Physician associations are expressing mixed feelings about dramatic changes proposed for Year 3 of the Quality Payment Program (QPP) by the Centers for Medicare & Medicaid Services.

Copyright roobcio/Thinkstock

Under its 2019 QPP proposal, CMS plans to remove 34 process-based measures within the program considered to be low value or low priority so that providers can focus more on meaningful measures that affect health outcomes, according to the agency. CMS also calls for the streamlining of the “interoperability performance category” within the Merit-Based Incentive Payment System (MIPS) to create a more simplified scoring methodology.

In regard to alternative payment models (APMs), CMS seeks to update the Advanced APM Certified EHR Technology (CEHRT) threshold so that an Advanced APM must require at least 75% of eligible clinicians in each APM entity to use CEHRT. The agency also plans to extend the 8% revenue-based nominal amount standard for Advanced APMs through performance year 2024.

Ana Maria Lopez, MD, president for the American College of Physicians said the they were pleased that CMS proposed the removal of a number of quality measures deemed to be of low value. “ACP commends CMS for taking major steps to reduce unnecessary administrative tasks that are detracting from the patient-physician relationship,” Dr. Lopez said in a statement.

But ACP officials also noted that they were disappointed that CMS did not heed calls to streamline MIPS requirements and scoring, establish a minimum 90-day reporting period for all performance categories, or reduce the total number of quality measures.

ACP supports CMS’ promoting of interoperability by requiring CEHRT, but it urged the agency to allow at least 6 months for vendors and physicians to implement system upgrades in order to ensure a smooth transition and avoid disruptions to patient care. Additionally, CMS needs to “think about ways to mitigate costs associated with implementation, especially for small practices,” Dr. Lopez said in the statement.

In an interview, Michael L. Munger, MD, president for the American Academy of Family Physicians, said that his group is reviewing the proposed QPP regulations and plans to offer its full perspective during the comment period.

“Our initial assessment indicates CMS continues progress to simplify and modernize in documentation requirements for evaluation and management office visits,” Dr. Munger said. “Reforming the U.S. health care system is an ongoing process, and the AAFP looks forward to working with CMS to ensure continued progress.”

As part of the proposed QPP changes, CMS for the first time is proposing to allow physicians to opt-in to the MIPS program if they are prepared to meet the program’s requirements. The proposal also adds a new exemption to MIPS participation: Doctors who perform 200 or fewer services under the Medicare fee schedule. The proposal retains its previous exemption thresholds for participating in MIPS – physicians who bill Medicare $90,000 or less annually and see 200 or fewer Medicare patients are excused from the program.

CMS also proposes to add new episode-based measures to the cost performance category and to create an option to use facility-based quality and cost performance measures for certain facility-based clinicians. The QPP proposal includes a number of changes for small medical practices, which include the following:

• Continuing the small practice bonus, but including it in the quality performance category score of clinicians in small practices instead of as a standalone bonus.
• Awarding small practices three points for quality measures that don’t meet the data completeness requirements.
• Consolidating the low-volume threshold determination periods with the determination period for identifying a small practice.

David Daikh, MD, president for the American College of Rheumatology, said the ACR appreciates CMS’ emphasis on supporting the development of alternative payment models (APMs) and is encouraged by the agency’s proposal to allow more physicians to participate.

“However, we are concerned that eliminating the MIPS small practice bonus as a stand-alone bonus and instead folding it into the quality performance score would dilute the bonus and hurt small and rural providers,” Dr. Daikh said in a statement. “The ACR strongly supports maintaining the small practice bonus as a five-point stand-alone bonus that is added to the final score.”

Meanwhile, Jerry Penso, MD, president and CEO for the American Medical Group Association expressed disappointment that CMS did not lower its exclusion threshold for MIPS. Through the Bipartisan Budget Act of 2018, CMS plans to continue “the gradual implementation of certain MIPS requirements to ease administrative burden on clinicians,” according to a CMS fact sheet. This includes flexible performance thresholds until the fifth year of the QPP. The agency previously required the MIPS cost performance category to have a weight of 30% in Year 3 of the program (performance period 2019); however, the weight is now required to be no less than 10% and no more than 30% for the third, fourth and fifth years of the QPP.

Dr. Penso noted that as authorized by the Medicare Access and CHIP Reauthorization Act (MACRA), providers were given the opportunity to earn an adjustment of up to 7% on their Medicare Part B payments in 2021 based on their 2019 performance.

“However, as indicated in [the] proposal, CMS estimates the overall payment adjustment will be 2%,” Dr. Penso said in a statement. “We are concerned that CMS has again opted not to recognize the efforts of high-performing AMGA members. As we enter the program’s third year, it is time for CMS to honor congressional intent and use MIPS to create value for Medicare.”

Some specialty associations, including the American Academy of Dermatology, said they are still reviewing the proposed policies and could not comment on the changes at this time.

“The American Academy of Dermatology is still looking at the proposed rule and the implications it may have on board-certified dermatologists and their patients,” an association spokesperson said in an interview.

Comments on the proposed rule will be accepted at www.regulations.gov until Sept. 10.

Physician associations are expressing mixed feelings about dramatic changes proposed for Year 3 of the Quality Payment Program (QPP) by the Centers for Medicare & Medicaid Services.

Copyright roobcio/Thinkstock

Under its 2019 QPP proposal, CMS plans to remove 34 process-based measures within the program considered to be low value or low priority so that providers can focus more on meaningful measures that affect health outcomes, according to the agency. CMS also calls for the streamlining of the “interoperability performance category” within the Merit-Based Incentive Payment System (MIPS) to create a more simplified scoring methodology.

In regard to alternative payment models (APMs), CMS seeks to update the Advanced APM Certified EHR Technology (CEHRT) threshold so that an Advanced APM must require at least 75% of eligible clinicians in each APM entity to use CEHRT. The agency also plans to extend the 8% revenue-based nominal amount standard for Advanced APMs through performance year 2024.

Ana Maria Lopez, MD, president for the American College of Physicians said the they were pleased that CMS proposed the removal of a number of quality measures deemed to be of low value. “ACP commends CMS for taking major steps to reduce unnecessary administrative tasks that are detracting from the patient-physician relationship,” Dr. Lopez said in a statement.

But ACP officials also noted that they were disappointed that CMS did not heed calls to streamline MIPS requirements and scoring, establish a minimum 90-day reporting period for all performance categories, or reduce the total number of quality measures.

ACP supports CMS’ promoting of interoperability by requiring CEHRT, but it urged the agency to allow at least 6 months for vendors and physicians to implement system upgrades in order to ensure a smooth transition and avoid disruptions to patient care. Additionally, CMS needs to “think about ways to mitigate costs associated with implementation, especially for small practices,” Dr. Lopez said in the statement.

In an interview, Michael L. Munger, MD, president for the American Academy of Family Physicians, said that his group is reviewing the proposed QPP regulations and plans to offer its full perspective during the comment period.

“Our initial assessment indicates CMS continues progress to simplify and modernize in documentation requirements for evaluation and management office visits,” Dr. Munger said. “Reforming the U.S. health care system is an ongoing process, and the AAFP looks forward to working with CMS to ensure continued progress.”

As part of the proposed QPP changes, CMS for the first time is proposing to allow physicians to opt-in to the MIPS program if they are prepared to meet the program’s requirements. The proposal also adds a new exemption to MIPS participation: Doctors who perform 200 or fewer services under the Medicare fee schedule. The proposal retains its previous exemption thresholds for participating in MIPS – physicians who bill Medicare $90,000 or less annually and see 200 or fewer Medicare patients are excused from the program.

CMS also proposes to add new episode-based measures to the cost performance category and to create an option to use facility-based quality and cost performance measures for certain facility-based clinicians. The QPP proposal includes a number of changes for small medical practices, which include the following:

• Continuing the small practice bonus, but including it in the quality performance category score of clinicians in small practices instead of as a standalone bonus.
• Awarding small practices three points for quality measures that don’t meet the data completeness requirements.
• Consolidating the low-volume threshold determination periods with the determination period for identifying a small practice.

David Daikh, MD, president for the American College of Rheumatology, said the ACR appreciates CMS’ emphasis on supporting the development of alternative payment models (APMs) and is encouraged by the agency’s proposal to allow more physicians to participate.

“However, we are concerned that eliminating the MIPS small practice bonus as a stand-alone bonus and instead folding it into the quality performance score would dilute the bonus and hurt small and rural providers,” Dr. Daikh said in a statement. “The ACR strongly supports maintaining the small practice bonus as a five-point stand-alone bonus that is added to the final score.”

Meanwhile, Jerry Penso, MD, president and CEO for the American Medical Group Association expressed disappointment that CMS did not lower its exclusion threshold for MIPS. Through the Bipartisan Budget Act of 2018, CMS plans to continue “the gradual implementation of certain MIPS requirements to ease administrative burden on clinicians,” according to a CMS fact sheet. This includes flexible performance thresholds until the fifth year of the QPP. The agency previously required the MIPS cost performance category to have a weight of 30% in Year 3 of the program (performance period 2019); however, the weight is now required to be no less than 10% and no more than 30% for the third, fourth and fifth years of the QPP.

Dr. Penso noted that as authorized by the Medicare Access and CHIP Reauthorization Act (MACRA), providers were given the opportunity to earn an adjustment of up to 7% on their Medicare Part B payments in 2021 based on their 2019 performance.

“However, as indicated in [the] proposal, CMS estimates the overall payment adjustment will be 2%,” Dr. Penso said in a statement. “We are concerned that CMS has again opted not to recognize the efforts of high-performing AMGA members. As we enter the program’s third year, it is time for CMS to honor congressional intent and use MIPS to create value for Medicare.”

Some specialty associations, including the American Academy of Dermatology, said they are still reviewing the proposed policies and could not comment on the changes at this time.

