and to further their dissemination, implementation, and use.”

Its services, all free to use, included providing summaries of each guideline, side-by-side comparisons of two or more guidelines, and syntheses of guidelines covering similar topics, highlighting areas of similarity and difference.

Update, July 17, 2018: Now that the guidelines are no longer available on the government site, ECRI Institute, the independent nonprofit that developed and maintained the National Guidelines Clearinghouse since its inception 20 years ago, “announced plans to continue providing this critical service to the healthcare community.” The ECRI Institute stated that they will launch an interim website this Fall “with many additional features planned for the near future.” Participating guideline developers will be able to access and contribute to the website free of charge, according to the company, while others will be charged a fee. In addition, as a temporary stop-gap, Fred Trotter, founder and CTO of CareSet Systems, a Medicare data use site, voluntarily cloned the complete guidelines before the government site shut down and made them available for public use here: https://github.com/CareSet/AHRQ_search_clone.

[email protected]

The Agency for Healthcare Research and Quality has announced that after July 16, 2018, its National Guideline Clearinghouse (NGC) website (guideline.gov) will no longer be available because its federal funding will be discontinued. According to the NGC website, its mission is to provide “an accessible mechanism for obtaining objective, detailed information on clinical practice guidelines and to further their dissemination, implementation, and use.”

Its services, all free to use, included providing summaries of each guideline, side-by-side comparisons of two or more guidelines, and syntheses of guidelines covering similar topics, highlighting areas of similarity and difference.

Update, July 17, 2018: Now that the guidelines are no longer available on the government site, ECRI Institute, the independent nonprofit that developed and maintained the National Guidelines Clearinghouse since its inception 20 years ago, “announced plans to continue providing this critical service to the healthcare community.” The ECRI Institute stated that they will launch an interim website this Fall “with many additional features planned for the near future.” Participating guideline developers will be able to access and contribute to the website free of charge, according to the company, while others will be charged a fee. In addition, as a temporary stop-gap, Fred Trotter, founder and CTO of CareSet Systems, a Medicare data use site, voluntarily cloned the complete guidelines before the government site shut down and made them available for public use here: https://github.com/CareSet/AHRQ_search_clone.

[email protected]

A new analysis estimates that adopting the 2017 ACC/AHA hypertension guidelines would add 15.6 million Americans to the ranks of the hypertensives, and half of those would be candidates for treatment.

Similar increases would occur in other countries, according to study authors, who analyzed two large datasets from the United States and China.

That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, meaning more than half of people aged 45-75 years in both countries would be classified as having hypertension, according to the researchers, led by Harlan M. Krumholz, MD, of the Center for Outcomes Research and Evaluation at Yale–New Haven (Conn.) Hospital and the section of cardiovascular medicine at Yale

An additional 7.5 million Americans would be recommended for treatment under the new lower treatment thresholds, with a correspondingly large increase in the Chinese population, according to results published in the BMJ.

The guideline changes are “not firmly rooted in evidence” and could have health policy implications that include strain on public health programs, Dr. Krumholz and his colleagues said in their report on the study.

“The change occurs at a time when both countries have substantial numbers of people who are not aware of having hypertension, and who have hypertension that is not controlled, even according to the previous standards,” they wrote.

The analysis by Dr. Krumholz and his colleagues was based on the two most recent cycles of the U.S. National Health and Nutrition Examination Survey (NHANES), representing 2013-2014 and 2015-2016 periods, as well as the China Health and Retirement Longitudinal Study (CHARLS) in 2011-2012.

Under the new ACC/AHA guidelines, they found, 70.1 million Americans aged 45-65 years would be classified as hypertensive, representing 63% of that age group. That’s a 27% relative increase over the 55.3 million individuals, or 49.7%, with hypertension as defined in the JNC-8 guidelines.

In addition, 15.6 million persons would be classified as eligible for treatment but not receiving it, up from 8.1 million under the JNC-8 guidance.

Previous estimates projected a far greater jump in new hypertension classifications, including one that used data from the National Health and Nutrition Examination Survey, antihypertensive clinical trials, and population-based cohort studies. That study estimated that 31 million people would newly carry the label (JAMA Cardiol. 2018 May 23; doi: 10.1001/jamacardio.2018.1240.)

In the current analysis, in China, 267 million aged 45-65 years (55% of that age group) would be classified with hypertension under the ACC/AHA guidelines, a relative increase of 45% over the JNC-8 guidelines, while the number of candidates for treatment would be 129 million, up from 74.5 million under the earlier guidelines.

Dr. Krumholz noted that the ACC/AHA guideline changes were prompted by results from the SPRINT trial. However, the improvements in outcomes seen in SPRINT, which included patients at high risk for cardiovascular events but without diabetes, have not been observed in individuals at low or intermediate risk, or in those with diabetes, they said.

“Expanding the pool of patients who merit treatment to include those at low risk could potentially render public health programs less efficient and viable,” they wrote in a discussion of health policy implications.

The new guidelines also put millions at risk of the “psychological morbidity” that comes with the label of a chronic disease, and at risk for more adverse events caused by inappropriate use of drug therapy, they added.

Dr. Krumholz reported research agreements from Medtronic and from Johnson and Johnson (Janssen) through Yale University, and a grant from the Food and Drug Administration and Medtronic. He reported other disclosures related to UnitedHealth, the IBM Watson Health Life Sciences Board, Element Science, Aetna, and Hugo, a personal health information platform he founded. First author Rohan Khera, MD, reported support from the National Institutes of Health.
 

SOURCE: Khera R et al. BMJ. 2018 Jul 11;362:k2357


This article was updated 7/19/18.

A new analysis estimates that adopting the 2017 ACC/AHA hypertension guidelines would add 15.6 million Americans to the ranks of the hypertensives, and half of those would be candidates for treatment.

Similar increases would occur in other countries, according to study authors, who analyzed two large datasets from the United States and China.

That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, meaning more than half of people aged 45-75 years in both countries would be classified as having hypertension, according to the researchers, led by Harlan M. Krumholz, MD, of the Center for Outcomes Research and Evaluation at Yale–New Haven (Conn.) Hospital and the section of cardiovascular medicine at Yale

An additional 7.5 million Americans would be recommended for treatment under the new lower treatment thresholds, with a correspondingly large increase in the Chinese population, according to results published in the BMJ.

The guideline changes are “not firmly rooted in evidence” and could have health policy implications that include strain on public health programs, Dr. Krumholz and his colleagues said in their report on the study.

“The change occurs at a time when both countries have substantial numbers of people who are not aware of having hypertension, and who have hypertension that is not controlled, even according to the previous standards,” they wrote.

The analysis by Dr. Krumholz and his colleagues was based on the two most recent cycles of the U.S. National Health and Nutrition Examination Survey (NHANES), representing 2013-2014 and 2015-2016 periods, as well as the China Health and Retirement Longitudinal Study (CHARLS) in 2011-2012.

Under the new ACC/AHA guidelines, they found, 70.1 million Americans aged 45-65 years would be classified as hypertensive, representing 63% of that age group. That’s a 27% relative increase over the 55.3 million individuals, or 49.7%, with hypertension as defined in the JNC-8 guidelines.

In addition, 15.6 million persons would be classified as eligible for treatment but not receiving it, up from 8.1 million under the JNC-8 guidance.

Previous estimates projected a far greater jump in new hypertension classifications, including one that used data from the National Health and Nutrition Examination Survey, antihypertensive clinical trials, and population-based cohort studies. That study estimated that 31 million people would newly carry the label (JAMA Cardiol. 2018 May 23; doi: 10.1001/jamacardio.2018.1240.)

In the current analysis, in China, 267 million aged 45-65 years (55% of that age group) would be classified with hypertension under the ACC/AHA guidelines, a relative increase of 45% over the JNC-8 guidelines, while the number of candidates for treatment would be 129 million, up from 74.5 million under the earlier guidelines.

Dr. Krumholz noted that the ACC/AHA guideline changes were prompted by results from the SPRINT trial. However, the improvements in outcomes seen in SPRINT, which included patients at high risk for cardiovascular events but without diabetes, have not been observed in individuals at low or intermediate risk, or in those with diabetes, they said.

“Expanding the pool of patients who merit treatment to include those at low risk could potentially render public health programs less efficient and viable,” they wrote in a discussion of health policy implications.

The new guidelines also put millions at risk of the “psychological morbidity” that comes with the label of a chronic disease, and at risk for more adverse events caused by inappropriate use of drug therapy, they added.

Dr. Krumholz reported research agreements from Medtronic and from Johnson and Johnson (Janssen) through Yale University, and a grant from the Food and Drug Administration and Medtronic. He reported other disclosures related to UnitedHealth, the IBM Watson Health Life Sciences Board, Element Science, Aetna, and Hugo, a personal health information platform he founded. First author Rohan Khera, MD, reported support from the National Institutes of Health.
 

SOURCE: Khera R et al. BMJ. 2018 Jul 11;362:k2357


This article was updated 7/19/18.

A new analysis estimates that adopting the 2017 ACC/AHA hypertension guidelines would add 15.6 million Americans to the ranks of the hypertensives, and half of those would be candidates for treatment.

Similar increases would occur in other countries, according to study authors, who analyzed two large datasets from the United States and China.

That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, meaning more than half of people aged 45-75 years in both countries would be classified as having hypertension, according to the researchers, led by Harlan M. Krumholz, MD, of the Center for Outcomes Research and Evaluation at Yale–New Haven (Conn.) Hospital and the section of cardiovascular medicine at Yale

An additional 7.5 million Americans would be recommended for treatment under the new lower treatment thresholds, with a correspondingly large increase in the Chinese population, according to results published in the BMJ.

The guideline changes are “not firmly rooted in evidence” and could have health policy implications that include strain on public health programs, Dr. Krumholz and his colleagues said in their report on the study.

“The change occurs at a time when both countries have substantial numbers of people who are not aware of having hypertension, and who have hypertension that is not controlled, even according to the previous standards,” they wrote.