“The American Academy of Dermatology is still looking at the proposed rule and the implications it may have on board-certified dermatologists and their patients,” an association spokesperson said in an interview.

Comments on the proposed rule will be accepted at www.regulations.gov until Sept. 10.

Physician associations are expressing mixed feelings about dramatic changes proposed for Year 3 of the Quality Payment Program (QPP) by the Centers for Medicare & Medicaid Services.

Copyright roobcio/Thinkstock

Under its 2019 QPP proposal, CMS plans to remove 34 process-based measures within the program considered to be low value or low priority so that providers can focus more on meaningful measures that affect health outcomes, according to the agency. CMS also calls for the streamlining of the “interoperability performance category” within the Merit-Based Incentive Payment System (MIPS) to create a more simplified scoring methodology.

In regard to alternative payment models (APMs), CMS seeks to update the Advanced APM Certified EHR Technology (CEHRT) threshold so that an Advanced APM must require at least 75% of eligible clinicians in each APM entity to use CEHRT. The agency also plans to extend the 8% revenue-based nominal amount standard for Advanced APMs through performance year 2024.

Ana Maria Lopez, MD, president for the American College of Physicians said the they were pleased that CMS proposed the removal of a number of quality measures deemed to be of low value. “ACP commends CMS for taking major steps to reduce unnecessary administrative tasks that are detracting from the patient-physician relationship,” Dr. Lopez said in a statement.

But ACP officials also noted that they were disappointed that CMS did not heed calls to streamline MIPS requirements and scoring, establish a minimum 90-day reporting period for all performance categories, or reduce the total number of quality measures.

ACP supports CMS’ promoting of interoperability by requiring CEHRT, but it urged the agency to allow at least 6 months for vendors and physicians to implement system upgrades in order to ensure a smooth transition and avoid disruptions to patient care. Additionally, CMS needs to “think about ways to mitigate costs associated with implementation, especially for small practices,” Dr. Lopez said in the statement.

In an interview, Michael L. Munger, MD, president for the American Academy of Family Physicians, said that his group is reviewing the proposed QPP regulations and plans to offer its full perspective during the comment period.

“Our initial assessment indicates CMS continues progress to simplify and modernize in documentation requirements for evaluation and management office visits,” Dr. Munger said. “Reforming the U.S. health care system is an ongoing process, and the AAFP looks forward to working with CMS to ensure continued progress.”

As part of the proposed QPP changes, CMS for the first time is proposing to allow physicians to opt-in to the MIPS program if they are prepared to meet the program’s requirements. The proposal also adds a new exemption to MIPS participation: Doctors who perform 200 or fewer services under the Medicare fee schedule. The proposal retains its previous exemption thresholds for participating in MIPS – physicians who bill Medicare $90,000 or less annually and see 200 or fewer Medicare patients are excused from the program.

CMS also proposes to add new episode-based measures to the cost performance category and to create an option to use facility-based quality and cost performance measures for certain facility-based clinicians. The QPP proposal includes a number of changes for small medical practices, which include the following:

• Continuing the small practice bonus, but including it in the quality performance category score of clinicians in small practices instead of as a standalone bonus.
• Awarding small practices three points for quality measures that don’t meet the data completeness requirements.
• Consolidating the low-volume threshold determination periods with the determination period for identifying a small practice.

David Daikh, MD, president for the American College of Rheumatology, said the ACR appreciates CMS’ emphasis on supporting the development of alternative payment models (APMs) and is encouraged by the agency’s proposal to allow more physicians to participate.

“However, we are concerned that eliminating the MIPS small practice bonus as a stand-alone bonus and instead folding it into the quality performance score would dilute the bonus and hurt small and rural providers,” Dr. Daikh said in a statement. “The ACR strongly supports maintaining the small practice bonus as a five-point stand-alone bonus that is added to the final score.”

Meanwhile, Jerry Penso, MD, president and CEO for the American Medical Group Association expressed disappointment that CMS did not lower its exclusion threshold for MIPS. Through the Bipartisan Budget Act of 2018, CMS plans to continue “the gradual implementation of certain MIPS requirements to ease administrative burden on clinicians,” according to a CMS fact sheet. This includes flexible performance thresholds until the fifth year of the QPP. The agency previously required the MIPS cost performance category to have a weight of 30% in Year 3 of the program (performance period 2019); however, the weight is now required to be no less than 10% and no more than 30% for the third, fourth and fifth years of the QPP.

Dr. Penso noted that as authorized by the Medicare Access and CHIP Reauthorization Act (MACRA), providers were given the opportunity to earn an adjustment of up to 7% on their Medicare Part B payments in 2021 based on their 2019 performance.

“However, as indicated in [the] proposal, CMS estimates the overall payment adjustment will be 2%,” Dr. Penso said in a statement. “We are concerned that CMS has again opted not to recognize the efforts of high-performing AMGA members. As we enter the program’s third year, it is time for CMS to honor congressional intent and use MIPS to create value for Medicare.”

Some specialty associations, including the American Academy of Dermatology, said they are still reviewing the proposed policies and could not comment on the changes at this time.

“The American Academy of Dermatology is still looking at the proposed rule and the implications it may have on board-certified dermatologists and their patients,” an association spokesperson said in an interview.

Comments on the proposed rule will be accepted at www.regulations.gov until Sept. 10.

Surgeons in the United States have been slow to adopt minimally invasive surgical techniques for inguinal hernia repairs, according to data from more than 6,000 patients.

“The benefit of MIS over open repair is recognized for patients with bilateral or recurrent inguinal hernias, and current guidelines recommend MIS repair for these cases,” wrote Joceline V. Vu, MD, of the University of Michigan, Ann Arbor, and her colleagues.

In a study published in Surgical Endoscopy, the researchers assessed surgeons’ practice patterns for hernia repair, with a primary outcome of minimally invasive surgery (MIS) rates per individual surgeon. They reviewed data from a statewide clinical registry of 6,723 adults older than 18 years who underwent elective hernia surgery in Michigan between 2012 and 2016.

Overall, the surgeons’ use of MIS varied, but more than half (58%) of the surgeons performed no MIS for hernia repair. For those who did use MIS, it was used in 41% of bilateral hernias and 38% of recurrent hernias.

Surgeons were significantly less likely to use MIS for hernia on patients aged 65 years and older (odds ratio, 0.68, P = .003), or those who were black (OR 0.75, P = .045). MIS repair also was significantly less likely for patients with chronic obstructive pulmonary disease (OR 0.57, P less than .001) or patients in American Society of Anesthesiologists Classification under 3 (OR 0.79, P less than .001).

Of the 227 surgeons who performed MIS, 71 (31%) had MIS utilization rates of 75% or higher and were defined as high-utilization surgeons. Overall, 75% of the MIS repairs were performed by 14% of the surgeons.

The surgeons with the highest use of MIS were unevenly distributed across the state; the Ann Arbor region had the highest percentage of high MIS-use surgeons (22%), compared with the Lansing area, in which 2% of surgeons were high users of MIS.

The risk-adjusted rate of MIS for inguinal hernia repair varied significantly across six regions of the state, from 10% to 48%, and the regions with the highest rates were those with the highest percentage of high-MIS use surgeons.

“These findings suggest that a large portion of decision making to offer MIS repair may depend on surgeon differences, rather than clinical appropriateness,” the researchers said. “The likelihood that a patient receives MIS repair may thus be predetermined by the surgeon to whom they are referred,” they added.

“Whether through novel training interventions or by establishing regional referral networks to improve access to MIS repair, improvement in MIS delivery and access is needed to reduce disparity and promote evidence-based practice,” they concluded.

The findings were limited by several factors including the potential for bias because of the observational nature of the study, the potential lack of generalizability of the findings, and lack of data on the particular attributes of the hernias, the researchers said.

Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.

SOURCE: Vu JV et al. Surg Endosc. 2018 Jul 9. doi: 10.1007/s00464-018-6322-x.

Surgeons in the United States have been slow to adopt minimally invasive surgical techniques for inguinal hernia repairs, according to data from more than 6,000 patients.

“The benefit of MIS over open repair is recognized for patients with bilateral or recurrent inguinal hernias, and current guidelines recommend MIS repair for these cases,” wrote Joceline V. Vu, MD, of the University of Michigan, Ann Arbor, and her colleagues.

In a study published in Surgical Endoscopy, the researchers assessed surgeons’ practice patterns for hernia repair, with a primary outcome of minimally invasive surgery (MIS) rates per individual surgeon. They reviewed data from a statewide clinical registry of 6,723 adults older than 18 years who underwent elective hernia surgery in Michigan between 2012 and 2016.

Overall, the surgeons’ use of MIS varied, but more than half (58%) of the surgeons performed no MIS for hernia repair. For those who did use MIS, it was used in 41% of bilateral hernias and 38% of recurrent hernias.

Surgeons were significantly less likely to use MIS for hernia on patients aged 65 years and older (odds ratio, 0.68, P = .003), or those who were black (OR 0.75, P = .045). MIS repair also was significantly less likely for patients with chronic obstructive pulmonary disease (OR 0.57, P less than .001) or patients in American Society of Anesthesiologists Classification under 3 (OR 0.79, P less than .001).

Of the 227 surgeons who performed MIS, 71 (31%) had MIS utilization rates of 75% or higher and were defined as high-utilization surgeons. Overall, 75% of the MIS repairs were performed by 14% of the surgeons.

The surgeons with the highest use of MIS were unevenly distributed across the state; the Ann Arbor region had the highest percentage of high MIS-use surgeons (22%), compared with the Lansing area, in which 2% of surgeons were high users of MIS.

The risk-adjusted rate of MIS for inguinal hernia repair varied significantly across six regions of the state, from 10% to 48%, and the regions with the highest rates were those with the highest percentage of high-MIS use surgeons.