The analysis by Dr. Krumholz and his colleagues was based on the two most recent cycles of the U.S. National Health and Nutrition Examination Survey (NHANES), representing 2013-2014 and 2015-2016 periods, as well as the China Health and Retirement Longitudinal Study (CHARLS) in 2011-2012.

Under the new ACC/AHA guidelines, they found, 70.1 million Americans aged 45-65 years would be classified as hypertensive, representing 63% of that age group. That’s a 27% relative increase over the 55.3 million individuals, or 49.7%, with hypertension as defined in the JNC-8 guidelines.

In addition, 15.6 million persons would be classified as eligible for treatment but not receiving it, up from 8.1 million under the JNC-8 guidance.

Previous estimates projected a far greater jump in new hypertension classifications, including one that used data from the National Health and Nutrition Examination Survey, antihypertensive clinical trials, and population-based cohort studies. That study estimated that 31 million people would newly carry the label (JAMA Cardiol. 2018 May 23; doi: 10.1001/jamacardio.2018.1240.)

In the current analysis, in China, 267 million aged 45-65 years (55% of that age group) would be classified with hypertension under the ACC/AHA guidelines, a relative increase of 45% over the JNC-8 guidelines, while the number of candidates for treatment would be 129 million, up from 74.5 million under the earlier guidelines.

Dr. Krumholz noted that the ACC/AHA guideline changes were prompted by results from the SPRINT trial. However, the improvements in outcomes seen in SPRINT, which included patients at high risk for cardiovascular events but without diabetes, have not been observed in individuals at low or intermediate risk, or in those with diabetes, they said.

“Expanding the pool of patients who merit treatment to include those at low risk could potentially render public health programs less efficient and viable,” they wrote in a discussion of health policy implications.

The new guidelines also put millions at risk of the “psychological morbidity” that comes with the label of a chronic disease, and at risk for more adverse events caused by inappropriate use of drug therapy, they added.

Dr. Krumholz reported research agreements from Medtronic and from Johnson and Johnson (Janssen) through Yale University, and a grant from the Food and Drug Administration and Medtronic. He reported other disclosures related to UnitedHealth, the IBM Watson Health Life Sciences Board, Element Science, Aetna, and Hugo, a personal health information platform he founded. First author Rohan Khera, MD, reported support from the National Institutes of Health.
 

SOURCE: Khera R et al. BMJ. 2018 Jul 11;362:k2357


This article was updated 7/19/18.

AMSTERDAM – The first recommendations from a rheumatology society for managing patients with Sjögren’s syndrome are nearing finalization by a EULAR task force, and they divide the treatment targets into sicca syndrome and systemic manifestations of the disease.

“In Sjögren’s, we always have two subtypes of patients: those who have sicca syndrome only, and those with sicca syndrome plus systemic disease,” explained Soledad Retamozo, MD, who presented the current version of the recommendations at the European Congress of Rheumatology. “We wanted to highlight that there are two types of patients,” said Dr. Retamozo, a rheumatologist at the University of Córdoba (Argentina). “It’s hard to treat patients with sicca syndrome plus fatigue and pain because there is no high-level evidence on how to do this; all we have is expert opinion,” Dr. Retamozo said in an interview.

Mitchel L. Zoler/MDedge News

In fact, roughly half of the recommendations have no supporting evidence base, as presented by Dr. Retamozo. That starts with all three general recommendations she presented:

• Patients with Sjögren’s should be managed at a center of expertise using a multidisciplinary approach, which she said should include ophthalmologists and dentists to help address the mouth and ocular manifestations of sicca syndrome.

• Patients with sicca syndrome should receive symptomatic relief with topical treatments.

• Systemic treatments – glucocorticoids, immunosuppressants, and biologicals – can be considered for patients with active systemic disease.

The statement’s specific recommendations start with managing oral dryness, an intervention that should begin by measuring salivary gland (SG) dysfunction. The document next recommends nonpharmacologic interventions for mild SG dysfunction, pharmacological stimulation for moderate SG dysfunction, and a saliva substitute for severe SG dysfunction. All three recommendations are evidence based, relying on results from either randomized trials or controlled studies.

The second target for topical treatments is ocular dryness, which starts with artificial tears, or ocular gels or ointments, recommendations based on randomized trials. Refractory or severe ocular dryness should receive eye drops that contain a nonsteroidal anti-inflammatory drug or a glucocorticoid, based on controlled study results, or autologous serum eye drops, a strategy tested in a randomized trial.

The recommendations then shift to dealing with systemic manifestations, starting with fatigue and pain, offering the expert recommendation to evaluate the contribution of comorbid diseases and assess their severity with tools such as the Eular Sjögren’s Syndrome Patient-Reported Index (ESSPRI) (Ann Rheum Dis. 2011 June;70[6]:968-72), the Profile of Fatigue, and the Brief Pain Inventory.

Using evidence from randomized trials, the recommendations tell clinicians to consider treatment with analgesics or pain-modifying agents for musculoskeletal pain by weighing the potential benefits and adverse effects from this treatment.

For other forms of systemic disease, the recommendations offer the expert opinion to tailor treatment to the organ-specific severity using the ESSPRI definitions. If using glucocorticoids to treat systemic disease, they should be given at the minimum effective dose and for the shortest period of time needed to control active systemic disease, a recommendation based on retrospective or descriptive studies. Expert opinion called for using immunosuppressive treatments as glucocorticoid-sparing options for systemic disease, and this recommendation added that no particular immunosuppressive agent stands out as best compared with all available agents. In more than 95% of reported cases of systemic disease treatment in Sjögren’s patients, clinicians used the immunosuppressive drugs in association with glucocorticoids, Dr. Retamozo noted.

Finally, for systemic disease the recommendations cited evidence from controlled studies that B-cell targeted therapies, such as rituximab (Rituxan) and belimumab (Benlysta), may be considered in patients with severe, refractory systemic disease. An additional expert opinion was that the systemic, organ-specific approach should sequence treatments by using glucocorticoids first, followed by immunosuppressants, and finally biological drugs.

The recommendations finish with an entry that treatment of B-cell lymphoma be individualized based on the specific histopathologic subtype involved and the level of disease extension, an approach based on results from retrospective or descriptive studies.

The recommendations must still undergo final EULAR review and endorsement, with publication on track to occur before the end of 2018, Dr. Retamozo said.

She had no disclosures.

[email protected]

SOURCE: Retamozo S al. Ann Rheum Dis. 2018;77(Suppl 2):42. Abstract SP0159.

AMSTERDAM – The first recommendations from a rheumatology society for managing patients with Sjögren’s syndrome are nearing finalization by a EULAR task force, and they divide the treatment targets into sicca syndrome and systemic manifestations of the disease.

“In Sjögren’s, we always have two subtypes of patients: those who have sicca syndrome only, and those with sicca syndrome plus systemic disease,” explained Soledad Retamozo, MD, who presented the current version of the recommendations at the European Congress of Rheumatology. “We wanted to highlight that there are two types of patients,” said Dr. Retamozo, a rheumatologist at the University of Córdoba (Argentina). “It’s hard to treat patients with sicca syndrome plus fatigue and pain because there is no high-level evidence on how to do this; all we have is expert opinion,” Dr. Retamozo said in an interview.

Mitchel L. Zoler/MDedge News

In fact, roughly half of the recommendations have no supporting evidence base, as presented by Dr. Retamozo. That starts with all three general recommendations she presented:

• Patients with Sjögren’s should be managed at a center of expertise using a multidisciplinary approach, which she said should include ophthalmologists and dentists to help address the mouth and ocular manifestations of sicca syndrome.

• Patients with sicca syndrome should receive symptomatic relief with topical treatments.

• Systemic treatments – glucocorticoids, immunosuppressants, and biologicals – can be considered for patients with active systemic disease.

The statement’s specific recommendations start with managing oral dryness, an intervention that should begin by measuring salivary gland (SG) dysfunction. The document next recommends nonpharmacologic interventions for mild SG dysfunction, pharmacological stimulation for moderate SG dysfunction, and a saliva substitute for severe SG dysfunction. All three recommendations are evidence based, relying on results from either randomized trials or controlled studies.

The second target for topical treatments is ocular dryness, which starts with artificial tears, or ocular gels or ointments, recommendations based on randomized trials. Refractory or severe ocular dryness should receive eye drops that contain a nonsteroidal anti-inflammatory drug or a glucocorticoid, based on controlled study results, or autologous serum eye drops, a strategy tested in a randomized trial.

The recommendations then shift to dealing with systemic manifestations, starting with fatigue and pain, offering the expert recommendation to evaluate the contribution of comorbid diseases and assess their severity with tools such as the Eular Sjögren’s Syndrome Patient-Reported Index (ESSPRI) (Ann Rheum Dis. 2011 June;70[6]:968-72), the Profile of Fatigue, and the Brief Pain Inventory.

Using evidence from randomized trials, the recommendations tell clinicians to consider treatment with analgesics or pain-modifying agents for musculoskeletal pain by weighing the potential benefits and adverse effects from this treatment.

For other forms of systemic disease, the recommendations offer the expert opinion to tailor treatment to the organ-specific severity using the ESSPRI definitions. If using glucocorticoids to treat systemic disease, they should be given at the minimum effective dose and for the shortest period of time needed to control active systemic disease, a recommendation based on retrospective or descriptive studies. Expert opinion called for using immunosuppressive treatments as glucocorticoid-sparing options for systemic disease, and this recommendation added that no particular immunosuppressive agent stands out as best compared with all available agents. In more than 95% of reported cases of systemic disease treatment in Sjögren’s patients, clinicians used the immunosuppressive drugs in association with glucocorticoids, Dr. Retamozo noted.

Finally, for systemic disease the recommendations cited evidence from controlled studies that B-cell targeted therapies, such as rituximab (Rituxan) and belimumab (Benlysta), may be considered in patients with severe, refractory systemic disease. An additional expert opinion was that the systemic, organ-specific approach should sequence treatments by using glucocorticoids first, followed by immunosuppressants, and finally biological drugs.

The recommendations finish with an entry that treatment of B-cell lymphoma be individualized based on the specific histopathologic subtype involved and the level of disease extension, an approach based on results from retrospective or descriptive studies.