“These findings suggest that a large portion of decision making to offer MIS repair may depend on surgeon differences, rather than clinical appropriateness,” the researchers said. “The likelihood that a patient receives MIS repair may thus be predetermined by the surgeon to whom they are referred,” they added.

“Whether through novel training interventions or by establishing regional referral networks to improve access to MIS repair, improvement in MIS delivery and access is needed to reduce disparity and promote evidence-based practice,” they concluded.

The findings were limited by several factors including the potential for bias because of the observational nature of the study, the potential lack of generalizability of the findings, and lack of data on the particular attributes of the hernias, the researchers said.

Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.

SOURCE: Vu JV et al. Surg Endosc. 2018 Jul 9. doi: 10.1007/s00464-018-6322-x.

Surgeons in the United States have been slow to adopt minimally invasive surgical techniques for inguinal hernia repairs, according to data from more than 6,000 patients.

“The benefit of MIS over open repair is recognized for patients with bilateral or recurrent inguinal hernias, and current guidelines recommend MIS repair for these cases,” wrote Joceline V. Vu, MD, of the University of Michigan, Ann Arbor, and her colleagues.

In a study published in Surgical Endoscopy, the researchers assessed surgeons’ practice patterns for hernia repair, with a primary outcome of minimally invasive surgery (MIS) rates per individual surgeon. They reviewed data from a statewide clinical registry of 6,723 adults older than 18 years who underwent elective hernia surgery in Michigan between 2012 and 2016.

Overall, the surgeons’ use of MIS varied, but more than half (58%) of the surgeons performed no MIS for hernia repair. For those who did use MIS, it was used in 41% of bilateral hernias and 38% of recurrent hernias.

Surgeons were significantly less likely to use MIS for hernia on patients aged 65 years and older (odds ratio, 0.68, P = .003), or those who were black (OR 0.75, P = .045). MIS repair also was significantly less likely for patients with chronic obstructive pulmonary disease (OR 0.57, P less than .001) or patients in American Society of Anesthesiologists Classification under 3 (OR 0.79, P less than .001).

Of the 227 surgeons who performed MIS, 71 (31%) had MIS utilization rates of 75% or higher and were defined as high-utilization surgeons. Overall, 75% of the MIS repairs were performed by 14% of the surgeons.

The surgeons with the highest use of MIS were unevenly distributed across the state; the Ann Arbor region had the highest percentage of high MIS-use surgeons (22%), compared with the Lansing area, in which 2% of surgeons were high users of MIS.

The risk-adjusted rate of MIS for inguinal hernia repair varied significantly across six regions of the state, from 10% to 48%, and the regions with the highest rates were those with the highest percentage of high-MIS use surgeons.

“These findings suggest that a large portion of decision making to offer MIS repair may depend on surgeon differences, rather than clinical appropriateness,” the researchers said. “The likelihood that a patient receives MIS repair may thus be predetermined by the surgeon to whom they are referred,” they added.

“Whether through novel training interventions or by establishing regional referral networks to improve access to MIS repair, improvement in MIS delivery and access is needed to reduce disparity and promote evidence-based practice,” they concluded.

The findings were limited by several factors including the potential for bias because of the observational nature of the study, the potential lack of generalizability of the findings, and lack of data on the particular attributes of the hernias, the researchers said.

Dr. Vu disclosed funding from the National Institutes of Health but had no financial conflicts to disclose. One of the study coauthors disclosed a relationship with Medtronic.

SOURCE: Vu JV et al. Surg Endosc. 2018 Jul 9. doi: 10.1007/s00464-018-6322-x.

Cervical dysplasia is commonly diagnosed in women who have completed childbearing and don’t desire future fertility. While diagnostic and/or definitive therapy for cervical dysplasia can include hysterectomy, there are important considerations to make when offering this procedure to patients.

Pitfalls

Hysterectomy is commonly requested by patients upon learning of cervical dysplasia, particularly if they have chronic human papillomavirus (HPV) infection and have experienced years of frequent surveillance and interventions. They may see hysterectomy as an option to avoid this close surveillance and to be free of their dysplasia. There are two main concerns with offering hysterectomy as the primary surgical option for the management of dysplasia. Firstly, it may not be curative, and secondly, it may be an inadequate excisional procedure, particularly if the patient has occult invasive disease that has not been adequately diagnosed with a loop electrosurgical excision procedure (LEEP) or a cone biopsy procedure.

It is important to counsel these patients that surgery is not a treatment for high-risk HPV infection, which is the underlying etiology of their disease. With that etiology, HPV infection is likely to persist after hysterectomy and they may develop vaginal or vulvar dysplasia. Therefore, the American Society for Colposcopy and Cervical Pathology recommends that cytology and/or high-risk HPV surveillance continue following hysterectomy if that surgery was performed for dysplasia.¹ Hysterectomy is not a means to avoid years of surveillance testing. Approximately 10% of women who have hysterectomy for cervical dysplasia develop vaginal dysplasia or cancer after surgery.^2,3 This is similar to the likelihood of recurrent dysplasia after an alternative excisional procedure. In my experience, this diagnosis is often met with enormous frustration for the patient who thought that her hysterectomy would be the cure of her HPV-related disease. Thorough colposcopic evaluation of the vagina can be technically challenging after hysterectomy because of difficulty adequately visualizing lesions within the vaginal rugations, particularly within the puckered lateral vaginal fornices, the most common location for dysplasia.³ We will explore the diagnosis and treatment options for vaginal dysplasia further in a future column.

It is critical that, if patients are offered hysterectomy for treatment of cervical dysplasia, they are counseled that it may not be curative, that they will require long-term vaginal surveillance, and that they are at continued risk for vaginal and vulvar cancer.

An additional concern with performing hysterectomy for definitive management of cervical dysplasia is the concern that occult cancer may be missed preoperatively, and that the hysterectomy is inadequate surgical clearance of the disease. Approximately 2%-5% of patients with a high-grade squamous intraepithelial lesion or equivocal Pap test have occult cervical cancer.⁴ A similar proportion of patients with cervical intraepithelial neoplasia stage III or adenocarcinoma in situ on colposcopy biopsy have invasive carcinoma on evaluation of an excisional specimen.⁵ The traditional surgical approach has dictated that a modified (type II) or extended (type III) radical hysterectomy be performed in the setting of FIGO stage IA2 or greater cervical cancer. Radical hysterectomies remove parametrial tissue, effectively achieving a wider margin around the primary lesion. This is important because cervical cancer primarily spreads via direct extension.

The appropriate radicality of surgery for microscopic lesions is debated. It has been proposed that for very small, low-risk lesions, a traditional extrafascial hysterectomy or trachelectomy, or possibly even a large conization, may be adequate.⁶ However, this is controversial, and National Comprehensive Cancer Network guidelines still advocate for radical procedures for these lesions.⁷ Certainly an excisional procedure (LEEP or cone) should first be performed to define the size and histologic features of the lesion, and ideally, evaluation and counseling with a gynecologic oncologist should be performed prior to offering patients with a stage IA2 or greater lesion an extrafascial hysterectomy. Additionally, a separate decision would need to be made regarding the need for lymphadenectomy, as this is typically recommended for patients with stage IA2 or greater lesions.

Patients should be counseled that, if extrafascial (simple) hysterectomy is chosen as the primary excisional procedure, they may require additional therapy (additional surgery, or radiation and possibly chemotherapy) if cancer is found in the specimen and the parametrial margin is inadequate. Additionally, and of more concern, if the lesion is a bulky lesion extending into the parametrium and not recognized preoperatively, a “cut-through” hysterectomy will be inadvertently performed (in which margins are grossly positive). These situations typically feature heavy blood loss with patients at increased risk for immediate surgical complications. Postoperatively, prognosis is substantially worse for patients who have had a cut-through hysterectomy, compared stage for stage with patients who primarily received a radical procedure with negative margins or primary chemotherapy and radiation.⁸ Otherwise said, their risk for death is higher if this error is made. Therefore a thorough examination is essential prior to performing hysterectomy for dysplasia. Any suspicion of bulky cancer should be considered a contraindication for proceeding.
 

Preoperative evaluation

As a rule, no patient should transition directly from cytologic evaluation with Pap screening to hysterectomy. A colposcopic evaluation of the cervix and vagina accompanied with a thorough bimanual rectovaginal examination should always be performed first. Biopsies of the ectocervix and ideally the endocervix should be obtained because the accuracy of histology is greater than that of cytology. For patients with cervical intraepithelial neoplasia stage I lesions, hysterectomy is not appropriate, as these patients have an extremely low risk for the development of cervical cancer, and the risks and costs of hysterectomy are not justified in such a population.

Surgeons should wait at least 6 weeks following conization or LEEP before performing hysterectomy in order to minimize the likelihood of perioperative complications.⁹

Substituting LEEP or cone with hysterectomy

In general, it is the most prudent approach to first perform a diagnostic excision with LEEP or cone biopsy before proceeding with hysterectomy for definitive surgery. However, there may be some situations in which this is not feasible. In patients whose cervix is very small and flush with the vagina, an excisional procedure may not be technically possible without concern for damage to adjacent structures. In these patients, after a thorough exam has evaluated for gross disease, a hysterectomy may be the only way to adequately diagnose and treat high-grade dysplasia through excision. For patients with limited access to resources, transportation, or a concern for noncompliance with follow-up, surgeons may wish to offer patients primary hysterectomy rather than a staged procedure.

Hysterectomy remains a potential option for treatment of cervical dysplasia. However, patients should be made aware of the risks of undertreatment of occult cancers, the need for long-term surveillance testing, and the risk for future vaginal dysplasia or cancer. Ideally a comprehensive, stepwise assessment from cytology to colposcopy and examination to diagnostic excisional procedure will first take place to proceed safely with this approach.