The recommendations must still undergo final EULAR review and endorsement, with publication on track to occur before the end of 2018, Dr. Retamozo said.

She had no disclosures.

[email protected]

SOURCE: Retamozo S al. Ann Rheum Dis. 2018;77(Suppl 2):42. Abstract SP0159.

AMSTERDAM – The first recommendations from a rheumatology society for managing patients with Sjögren’s syndrome are nearing finalization by a EULAR task force, and they divide the treatment targets into sicca syndrome and systemic manifestations of the disease.

“In Sjögren’s, we always have two subtypes of patients: those who have sicca syndrome only, and those with sicca syndrome plus systemic disease,” explained Soledad Retamozo, MD, who presented the current version of the recommendations at the European Congress of Rheumatology. “We wanted to highlight that there are two types of patients,” said Dr. Retamozo, a rheumatologist at the University of Córdoba (Argentina). “It’s hard to treat patients with sicca syndrome plus fatigue and pain because there is no high-level evidence on how to do this; all we have is expert opinion,” Dr. Retamozo said in an interview.

Mitchel L. Zoler/MDedge News

In fact, roughly half of the recommendations have no supporting evidence base, as presented by Dr. Retamozo. That starts with all three general recommendations she presented:

• Patients with Sjögren’s should be managed at a center of expertise using a multidisciplinary approach, which she said should include ophthalmologists and dentists to help address the mouth and ocular manifestations of sicca syndrome.

• Patients with sicca syndrome should receive symptomatic relief with topical treatments.

• Systemic treatments – glucocorticoids, immunosuppressants, and biologicals – can be considered for patients with active systemic disease.

The statement’s specific recommendations start with managing oral dryness, an intervention that should begin by measuring salivary gland (SG) dysfunction. The document next recommends nonpharmacologic interventions for mild SG dysfunction, pharmacological stimulation for moderate SG dysfunction, and a saliva substitute for severe SG dysfunction. All three recommendations are evidence based, relying on results from either randomized trials or controlled studies.

The second target for topical treatments is ocular dryness, which starts with artificial tears, or ocular gels or ointments, recommendations based on randomized trials. Refractory or severe ocular dryness should receive eye drops that contain a nonsteroidal anti-inflammatory drug or a glucocorticoid, based on controlled study results, or autologous serum eye drops, a strategy tested in a randomized trial.

The recommendations then shift to dealing with systemic manifestations, starting with fatigue and pain, offering the expert recommendation to evaluate the contribution of comorbid diseases and assess their severity with tools such as the Eular Sjögren’s Syndrome Patient-Reported Index (ESSPRI) (Ann Rheum Dis. 2011 June;70[6]:968-72), the Profile of Fatigue, and the Brief Pain Inventory.

Using evidence from randomized trials, the recommendations tell clinicians to consider treatment with analgesics or pain-modifying agents for musculoskeletal pain by weighing the potential benefits and adverse effects from this treatment.

For other forms of systemic disease, the recommendations offer the expert opinion to tailor treatment to the organ-specific severity using the ESSPRI definitions. If using glucocorticoids to treat systemic disease, they should be given at the minimum effective dose and for the shortest period of time needed to control active systemic disease, a recommendation based on retrospective or descriptive studies. Expert opinion called for using immunosuppressive treatments as glucocorticoid-sparing options for systemic disease, and this recommendation added that no particular immunosuppressive agent stands out as best compared with all available agents. In more than 95% of reported cases of systemic disease treatment in Sjögren’s patients, clinicians used the immunosuppressive drugs in association with glucocorticoids, Dr. Retamozo noted.

Finally, for systemic disease the recommendations cited evidence from controlled studies that B-cell targeted therapies, such as rituximab (Rituxan) and belimumab (Benlysta), may be considered in patients with severe, refractory systemic disease. An additional expert opinion was that the systemic, organ-specific approach should sequence treatments by using glucocorticoids first, followed by immunosuppressants, and finally biological drugs.

The recommendations finish with an entry that treatment of B-cell lymphoma be individualized based on the specific histopathologic subtype involved and the level of disease extension, an approach based on results from retrospective or descriptive studies.

The recommendations must still undergo final EULAR review and endorsement, with publication on track to occur before the end of 2018, Dr. Retamozo said.

She had no disclosures.

[email protected]

SOURCE: Retamozo S al. Ann Rheum Dis. 2018;77(Suppl 2):42. Abstract SP0159.

New clinical guidelines for pediatric hypertension resulted in increased prevalence of hypertension and improved sensitivity in detecting target organ damage among at-risk youth, according to findings published in Pediatrics.

In a clinical practice guideline (CPG) published in 2017, the American Academy of Pediatrics updated its 2004 guideline to include new reference tables for BP values in addition to new definitions of elevated BP and hypertension, including absolute BP cutoff values for adolescents aged 13 years and older (Pediatrics. 2017 Sep;140[6]:e20173035). This was intended to “emulate the recently updated adult hypertension guidelines and to simplify the process of identifying and classifying hypertension in adolescents,” wrote Michael Khoury, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, and his coauthors.