References

1. Saslow D et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72.

2. Schockaert S et al. Incidence of vaginal intraepithelial neoplasia after hysterectomy for cervical intraepithelial neoplasia: a retrospective study. Am J Obstet Gynecol. 2008 Aug;199(2):113.e1-5.

3. Kalogirou D et al. Vaginal intraepithelial neoplasia (VAIN) following hysterectomy in patients treated for carcinoma in situ of the cervix. Eur J Gynaecol Oncol. 1997;18(3):188-91.

4. Landy R et al. Evaluating cytology for the detection of invasive cervical cancer. Cytopathology. 2016 Jun;27(3):201-9.

5. Latif NA et al. Management of adenocarcinoma in situ of the uterine cervix: a comparison of loop electrosurgical excision procedure and cold knife conization. J Low Genit Tract Dis. 2015 Apr;19(2):97-102.

6. Bai H et al. The potential for less radical surgery in women with stage IA2-IB1 cervical cancer. Int J Gynaecol Obstet. 2015 Sep;130(3):235-40.

7. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Version 2.2018. 2018 Jun 26.

8. Barber HR et al. Operative management of patients previously operated upon for a benign lesion with cervical cancer as a surprise finding. Am J Obstet Gynecol. 1968 Aug 1;101(7):959-65.

9. Sullivan SA et al. Association between timing of cervical excision procedure to minimally invasive hysterectomy and surgical complications. Gynecol Oncol. 2017 Feb;144(2):294-298.

Cervical dysplasia is commonly diagnosed in women who have completed childbearing and don’t desire future fertility. While diagnostic and/or definitive therapy for cervical dysplasia can include hysterectomy, there are important considerations to make when offering this procedure to patients.

Pitfalls

Hysterectomy is commonly requested by patients upon learning of cervical dysplasia, particularly if they have chronic human papillomavirus (HPV) infection and have experienced years of frequent surveillance and interventions. They may see hysterectomy as an option to avoid this close surveillance and to be free of their dysplasia. There are two main concerns with offering hysterectomy as the primary surgical option for the management of dysplasia. Firstly, it may not be curative, and secondly, it may be an inadequate excisional procedure, particularly if the patient has occult invasive disease that has not been adequately diagnosed with a loop electrosurgical excision procedure (LEEP) or a cone biopsy procedure.

It is important to counsel these patients that surgery is not a treatment for high-risk HPV infection, which is the underlying etiology of their disease. With that etiology, HPV infection is likely to persist after hysterectomy and they may develop vaginal or vulvar dysplasia. Therefore, the American Society for Colposcopy and Cervical Pathology recommends that cytology and/or high-risk HPV surveillance continue following hysterectomy if that surgery was performed for dysplasia.¹ Hysterectomy is not a means to avoid years of surveillance testing. Approximately 10% of women who have hysterectomy for cervical dysplasia develop vaginal dysplasia or cancer after surgery.^2,3 This is similar to the likelihood of recurrent dysplasia after an alternative excisional procedure. In my experience, this diagnosis is often met with enormous frustration for the patient who thought that her hysterectomy would be the cure of her HPV-related disease. Thorough colposcopic evaluation of the vagina can be technically challenging after hysterectomy because of difficulty adequately visualizing lesions within the vaginal rugations, particularly within the puckered lateral vaginal fornices, the most common location for dysplasia.³ We will explore the diagnosis and treatment options for vaginal dysplasia further in a future column.

It is critical that, if patients are offered hysterectomy for treatment of cervical dysplasia, they are counseled that it may not be curative, that they will require long-term vaginal surveillance, and that they are at continued risk for vaginal and vulvar cancer.

An additional concern with performing hysterectomy for definitive management of cervical dysplasia is the concern that occult cancer may be missed preoperatively, and that the hysterectomy is inadequate surgical clearance of the disease. Approximately 2%-5% of patients with a high-grade squamous intraepithelial lesion or equivocal Pap test have occult cervical cancer.⁴ A similar proportion of patients with cervical intraepithelial neoplasia stage III or adenocarcinoma in situ on colposcopy biopsy have invasive carcinoma on evaluation of an excisional specimen.⁵ The traditional surgical approach has dictated that a modified (type II) or extended (type III) radical hysterectomy be performed in the setting of FIGO stage IA2 or greater cervical cancer. Radical hysterectomies remove parametrial tissue, effectively achieving a wider margin around the primary lesion. This is important because cervical cancer primarily spreads via direct extension.

The appropriate radicality of surgery for microscopic lesions is debated. It has been proposed that for very small, low-risk lesions, a traditional extrafascial hysterectomy or trachelectomy, or possibly even a large conization, may be adequate.⁶ However, this is controversial, and National Comprehensive Cancer Network guidelines still advocate for radical procedures for these lesions.⁷ Certainly an excisional procedure (LEEP or cone) should first be performed to define the size and histologic features of the lesion, and ideally, evaluation and counseling with a gynecologic oncologist should be performed prior to offering patients with a stage IA2 or greater lesion an extrafascial hysterectomy. Additionally, a separate decision would need to be made regarding the need for lymphadenectomy, as this is typically recommended for patients with stage IA2 or greater lesions.

Patients should be counseled that, if extrafascial (simple) hysterectomy is chosen as the primary excisional procedure, they may require additional therapy (additional surgery, or radiation and possibly chemotherapy) if cancer is found in the specimen and the parametrial margin is inadequate. Additionally, and of more concern, if the lesion is a bulky lesion extending into the parametrium and not recognized preoperatively, a “cut-through” hysterectomy will be inadvertently performed (in which margins are grossly positive). These situations typically feature heavy blood loss with patients at increased risk for immediate surgical complications. Postoperatively, prognosis is substantially worse for patients who have had a cut-through hysterectomy, compared stage for stage with patients who primarily received a radical procedure with negative margins or primary chemotherapy and radiation.⁸ Otherwise said, their risk for death is higher if this error is made. Therefore a thorough examination is essential prior to performing hysterectomy for dysplasia. Any suspicion of bulky cancer should be considered a contraindication for proceeding.
 

Preoperative evaluation

As a rule, no patient should transition directly from cytologic evaluation with Pap screening to hysterectomy. A colposcopic evaluation of the cervix and vagina accompanied with a thorough bimanual rectovaginal examination should always be performed first. Biopsies of the ectocervix and ideally the endocervix should be obtained because the accuracy of histology is greater than that of cytology. For patients with cervical intraepithelial neoplasia stage I lesions, hysterectomy is not appropriate, as these patients have an extremely low risk for the development of cervical cancer, and the risks and costs of hysterectomy are not justified in such a population.

Surgeons should wait at least 6 weeks following conization or LEEP before performing hysterectomy in order to minimize the likelihood of perioperative complications.⁹

Substituting LEEP or cone with hysterectomy

In general, it is the most prudent approach to first perform a diagnostic excision with LEEP or cone biopsy before proceeding with hysterectomy for definitive surgery. However, there may be some situations in which this is not feasible. In patients whose cervix is very small and flush with the vagina, an excisional procedure may not be technically possible without concern for damage to adjacent structures. In these patients, after a thorough exam has evaluated for gross disease, a hysterectomy may be the only way to adequately diagnose and treat high-grade dysplasia through excision. For patients with limited access to resources, transportation, or a concern for noncompliance with follow-up, surgeons may wish to offer patients primary hysterectomy rather than a staged procedure.

Hysterectomy remains a potential option for treatment of cervical dysplasia. However, patients should be made aware of the risks of undertreatment of occult cancers, the need for long-term surveillance testing, and the risk for future vaginal dysplasia or cancer. Ideally a comprehensive, stepwise assessment from cytology to colposcopy and examination to diagnostic excisional procedure will first take place to proceed safely with this approach.

References

1. Saslow D et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72.

2. Schockaert S et al. Incidence of vaginal intraepithelial neoplasia after hysterectomy for cervical intraepithelial neoplasia: a retrospective study. Am J Obstet Gynecol. 2008 Aug;199(2):113.e1-5.

3. Kalogirou D et al. Vaginal intraepithelial neoplasia (VAIN) following hysterectomy in patients treated for carcinoma in situ of the cervix. Eur J Gynaecol Oncol. 1997;18(3):188-91.

4. Landy R et al. Evaluating cytology for the detection of invasive cervical cancer. Cytopathology. 2016 Jun;27(3):201-9.

5. Latif NA et al. Management of adenocarcinoma in situ of the uterine cervix: a comparison of loop electrosurgical excision procedure and cold knife conization. J Low Genit Tract Dis. 2015 Apr;19(2):97-102.

6. Bai H et al. The potential for less radical surgery in women with stage IA2-IB1 cervical cancer. Int J Gynaecol Obstet. 2015 Sep;130(3):235-40.

7. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Version 2.2018. 2018 Jun 26.

8. Barber HR et al. Operative management of patients previously operated upon for a benign lesion with cervical cancer as a surprise finding. Am J Obstet Gynecol. 1968 Aug 1;101(7):959-65.

9. Sullivan SA et al. Association between timing of cervical excision procedure to minimally invasive hysterectomy and surgical complications. Gynecol Oncol. 2017 Feb;144(2):294-298.

Cervical dysplasia is commonly diagnosed in women who have completed childbearing and don’t desire future fertility. While diagnostic and/or definitive therapy for cervical dysplasia can include hysterectomy, there are important considerations to make when offering this procedure to patients.

Pitfalls

Hysterectomy is commonly requested by patients upon learning of cervical dysplasia, particularly if they have chronic human papillomavirus (HPV) infection and have experienced years of frequent surveillance and interventions. They may see hysterectomy as an option to avoid this close surveillance and to be free of their dysplasia. There are two main concerns with offering hysterectomy as the primary surgical option for the management of dysplasia. Firstly, it may not be curative, and secondly, it may be an inadequate excisional procedure, particularly if the patient has occult invasive disease that has not been adequately diagnosed with a loop electrosurgical excision procedure (LEEP) or a cone biopsy procedure.

It is important to counsel these patients that surgery is not a treatment for high-risk HPV infection, which is the underlying etiology of their disease. With that etiology, HPV infection is likely to persist after hysterectomy and they may develop vaginal or vulvar dysplasia. Therefore, the American Society for Colposcopy and Cervical Pathology recommends that cytology and/or high-risk HPV surveillance continue following hysterectomy if that surgery was performed for dysplasia.¹ Hysterectomy is not a means to avoid years of surveillance testing. Approximately 10% of women who have hysterectomy for cervical dysplasia develop vaginal dysplasia or cancer after surgery.^2,3 This is similar to the likelihood of recurrent dysplasia after an alternative excisional procedure. In my experience, this diagnosis is often met with enormous frustration for the patient who thought that her hysterectomy would be the cure of her HPV-related disease. Thorough colposcopic evaluation of the vagina can be technically challenging after hysterectomy because of difficulty adequately visualizing lesions within the vaginal rugations, particularly within the puckered lateral vaginal fornices, the most common location for dysplasia.³ We will explore the diagnosis and treatment options for vaginal dysplasia further in a future column.

It is critical that, if patients are offered hysterectomy for treatment of cervical dysplasia, they are counseled that it may not be curative, that they will require long-term vaginal surveillance, and that they are at continued risk for vaginal and vulvar cancer.

An additional concern with performing hysterectomy for definitive management of cervical dysplasia is the concern that occult cancer may be missed preoperatively, and that the hysterectomy is inadequate surgical clearance of the disease. Approximately 2%-5% of patients with a high-grade squamous intraepithelial lesion or equivocal Pap test have occult cervical cancer.⁴ A similar proportion of patients with cervical intraepithelial neoplasia stage III or adenocarcinoma in situ on colposcopy biopsy have invasive carcinoma on evaluation of an excisional specimen.⁵ The traditional surgical approach has dictated that a modified (type II) or extended (type III) radical hysterectomy be performed in the setting of FIGO stage IA2 or greater cervical cancer. Radical hysterectomies remove parametrial tissue, effectively achieving a wider margin around the primary lesion. This is important because cervical cancer primarily spreads via direct extension.

The appropriate radicality of surgery for microscopic lesions is debated. It has been proposed that for very small, low-risk lesions, a traditional extrafascial hysterectomy or trachelectomy, or possibly even a large conization, may be adequate.⁶ However, this is controversial, and National Comprehensive Cancer Network guidelines still advocate for radical procedures for these lesions.⁷ Certainly an excisional procedure (LEEP or cone) should first be performed to define the size and histologic features of the lesion, and ideally, evaluation and counseling with a gynecologic oncologist should be performed prior to offering patients with a stage IA2 or greater lesion an extrafascial hysterectomy. Additionally, a separate decision would need to be made regarding the need for lymphadenectomy, as this is typically recommended for patients with stage IA2 or greater lesions.

Patients should be counseled that, if extrafascial (simple) hysterectomy is chosen as the primary excisional procedure, they may require additional therapy (additional surgery, or radiation and possibly chemotherapy) if cancer is found in the specimen and the parametrial margin is inadequate. Additionally, and of more concern, if the lesion is a bulky lesion extending into the parametrium and not recognized preoperatively, a “cut-through” hysterectomy will be inadvertently performed (in which margins are grossly positive). These situations typically feature heavy blood loss with patients at increased risk for immediate surgical complications. Postoperatively, prognosis is substantially worse for patients who have had a cut-through hysterectomy, compared stage for stage with patients who primarily received a radical procedure with negative margins or primary chemotherapy and radiation.⁸ Otherwise said, their risk for death is higher if this error is made. Therefore a thorough examination is essential prior to performing hysterectomy for dysplasia. Any suspicion of bulky cancer should be considered a contraindication for proceeding.
 

Preoperative evaluation

As a rule, no patient should transition directly from cytologic evaluation with Pap screening to hysterectomy. A colposcopic evaluation of the cervix and vagina accompanied with a thorough bimanual rectovaginal examination should always be performed first. Biopsies of the ectocervix and ideally the endocervix should be obtained because the accuracy of histology is greater than that of cytology. For patients with cervical intraepithelial neoplasia stage I lesions, hysterectomy is not appropriate, as these patients have an extremely low risk for the development of cervical cancer, and the risks and costs of hysterectomy are not justified in such a population.

Surgeons should wait at least 6 weeks following conization or LEEP before performing hysterectomy in order to minimize the likelihood of perioperative complications.⁹

Substituting LEEP or cone with hysterectomy

In general, it is the most prudent approach to first perform a diagnostic excision with LEEP or cone biopsy before proceeding with hysterectomy for definitive surgery. However, there may be some situations in which this is not feasible. In patients whose cervix is very small and flush with the vagina, an excisional procedure may not be technically possible without concern for damage to adjacent structures. In these patients, after a thorough exam has evaluated for gross disease, a hysterectomy may be the only way to adequately diagnose and treat high-grade dysplasia through excision. For patients with limited access to resources, transportation, or a concern for noncompliance with follow-up, surgeons may wish to offer patients primary hysterectomy rather than a staged procedure.

Hysterectomy remains a potential option for treatment of cervical dysplasia. However, patients should be made aware of the risks of undertreatment of occult cancers, the need for long-term surveillance testing, and the risk for future vaginal dysplasia or cancer. Ideally a comprehensive, stepwise assessment from cytology to colposcopy and examination to diagnostic excisional procedure will first take place to proceed safely with this approach.

References

1. Saslow D et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72.

2. Schockaert S et al. Incidence of vaginal intraepithelial neoplasia after hysterectomy for cervical intraepithelial neoplasia: a retrospective study. Am J Obstet Gynecol. 2008 Aug;199(2):113.e1-5.

3. Kalogirou D et al. Vaginal intraepithelial neoplasia (VAIN) following hysterectomy in patients treated for carcinoma in situ of the cervix. Eur J Gynaecol Oncol. 1997;18(3):188-91.

4. Landy R et al. Evaluating cytology for the detection of invasive cervical cancer. Cytopathology. 2016 Jun;27(3):201-9.

5. Latif NA et al. Management of adenocarcinoma in situ of the uterine cervix: a comparison of loop electrosurgical excision procedure and cold knife conization. J Low Genit Tract Dis. 2015 Apr;19(2):97-102.

6. Bai H et al. The potential for less radical surgery in women with stage IA2-IB1 cervical cancer. Int J Gynaecol Obstet. 2015 Sep;130(3):235-40.

7. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Version 2.2018. 2018 Jun 26.

8. Barber HR et al. Operative management of patients previously operated upon for a benign lesion with cervical cancer as a surprise finding. Am J Obstet Gynecol. 1968 Aug 1;101(7):959-65.

9. Sullivan SA et al. Association between timing of cervical excision procedure to minimally invasive hysterectomy and surgical complications. Gynecol Oncol. 2017 Feb;144(2):294-298.

Applications are due by Aug. 2 for the SVS International Scholars Program, which provides up to four scholarships to qualified young vascular surgeons from countries other than the United States or Canada. Awardees receive $5,000 each, to attend the 2019 Vascular Annual Meeting and to visit clinical, teaching and research facilities in the U.S. and Canada.

Applications are due by Aug. 2 for the SVS International Scholars Program, which provides up to four scholarships to qualified young vascular surgeons from countries other than the United States or Canada. Awardees receive $5,000 each, to attend the 2019 Vascular Annual Meeting and to visit clinical, teaching and research facilities in the U.S. and Canada.

Applications are due by Aug. 2 for the SVS International Scholars Program, which provides up to four scholarships to qualified young vascular surgeons from countries other than the United States or Canada. Awardees receive $5,000 each, to attend the 2019 Vascular Annual Meeting and to visit clinical, teaching and research facilities in the U.S. and Canada.

Picture this: Creating visual representations of symptom clusters may help oncologists identify and treat sentinel symptoms in patients who are receiving cancer therapies and potentially avoid costly and unnecessary acute hospitalizations.

Network visualizations – graphic representations of the frequency of individual symptoms and the strength of their co-occurrence with other symptoms – could be used by clinicians in urgent-care settings to determine whether a presenting symptom or cluster of symptoms could be safely managed in the outpatient setting or requires hospitalization, according to Bobby Daly, MD, and his colleagues at Memorial Sloan Kettering Cancer Center in New York.

“Uncontrolled symptoms are associated with unplanned acute care. Recognition of the complexity of symptom co-occurrence can drive improved management strategies,” the investigators wrote. The report was published in the Journal of Oncology Practice.

Preventing hospitalizations related to treatment toxicities is both sound clinical and financial practice.

“Patients who receive chemotherapy have, on average, one hospital admission and two emergency department visits per year, and 40%-50% of these stem from symptoms related to their treatment. Acute hospitalizations account for 48% of total cancer expenditures. Considerable regional variation exists, which suggests that these hospitalizations may be avoidable,” they wrote.

The Centers for Medicare & Medicaid Services has identified 10 potentially preventable conditions that may result in hospitalizations, and plans to measure the performance of cancer centers based on the frequency of urgent care visits and admissions for each condition.

The conditions (in alphabetical order) are: anemia, dehydration, diarrhea, emesis, fever, nausea, neutropenia, pain, pneumonia, and sepsis.

To get a better handle on symptom clusters in patients undergoing active cancer therapy, the investigators used an analytical method involving creation of network visualizations of symptom clusters.

“It has been established that physicians are uncomfortable with managing symptom clusters, and by better elucidating these clusters, we can improve management strategies,” Dr. Daly and his associates wrote.