To evaluate the impact of the new guidelines on the prevalence of hypertension and associations with target organ damage, the investigators used data from a study on obesity and type 2 diabetes in 364 patients aged 10-17 years; 59% were obese, and 30% had type 2 diabetes. Three groups were identified: patients with obesity and type 2 diabetes, patients with obesity but no type 2 diabetes, and healthy (“lean”) controls.

Patients fasted overnight for a minimum of 10 hours, after which body mass index was calculated, blood pressure was taken, and anthropometric, laboratory, echocardiography, and carotid assessments were performed. Average BP measurements were categorized according to the 2004 guideline and to the new CPG.

In carotid ultrasonography assessments, a composite of carotid intima-media thickness was formed from the average of three sites, and a composite carotid intima-media thickness greater than or equal to the 90th percentile of that measured in the lean patients, who were the controls, was considered abnormal. In echocardiography assessments, left ventricular mass (LVM) and LVM index were calculated. Elevated LVM was defined by the pediatric cutoff of LVM index greater than or equal to 38.6 g/m.

For diastolic function, tissue Doppler velocities under the 10th percentile and an average early left ventricular filling/peak early myocardial velocity ratio greater than or equal to the 90th percentile in controls were considered abnormal. Lastly, pulse wave velocity (PWV) was measured to determine arterial stiffness, and a PWV greater than or equal to the 90th percentile for the controls was considered abnormal.

BP classification under the new guideline resulted in an increased prevalence of hypertension at 13% (10% stage 1, 3% stage 2), compared with the 2004 guideline at 8% (6% stage 1, 2% stage 2), with a P value of .007.

Of the 75 patients classified as having elevated BP in the 2004 guideline, 19 (25%) were reclassified as having stage 1 hypertension under the CPG. These 19 patients were older, compared with patients who remained in the elevated blood pressure category (16.5 ± 0.9 vs. 15.5 ± 1.7 years; P = .02). The patients who were reclassified also had higher body mass indexes (38.8 ± 8.2 vs. 33.6 ± 7.4; P = .01) and diastolic blood pressures (76.5 mm Hg ± 8.7 vs. 62.1 ± 12.2 mm Hg; P less than .001), Dr. Khoury and his colleagues reported.

Reclassification to a higher BP category was associated with increased odds of an abnormal target organ damage (TOD) values, and both guidelines produced similar odds, “suggesting that the two guidelines produce similar associations with TOD,” the authors wrote. Reclassification based on the CPG definition accounted for 31% of patients with increased LVM, compared with 20% as defined in the 2004 guideline (P less than .001), and for 33% of patients with abnormal PWV, compared with 23% in the 2004 guideline, suggesting improved sensitivity of hypertension categorization in detecting LVM. A similar effect was seen in other measures of TOD, the authors noted.

The findings suggest that, combined with the increased prevalence of hypertension under the new guidelines, “the CPG may contribute to an increased detection of abnormal LVM and other measures of TOD,” the authors wrote. “This, in turn, may contribute to risk stratification in clinical decision making for youth presenting with BP concerns,” they concluded.

The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures.

SOURCE: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.

New clinical guidelines for pediatric hypertension resulted in increased prevalence of hypertension and improved sensitivity in detecting target organ damage among at-risk youth, according to findings published in Pediatrics.

In a clinical practice guideline (CPG) published in 2017, the American Academy of Pediatrics updated its 2004 guideline to include new reference tables for BP values in addition to new definitions of elevated BP and hypertension, including absolute BP cutoff values for adolescents aged 13 years and older (Pediatrics. 2017 Sep;140[6]:e20173035). This was intended to “emulate the recently updated adult hypertension guidelines and to simplify the process of identifying and classifying hypertension in adolescents,” wrote Michael Khoury, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, and his coauthors.

To evaluate the impact of the new guidelines on the prevalence of hypertension and associations with target organ damage, the investigators used data from a study on obesity and type 2 diabetes in 364 patients aged 10-17 years; 59% were obese, and 30% had type 2 diabetes. Three groups were identified: patients with obesity and type 2 diabetes, patients with obesity but no type 2 diabetes, and healthy (“lean”) controls.

Patients fasted overnight for a minimum of 10 hours, after which body mass index was calculated, blood pressure was taken, and anthropometric, laboratory, echocardiography, and carotid assessments were performed. Average BP measurements were categorized according to the 2004 guideline and to the new CPG.

In carotid ultrasonography assessments, a composite of carotid intima-media thickness was formed from the average of three sites, and a composite carotid intima-media thickness greater than or equal to the 90th percentile of that measured in the lean patients, who were the controls, was considered abnormal. In echocardiography assessments, left ventricular mass (LVM) and LVM index were calculated. Elevated LVM was defined by the pediatric cutoff of LVM index greater than or equal to 38.6 g/m.

For diastolic function, tissue Doppler velocities under the 10th percentile and an average early left ventricular filling/peak early myocardial velocity ratio greater than or equal to the 90th percentile in controls were considered abnormal. Lastly, pulse wave velocity (PWV) was measured to determine arterial stiffness, and a PWV greater than or equal to the 90th percentile for the controls was considered abnormal.