They identified 23,341 unique patient visits to their center’s urgent care department in 2016, and included in their analysis only those patients who had received an intravenous chemotherapy agent, oral antineoplastic therapy, or immunotherapy within 30 days of presentation. They drew on the electronic health record (EHR) for information about the chief complaint and primary diagnosis for each visit.

They then created three patient cohorts for identifying and mapping potentially preventable symptom clusters.

Cohort 1 comprised patients who were receiving active treatment and presented to the urgent care center with one of the CMS-defined symptoms.

Cohort 2 comprised patients who were receiving active treatment and were evaluated with a clinician-developed definition of a potentially preventable symptom, defined as “a symptom that could be managed safely in the outpatient setting if the clinical team identified said symptom early and managed it proactively.”

Cohort 3 was similar to cohort 2, but included only those patients who started treatment for the first time.

The authors identified 6,429 presentations in cohort 1, and in this group of patients the network analysis identified two distinct symptom clusters centered around pain and fever.

In cohort 2, there were 5,731 visits and six symptom clusters centered around fever, nausea/emesis, fatigue, deep vein thrombosis, pain, and ascites.

In cohort 3, there were 1,154 visits and four symptom clusters centered around fever, nausea/emesis, fatigue, and deep vein thrombosis.

“By using EHR data fields for [urgent care center] primary diagnoses and chief complaints, we elicited symptom information and linked it to unplanned acute care. Unplanned acute care is of increasing importance to patients because it disrupts patients’ treatment trajectories as well as their lives outside the clinic. Use of the EHR also allowed for granular symptom data, such as a particular site of pain rather than just pain itself, which is absent from traditional sources of patient-reported symptom assessments,” Dr. Daly and his colleagues said.

The investigators recommend using data from the EHR in combination with “big data” artificial intelligence techniques to allow early detection of patients at risk for symptom clusters.

The study was supported by an ASCO Health Policy Fellowship to Dr. Daly. He disclosed employment and stock ownership with Quadrant Holdings Corporation, and stock ownership in CVS Health, Johnson & Johnson, McKesson, Lilly and the Walgreens Boots Alliance.

SOURCE: Daly B et al. J Oncol Practice, 2018 Jul 17. doi: 10.1200/JOP.18.00199.

Picture this: Creating visual representations of symptom clusters may help oncologists identify and treat sentinel symptoms in patients who are receiving cancer therapies and potentially avoid costly and unnecessary acute hospitalizations.

Network visualizations – graphic representations of the frequency of individual symptoms and the strength of their co-occurrence with other symptoms – could be used by clinicians in urgent-care settings to determine whether a presenting symptom or cluster of symptoms could be safely managed in the outpatient setting or requires hospitalization, according to Bobby Daly, MD, and his colleagues at Memorial Sloan Kettering Cancer Center in New York.

“Uncontrolled symptoms are associated with unplanned acute care. Recognition of the complexity of symptom co-occurrence can drive improved management strategies,” the investigators wrote. The report was published in the Journal of Oncology Practice.

Preventing hospitalizations related to treatment toxicities is both sound clinical and financial practice.

“Patients who receive chemotherapy have, on average, one hospital admission and two emergency department visits per year, and 40%-50% of these stem from symptoms related to their treatment. Acute hospitalizations account for 48% of total cancer expenditures. Considerable regional variation exists, which suggests that these hospitalizations may be avoidable,” they wrote.

The Centers for Medicare & Medicaid Services has identified 10 potentially preventable conditions that may result in hospitalizations, and plans to measure the performance of cancer centers based on the frequency of urgent care visits and admissions for each condition.

The conditions (in alphabetical order) are: anemia, dehydration, diarrhea, emesis, fever, nausea, neutropenia, pain, pneumonia, and sepsis.

To get a better handle on symptom clusters in patients undergoing active cancer therapy, the investigators used an analytical method involving creation of network visualizations of symptom clusters.

“It has been established that physicians are uncomfortable with managing symptom clusters, and by better elucidating these clusters, we can improve management strategies,” Dr. Daly and his associates wrote.

They identified 23,341 unique patient visits to their center’s urgent care department in 2016, and included in their analysis only those patients who had received an intravenous chemotherapy agent, oral antineoplastic therapy, or immunotherapy within 30 days of presentation. They drew on the electronic health record (EHR) for information about the chief complaint and primary diagnosis for each visit.

They then created three patient cohorts for identifying and mapping potentially preventable symptom clusters.

Cohort 1 comprised patients who were receiving active treatment and presented to the urgent care center with one of the CMS-defined symptoms.

Cohort 2 comprised patients who were receiving active treatment and were evaluated with a clinician-developed definition of a potentially preventable symptom, defined as “a symptom that could be managed safely in the outpatient setting if the clinical team identified said symptom early and managed it proactively.”

Cohort 3 was similar to cohort 2, but included only those patients who started treatment for the first time.

The authors identified 6,429 presentations in cohort 1, and in this group of patients the network analysis identified two distinct symptom clusters centered around pain and fever.

In cohort 2, there were 5,731 visits and six symptom clusters centered around fever, nausea/emesis, fatigue, deep vein thrombosis, pain, and ascites.

In cohort 3, there were 1,154 visits and four symptom clusters centered around fever, nausea/emesis, fatigue, and deep vein thrombosis.

“By using EHR data fields for [urgent care center] primary diagnoses and chief complaints, we elicited symptom information and linked it to unplanned acute care. Unplanned acute care is of increasing importance to patients because it disrupts patients’ treatment trajectories as well as their lives outside the clinic. Use of the EHR also allowed for granular symptom data, such as a particular site of pain rather than just pain itself, which is absent from traditional sources of patient-reported symptom assessments,” Dr. Daly and his colleagues said.

The investigators recommend using data from the EHR in combination with “big data” artificial intelligence techniques to allow early detection of patients at risk for symptom clusters.

The study was supported by an ASCO Health Policy Fellowship to Dr. Daly. He disclosed employment and stock ownership with Quadrant Holdings Corporation, and stock ownership in CVS Health, Johnson & Johnson, McKesson, Lilly and the Walgreens Boots Alliance.

SOURCE: Daly B et al. J Oncol Practice, 2018 Jul 17. doi: 10.1200/JOP.18.00199.

Picture this: Creating visual representations of symptom clusters may help oncologists identify and treat sentinel symptoms in patients who are receiving cancer therapies and potentially avoid costly and unnecessary acute hospitalizations.

Network visualizations – graphic representations of the frequency of individual symptoms and the strength of their co-occurrence with other symptoms – could be used by clinicians in urgent-care settings to determine whether a presenting symptom or cluster of symptoms could be safely managed in the outpatient setting or requires hospitalization, according to Bobby Daly, MD, and his colleagues at Memorial Sloan Kettering Cancer Center in New York.

“Uncontrolled symptoms are associated with unplanned acute care. Recognition of the complexity of symptom co-occurrence can drive improved management strategies,” the investigators wrote. The report was published in the Journal of Oncology Practice.

Preventing hospitalizations related to treatment toxicities is both sound clinical and financial practice.

“Patients who receive chemotherapy have, on average, one hospital admission and two emergency department visits per year, and 40%-50% of these stem from symptoms related to their treatment. Acute hospitalizations account for 48% of total cancer expenditures. Considerable regional variation exists, which suggests that these hospitalizations may be avoidable,” they wrote.

The Centers for Medicare & Medicaid Services has identified 10 potentially preventable conditions that may result in hospitalizations, and plans to measure the performance of cancer centers based on the frequency of urgent care visits and admissions for each condition.

The conditions (in alphabetical order) are: anemia, dehydration, diarrhea, emesis, fever, nausea, neutropenia, pain, pneumonia, and sepsis.

To get a better handle on symptom clusters in patients undergoing active cancer therapy, the investigators used an analytical method involving creation of network visualizations of symptom clusters.

“It has been established that physicians are uncomfortable with managing symptom clusters, and by better elucidating these clusters, we can improve management strategies,” Dr. Daly and his associates wrote.

They identified 23,341 unique patient visits to their center’s urgent care department in 2016, and included in their analysis only those patients who had received an intravenous chemotherapy agent, oral antineoplastic therapy, or immunotherapy within 30 days of presentation. They drew on the electronic health record (EHR) for information about the chief complaint and primary diagnosis for each visit.

They then created three patient cohorts for identifying and mapping potentially preventable symptom clusters.

Cohort 1 comprised patients who were receiving active treatment and presented to the urgent care center with one of the CMS-defined symptoms.

Cohort 2 comprised patients who were receiving active treatment and were evaluated with a clinician-developed definition of a potentially preventable symptom, defined as “a symptom that could be managed safely in the outpatient setting if the clinical team identified said symptom early and managed it proactively.”

Cohort 3 was similar to cohort 2, but included only those patients who started treatment for the first time.

The authors identified 6,429 presentations in cohort 1, and in this group of patients the network analysis identified two distinct symptom clusters centered around pain and fever.

In cohort 2, there were 5,731 visits and six symptom clusters centered around fever, nausea/emesis, fatigue, deep vein thrombosis, pain, and ascites.

In cohort 3, there were 1,154 visits and four symptom clusters centered around fever, nausea/emesis, fatigue, and deep vein thrombosis.

“By using EHR data fields for [urgent care center] primary diagnoses and chief complaints, we elicited symptom information and linked it to unplanned acute care. Unplanned acute care is of increasing importance to patients because it disrupts patients’ treatment trajectories as well as their lives outside the clinic. Use of the EHR also allowed for granular symptom data, such as a particular site of pain rather than just pain itself, which is absent from traditional sources of patient-reported symptom assessments,” Dr. Daly and his colleagues said.

The investigators recommend using data from the EHR in combination with “big data” artificial intelligence techniques to allow early detection of patients at risk for symptom clusters.

The study was supported by an ASCO Health Policy Fellowship to Dr. Daly. He disclosed employment and stock ownership with Quadrant Holdings Corporation, and stock ownership in CVS Health, Johnson & Johnson, McKesson, Lilly and the Walgreens Boots Alliance.

SOURCE: Daly B et al. J Oncol Practice, 2018 Jul 17. doi: 10.1200/JOP.18.00199.

Molecular analysis showed that a Liberian woman who survived Ebola virus disease in 2014 had viral persistence or recurrent disease and transmitted the virus to other family members a year later, according to a study published online in The Lancet Infectious Diseases.

CDC/Athalia Christie

Although the original 2014-2015 Ebola virus disease epidemic in West Africa had been contained, subsequent clusters of infection continued to occur in the region, according to researchers. A particular cluster in Liberia in November 2015 was identified after a 15-year-old boy in Monrovia tested positive.

Based on serology and epidemiological and genomic data, the researchers concluded that this cluster was caused by a woman who survived Ebola virus disease in 2014 and transmitted the virus to three family members a year later.

Ebola transmission from persistently infected male survivors is well documented, but this is the first confirmed evidence for Ebola transmission from a persistently infected female survivor, according to Emily Kainne Dokubo, MD, of the Centers for Disease Control and Prevention and her colleagues.

“The findings from this and recent Ebola virus disease clusters highlight the risk of Ebola virus disease flare-ups even after an outbreak is declared over. Risk assessment and focused prevention efforts are needed for Ebola survivors and their close contacts,” Dr. Dokubo and her colleagues concluded.

The study was funded by the CDC, Defense Threat Reduction Agency, and WHO.

[email protected]

SOURCE: Dokubo EK et al. The Lancet Infectious Diseases, July 23, 2018.

Molecular analysis showed that a Liberian woman who survived Ebola virus disease in 2014 had viral persistence or recurrent disease and transmitted the virus to other family members a year later, according to a study published online in The Lancet Infectious Diseases.

CDC/Athalia Christie

Although the original 2014-2015 Ebola virus disease epidemic in West Africa had been contained, subsequent clusters of infection continued to occur in the region, according to researchers. A particular cluster in Liberia in November 2015 was identified after a 15-year-old boy in Monrovia tested positive.

Based on serology and epidemiological and genomic data, the researchers concluded that this cluster was caused by a woman who survived Ebola virus disease in 2014 and transmitted the virus to three family members a year later.

Ebola transmission from persistently infected male survivors is well documented, but this is the first confirmed evidence for Ebola transmission from a persistently infected female survivor, according to Emily Kainne Dokubo, MD, of the Centers for Disease Control and Prevention and her colleagues.

“The findings from this and recent Ebola virus disease clusters highlight the risk of Ebola virus disease flare-ups even after an outbreak is declared over. Risk assessment and focused prevention efforts are needed for Ebola survivors and their close contacts,” Dr. Dokubo and her colleagues concluded.

The study was funded by the CDC, Defense Threat Reduction Agency, and WHO.

[email protected]

SOURCE: Dokubo EK et al. The Lancet Infectious Diseases, July 23, 2018.

Molecular analysis showed that a Liberian woman who survived Ebola virus disease in 2014 had viral persistence or recurrent disease and transmitted the virus to other family members a year later, according to a study published online in The Lancet Infectious Diseases.

CDC/Athalia Christie

Although the original 2014-2015 Ebola virus disease epidemic in West Africa had been contained, subsequent clusters of infection continued to occur in the region, according to researchers. A particular cluster in Liberia in November 2015 was identified after a 15-year-old boy in Monrovia tested positive.

Based on serology and epidemiological and genomic data, the researchers concluded that this cluster was caused by a woman who survived Ebola virus disease in 2014 and transmitted the virus to three family members a year later.

Ebola transmission from persistently infected male survivors is well documented, but this is the first confirmed evidence for Ebola transmission from a persistently infected female survivor, according to Emily Kainne Dokubo, MD, of the Centers for Disease Control and Prevention and her colleagues.

“The findings from this and recent Ebola virus disease clusters highlight the risk of Ebola virus disease flare-ups even after an outbreak is declared over. Risk assessment and focused prevention efforts are needed for Ebola survivors and their close contacts,” Dr. Dokubo and her colleagues concluded.

The study was funded by the CDC, Defense Threat Reduction Agency, and WHO.

[email protected]

SOURCE: Dokubo EK et al. The Lancet Infectious Diseases, July 23, 2018.

The regulation of food additives needs an overhaul in the United States because of the risks these compounds pose to children and infants, according to a new policy statement by the American Academy of Pediatrics.

namiroz/iStock/Getty Images

Health care providers can offer the parents of patients some practical suggestions to reduce exposure to some of the greatest food additive offenders, suggested members of the AAP Council on Environmental Health.

Among the additives of greatest concern, the statement notes, are bisphenols (including bisphenol A), phthalates, certain pesticides, perfluoroalkyl chemicals, perchlorate, artificial food colors, nitrates, and nitrites. A technical report accompanying the policy statement reviewed existing evidence on these compounds.

The statement, authored by the council led by Leonardo Trasande, MD, of New York University, noted that many of the more than 10,000 chemicals added to food and food packaging were grandfathered into use prior to current regulations. Further, approximately 1,000 of these chemicals fall under the Food and Drug Administration’s designation of “generally recognized as safe,” which does not require FDA approval for use.

“Current requirements for a ‘generally recognized as safe’ [GRAS] designation are insufficient to ensure the safety of food additives and do not contain sufficient protections against conflict of interest,” they wrote. “Additionally, the FDA does not have authority to obtain data on or reassess the safety of chemicals already on the market.” The FDA does not regularly consider cumulative effects of food additives or the synergistic effects of chemicals found in foods.

The authors noted that concerns about food additives have increased in the past 20 years as new research has identified adverse health effects, including endocrine disruption, associated with these chemicals.

Dr. Trasande and his associates also acknowledged the limited evidence available on food additives particularly for children and infants, but noted this population’s greater vulnerability to chemical exposures.
 

Compounds addressed in the statement

• Bisphenols. Health concerns tied to these chemicals are endocrine/neurodevelopmental disruption and obesogenic activity.
• Phthalates. Health concerns linked to these chemicals are endocrine disruption, obesogenic activity, oxidative stress, and cardiotoxicity.
• Perfluoroalkyl chemicals. Health concerns associated with these chemicals are immunosuppression, endocrine disruption, obesogenic activity, and decreased birth weight.
• Perchlorate. The health concern tied to this chemical is thyroid hormone disruption.
• Nitrates and nitrites. Use of these as a preservative and color enhancer has been linked to carcinogenicity and thyroid hormone disruption.

Of these, only nitrates and nitrites are directly added to food while the other chemicals are indirect additives via their use in food packaging that directly touches the food.

How health care providers can help parents and children

“Insofar as these modifications can pose additional costs, barriers may exist for low-income families to reduce their exposure to food additives of concern,” the authors wrote. Health care providers “may wish to tailor guidance in the context of practicality, especially because food insecurity remains a substantial child health concern.”

Their recommendations on guidance for parents include:

• Prioritize fresh or frozen vegetables in meals. “Develop a list of low-cost sources for fresh fruits and vegetables” in the area.
• Avoid processed meats (particularly for mothers during pregnancy).
• Avoid microwaving food in plastic. This includes infant formula and pumped human milk.
• Avoid washing plastics in the dishwasher.
• Use plastic alternatives such as glass or stainless steel.
• Encourage both hand-washing and washing all fruits and vegetables.
• Look at recycling codes on products and avoid plastics with codes 3 (phthalates), 6 (styrene), and 7 (bisphenols) unless labeled as “biobased” or “greenware.”

The statement also encourages health care providers to advocate for updating and strengthening the Toxic Substances Control Act.

The committee also made multiple recommendations for government.

Dr. Trasande and coauthor Rachel M. Shaffer, MPH, received funding from some National Institutes of Health grants. The authors had no relevant financial disclosures.

SOURCES: Trasande L et al. Pediatrics. 2018 Jun 23. doi: 10.1542/peds.2018-1408; doi: 10.1542/ peds. 2018-1410.

The regulation of food additives needs an overhaul in the United States because of the risks these compounds pose to children and infants, according to a new policy statement by the American Academy of Pediatrics.

namiroz/iStock/Getty Images

Health care providers can offer the parents of patients some practical suggestions to reduce exposure to some of the greatest food additive offenders, suggested members of the AAP Council on Environmental Health.

Among the additives of greatest concern, the statement notes, are bisphenols (including bisphenol A), phthalates, certain pesticides, perfluoroalkyl chemicals, perchlorate, artificial food colors, nitrates, and nitrites. A technical report accompanying the policy statement reviewed existing evidence on these compounds.

The statement, authored by the council led by Leonardo Trasande, MD, of New York University, noted that many of the more than 10,000 chemicals added to food and food packaging were grandfathered into use prior to current regulations. Further, approximately 1,000 of these chemicals fall under the Food and Drug Administration’s designation of “generally recognized as safe,” which does not require FDA approval for use.

“Current requirements for a ‘generally recognized as safe’ [GRAS] designation are insufficient to ensure the safety of food additives and do not contain sufficient protections against conflict of interest,” they wrote. “Additionally, the FDA does not have authority to obtain data on or reassess the safety of chemicals already on the market.” The FDA does not regularly consider cumulative effects of food additives or the synergistic effects of chemicals found in foods.

The authors noted that concerns about food additives have increased in the past 20 years as new research has identified adverse health effects, including endocrine disruption, associated with these chemicals.

Dr. Trasande and his associates also acknowledged the limited evidence available on food additives particularly for children and infants, but noted this population’s greater vulnerability to chemical exposures.
 