BP classification under the new guideline resulted in an increased prevalence of hypertension at 13% (10% stage 1, 3% stage 2), compared with the 2004 guideline at 8% (6% stage 1, 2% stage 2), with a P value of .007.

Of the 75 patients classified as having elevated BP in the 2004 guideline, 19 (25%) were reclassified as having stage 1 hypertension under the CPG. These 19 patients were older, compared with patients who remained in the elevated blood pressure category (16.5 ± 0.9 vs. 15.5 ± 1.7 years; P = .02). The patients who were reclassified also had higher body mass indexes (38.8 ± 8.2 vs. 33.6 ± 7.4; P = .01) and diastolic blood pressures (76.5 mm Hg ± 8.7 vs. 62.1 ± 12.2 mm Hg; P less than .001), Dr. Khoury and his colleagues reported.

Reclassification to a higher BP category was associated with increased odds of an abnormal target organ damage (TOD) values, and both guidelines produced similar odds, “suggesting that the two guidelines produce similar associations with TOD,” the authors wrote. Reclassification based on the CPG definition accounted for 31% of patients with increased LVM, compared with 20% as defined in the 2004 guideline (P less than .001), and for 33% of patients with abnormal PWV, compared with 23% in the 2004 guideline, suggesting improved sensitivity of hypertension categorization in detecting LVM. A similar effect was seen in other measures of TOD, the authors noted.

The findings suggest that, combined with the increased prevalence of hypertension under the new guidelines, “the CPG may contribute to an increased detection of abnormal LVM and other measures of TOD,” the authors wrote. “This, in turn, may contribute to risk stratification in clinical decision making for youth presenting with BP concerns,” they concluded.

The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures.

SOURCE: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.

New clinical guidelines for pediatric hypertension resulted in increased prevalence of hypertension and improved sensitivity in detecting target organ damage among at-risk youth, according to findings published in Pediatrics.

In a clinical practice guideline (CPG) published in 2017, the American Academy of Pediatrics updated its 2004 guideline to include new reference tables for BP values in addition to new definitions of elevated BP and hypertension, including absolute BP cutoff values for adolescents aged 13 years and older (Pediatrics. 2017 Sep;140[6]:e20173035). This was intended to “emulate the recently updated adult hypertension guidelines and to simplify the process of identifying and classifying hypertension in adolescents,” wrote Michael Khoury, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, and his coauthors.

To evaluate the impact of the new guidelines on the prevalence of hypertension and associations with target organ damage, the investigators used data from a study on obesity and type 2 diabetes in 364 patients aged 10-17 years; 59% were obese, and 30% had type 2 diabetes. Three groups were identified: patients with obesity and type 2 diabetes, patients with obesity but no type 2 diabetes, and healthy (“lean”) controls.

Patients fasted overnight for a minimum of 10 hours, after which body mass index was calculated, blood pressure was taken, and anthropometric, laboratory, echocardiography, and carotid assessments were performed. Average BP measurements were categorized according to the 2004 guideline and to the new CPG.

In carotid ultrasonography assessments, a composite of carotid intima-media thickness was formed from the average of three sites, and a composite carotid intima-media thickness greater than or equal to the 90th percentile of that measured in the lean patients, who were the controls, was considered abnormal. In echocardiography assessments, left ventricular mass (LVM) and LVM index were calculated. Elevated LVM was defined by the pediatric cutoff of LVM index greater than or equal to 38.6 g/m.

For diastolic function, tissue Doppler velocities under the 10th percentile and an average early left ventricular filling/peak early myocardial velocity ratio greater than or equal to the 90th percentile in controls were considered abnormal. Lastly, pulse wave velocity (PWV) was measured to determine arterial stiffness, and a PWV greater than or equal to the 90th percentile for the controls was considered abnormal.

BP classification under the new guideline resulted in an increased prevalence of hypertension at 13% (10% stage 1, 3% stage 2), compared with the 2004 guideline at 8% (6% stage 1, 2% stage 2), with a P value of .007.

Of the 75 patients classified as having elevated BP in the 2004 guideline, 19 (25%) were reclassified as having stage 1 hypertension under the CPG. These 19 patients were older, compared with patients who remained in the elevated blood pressure category (16.5 ± 0.9 vs. 15.5 ± 1.7 years; P = .02). The patients who were reclassified also had higher body mass indexes (38.8 ± 8.2 vs. 33.6 ± 7.4; P = .01) and diastolic blood pressures (76.5 mm Hg ± 8.7 vs. 62.1 ± 12.2 mm Hg; P less than .001), Dr. Khoury and his colleagues reported.

Reclassification to a higher BP category was associated with increased odds of an abnormal target organ damage (TOD) values, and both guidelines produced similar odds, “suggesting that the two guidelines produce similar associations with TOD,” the authors wrote. Reclassification based on the CPG definition accounted for 31% of patients with increased LVM, compared with 20% as defined in the 2004 guideline (P less than .001), and for 33% of patients with abnormal PWV, compared with 23% in the 2004 guideline, suggesting improved sensitivity of hypertension categorization in detecting LVM. A similar effect was seen in other measures of TOD, the authors noted.

The findings suggest that, combined with the increased prevalence of hypertension under the new guidelines, “the CPG may contribute to an increased detection of abnormal LVM and other measures of TOD,” the authors wrote. “This, in turn, may contribute to risk stratification in clinical decision making for youth presenting with BP concerns,” they concluded.

The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures.

SOURCE: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.

A move toward more individualized treatment of hyperglycemia is coming in the next American Diabetes Association/European Association for the Study of Diabetes Consensus Report, according to John B. Buse, MD, PhD, cochair of the committee writing the new consensus statement.

He will present a draft of the statement on the management of hyperglycemia in type 2 diabetes at the ADA’s annual scientific sessions in Orlando.

When finalized – after revisions based on comments and feedback from diabetes care providers – clinical researchers, patient groups, payers, regulators, and stakeholders – the statement will update the last revision, issued in 2015.

“We are taking a new look at hyperglycemia based on the many studies conducted since 2014, particularly the cardiovascular outcomes trials,” Dr. Buse, the Verne S. Caviness Distinguished Professor in the division of endocrinology and metabolism and chief of endocrinology at the University of North Carolina, Chapel Hill, said in a statement.

A move toward more individualized treatment of hyperglycemia is coming in the next American Diabetes Association/European Association for the Study of Diabetes Consensus Report, according to John B. Buse, MD, PhD, cochair of the committee writing the new consensus statement.

He will present a draft of the statement on the management of hyperglycemia in type 2 diabetes at the ADA’s annual scientific sessions in Orlando.

When finalized – after revisions based on comments and feedback from diabetes care providers – clinical researchers, patient groups, payers, regulators, and stakeholders – the statement will update the last revision, issued in 2015.

“We are taking a new look at hyperglycemia based on the many studies conducted since 2014, particularly the cardiovascular outcomes trials,” Dr. Buse, the Verne S. Caviness Distinguished Professor in the division of endocrinology and metabolism and chief of endocrinology at the University of North Carolina, Chapel Hill, said in a statement.

A move toward more individualized treatment of hyperglycemia is coming in the next American Diabetes Association/European Association for the Study of Diabetes Consensus Report, according to John B. Buse, MD, PhD, cochair of the committee writing the new consensus statement.

He will present a draft of the statement on the management of hyperglycemia in type 2 diabetes at the ADA’s annual scientific sessions in Orlando.

When finalized – after revisions based on comments and feedback from diabetes care providers – clinical researchers, patient groups, payers, regulators, and stakeholders – the statement will update the last revision, issued in 2015.

“We are taking a new look at hyperglycemia based on the many studies conducted since 2014, particularly the cardiovascular outcomes trials,” Dr. Buse, the Verne S. Caviness Distinguished Professor in the division of endocrinology and metabolism and chief of endocrinology at the University of North Carolina, Chapel Hill, said in a statement.

Adding electrocardiography screening to standard cardiovascular disease assessment is not necessary for asymptomatic, low-risk adults, according to final recommendations from the U.S. Preventive Services Task Force.

In the statement published June 12 in JAMA, the USPSTF gave a D recommendation against using ECG screening to evaluate cardiovascular disease risk in asymptomatic, low-risk individuals and issued a statement that current evidence is inadequate (I statement) to evaluate the harms versus benefits of additional ECG for asymptomatic individuals who may be at medium to high risk for future cardiovascular events.

hepatus/iStockphoto

SOURCES: Jonas D et al. JAMA. 2018 Jun 12;319(22):2315-28; Curry S et al. JAMA. 2018 Jun 12;319(22):2308-14.

Adding electrocardiography screening to standard cardiovascular disease assessment is not necessary for asymptomatic, low-risk adults, according to final recommendations from the U.S. Preventive Services Task Force.

In the statement published June 12 in JAMA, the USPSTF gave a D recommendation against using ECG screening to evaluate cardiovascular disease risk in asymptomatic, low-risk individuals and issued a statement that current evidence is inadequate (I statement) to evaluate the harms versus benefits of additional ECG for asymptomatic individuals who may be at medium to high risk for future cardiovascular events.

hepatus/iStockphoto

SOURCES: Jonas D et al. JAMA. 2018 Jun 12;319(22):2315-28; Curry S et al. JAMA. 2018 Jun 12;319(22):2308-14.

Adding electrocardiography screening to standard cardiovascular disease assessment is not necessary for asymptomatic, low-risk adults, according to final recommendations from the U.S. Preventive Services Task Force.

In the statement published June 12 in JAMA, the USPSTF gave a D recommendation against using ECG screening to evaluate cardiovascular disease risk in asymptomatic, low-risk individuals and issued a statement that current evidence is inadequate (I statement) to evaluate the harms versus benefits of additional ECG for asymptomatic individuals who may be at medium to high risk for future cardiovascular events.

hepatus/iStockphoto

SOURCES: Jonas D et al. JAMA. 2018 Jun 12;319(22):2315-28; Curry S et al. JAMA. 2018 Jun 12;319(22):2308-14.