Compounds addressed in the statement

• Bisphenols. Health concerns tied to these chemicals are endocrine/neurodevelopmental disruption and obesogenic activity.
• Phthalates. Health concerns linked to these chemicals are endocrine disruption, obesogenic activity, oxidative stress, and cardiotoxicity.
• Perfluoroalkyl chemicals. Health concerns associated with these chemicals are immunosuppression, endocrine disruption, obesogenic activity, and decreased birth weight.
• Perchlorate. The health concern tied to this chemical is thyroid hormone disruption.
• Nitrates and nitrites. Use of these as a preservative and color enhancer has been linked to carcinogenicity and thyroid hormone disruption.

Of these, only nitrates and nitrites are directly added to food while the other chemicals are indirect additives via their use in food packaging that directly touches the food.

How health care providers can help parents and children

“Insofar as these modifications can pose additional costs, barriers may exist for low-income families to reduce their exposure to food additives of concern,” the authors wrote. Health care providers “may wish to tailor guidance in the context of practicality, especially because food insecurity remains a substantial child health concern.”

Their recommendations on guidance for parents include:

• Prioritize fresh or frozen vegetables in meals. “Develop a list of low-cost sources for fresh fruits and vegetables” in the area.
• Avoid processed meats (particularly for mothers during pregnancy).
• Avoid microwaving food in plastic. This includes infant formula and pumped human milk.
• Avoid washing plastics in the dishwasher.
• Use plastic alternatives such as glass or stainless steel.
• Encourage both hand-washing and washing all fruits and vegetables.
• Look at recycling codes on products and avoid plastics with codes 3 (phthalates), 6 (styrene), and 7 (bisphenols) unless labeled as “biobased” or “greenware.”

The statement also encourages health care providers to advocate for updating and strengthening the Toxic Substances Control Act.

The committee also made multiple recommendations for government.

Dr. Trasande and coauthor Rachel M. Shaffer, MPH, received funding from some National Institutes of Health grants. The authors had no relevant financial disclosures.

SOURCES: Trasande L et al. Pediatrics. 2018 Jun 23. doi: 10.1542/peds.2018-1408; doi: 10.1542/ peds. 2018-1410.

The regulation of food additives needs an overhaul in the United States because of the risks these compounds pose to children and infants, according to a new policy statement by the American Academy of Pediatrics.

namiroz/iStock/Getty Images

Health care providers can offer the parents of patients some practical suggestions to reduce exposure to some of the greatest food additive offenders, suggested members of the AAP Council on Environmental Health.

Among the additives of greatest concern, the statement notes, are bisphenols (including bisphenol A), phthalates, certain pesticides, perfluoroalkyl chemicals, perchlorate, artificial food colors, nitrates, and nitrites. A technical report accompanying the policy statement reviewed existing evidence on these compounds.

The statement, authored by the council led by Leonardo Trasande, MD, of New York University, noted that many of the more than 10,000 chemicals added to food and food packaging were grandfathered into use prior to current regulations. Further, approximately 1,000 of these chemicals fall under the Food and Drug Administration’s designation of “generally recognized as safe,” which does not require FDA approval for use.

“Current requirements for a ‘generally recognized as safe’ [GRAS] designation are insufficient to ensure the safety of food additives and do not contain sufficient protections against conflict of interest,” they wrote. “Additionally, the FDA does not have authority to obtain data on or reassess the safety of chemicals already on the market.” The FDA does not regularly consider cumulative effects of food additives or the synergistic effects of chemicals found in foods.

The authors noted that concerns about food additives have increased in the past 20 years as new research has identified adverse health effects, including endocrine disruption, associated with these chemicals.

Dr. Trasande and his associates also acknowledged the limited evidence available on food additives particularly for children and infants, but noted this population’s greater vulnerability to chemical exposures.
 

Compounds addressed in the statement

• Bisphenols. Health concerns tied to these chemicals are endocrine/neurodevelopmental disruption and obesogenic activity.
• Phthalates. Health concerns linked to these chemicals are endocrine disruption, obesogenic activity, oxidative stress, and cardiotoxicity.
• Perfluoroalkyl chemicals. Health concerns associated with these chemicals are immunosuppression, endocrine disruption, obesogenic activity, and decreased birth weight.
• Perchlorate. The health concern tied to this chemical is thyroid hormone disruption.
• Nitrates and nitrites. Use of these as a preservative and color enhancer has been linked to carcinogenicity and thyroid hormone disruption.

Of these, only nitrates and nitrites are directly added to food while the other chemicals are indirect additives via their use in food packaging that directly touches the food.

How health care providers can help parents and children

“Insofar as these modifications can pose additional costs, barriers may exist for low-income families to reduce their exposure to food additives of concern,” the authors wrote. Health care providers “may wish to tailor guidance in the context of practicality, especially because food insecurity remains a substantial child health concern.”

Their recommendations on guidance for parents include:

• Prioritize fresh or frozen vegetables in meals. “Develop a list of low-cost sources for fresh fruits and vegetables” in the area.
• Avoid processed meats (particularly for mothers during pregnancy).
• Avoid microwaving food in plastic. This includes infant formula and pumped human milk.
• Avoid washing plastics in the dishwasher.
• Use plastic alternatives such as glass or stainless steel.
• Encourage both hand-washing and washing all fruits and vegetables.
• Look at recycling codes on products and avoid plastics with codes 3 (phthalates), 6 (styrene), and 7 (bisphenols) unless labeled as “biobased” or “greenware.”

The statement also encourages health care providers to advocate for updating and strengthening the Toxic Substances Control Act.

The committee also made multiple recommendations for government.

Dr. Trasande and coauthor Rachel M. Shaffer, MPH, received funding from some National Institutes of Health grants. The authors had no relevant financial disclosures.

SOURCES: Trasande L et al. Pediatrics. 2018 Jun 23. doi: 10.1542/peds.2018-1408; doi: 10.1542/ peds. 2018-1410.

CHICAGO – The first comprehensive analysis of dementia prevalence among sexual minorities has found a rate of 8% in this population.

While only marginally lower than the 9% prevalence among a heterosexual comparator group, the disorder manifested at an earlier age and occurred more often among men, Jason Flatt, PhD, said at the Alzheimer’s Association International Conference. In addition, higher education didn’t exert the protective influence seen in general populations, said Dr. Flatt of the University of California, San Francisco.

The analysis of a large California health care database is the first step in learning more about dementia in this diverse population, he said. It’s an important quest because the age-risk curve is rising just as quickly among the LGB population as it is in the heterosexual population.

“We do know there are 2-3 million people who identify as LGB [lesbian, gay, or bisexual] in the U.S., and are 60 years old or older, and with the continued aging of our entire population, we expect this number to increase to about 6 million by 2040,” he said. “Given the gaps in collection of sexual orientation and gender identification, we haven’t been able to look at this issue before.”

Sexual minorities face unique dementia risks, Dr. Flatt noted. They are less likely to marry and have children than are heterosexuals, and twice as likely to live alone. “The often have little or no caregiver support, and are likely to have experienced stigma, discrimination, trauma, and high lifelong stress.”

These experiences make the LGB population less likely to seek out medical care, he said. “All of these things impact health over the life course.”

Michele Sullivan/MDedge News

Dr. Flatt and his colleagues drew their data from the Kaiser Permanente Research Program on Genes, Environment, and Health. The study examined dementia prevalence and comorbidities among 4,337 LGB subjects aged 60 years or older, compared with 195,264 age-matched heterosexual subjects. Dementia diagnoses occurred from 1996 to 2015, and the mean follow-up time was 9 years. A quarter of the sample identified as lesbian, 37% identified as gay men, and 38% as bisexual; among these, 48% were women. Depression was more common among the LGB group (35% vs. 28%), as was posttraumatic stress disorder (1.9% vs. 1%). Both are well documented risk factors for dementia.

However, there were no significant difference in other risk factors, including hypertension, stroke, and heart disease, Dr. Flatt noted. He and his associates did not examine midlife obesity, physical inactivity, or low educational attainment, but will do so in a future analysis.

A dementia diagnosis occurred among 343 (8%) of the LGB group and 18,060 (9.2%) of the heterosexual group. The disorder manifested earlier in the LGB group (average 69 vs. 71 years). Self-identified men were overrepresented in the sample (63% vs. 44%) – a key difference, since women are generally found to have a significantly increased risk compared with men. However, Dr. Flatt noted, the study didn’t collect information that would show biological sex, so that number could be skewed.

Higher education didn’t seem to be as protective in the LGB population, with 62% having a college education, compared with 40% of the heterosexual sample.

In a regression analysis that adjusted for age and education, Dr. Flatt reported that depression almost tripled the risk of dementia among sexual minorities (odds ratio, 2.7). Depression was also a significant dementia risk factor for heterosexual subjects (OR, 2.5).

These initial findings highlight the need for more research into this population, he said.

“We need to provide more LGB-affirming health care services, and this means training health care providers to meet these needs.” This might include improved community outreach that could result in earlier detection and treatment, as well as training medical staff to provide more culturally sensitive care.

[email protected]

SOURCE: Flatt J et al. AAIC 2018, Abstract P1-619.

CHICAGO – The first comprehensive analysis of dementia prevalence among sexual minorities has found a rate of 8% in this population.

While only marginally lower than the 9% prevalence among a heterosexual comparator group, the disorder manifested at an earlier age and occurred more often among men, Jason Flatt, PhD, said at the Alzheimer’s Association International Conference. In addition, higher education didn’t exert the protective influence seen in general populations, said Dr. Flatt of the University of California, San Francisco.

The analysis of a large California health care database is the first step in learning more about dementia in this diverse population, he said. It’s an important quest because the age-risk curve is rising just as quickly among the LGB population as it is in the heterosexual population.

“We do know there are 2-3 million people who identify as LGB [lesbian, gay, or bisexual] in the U.S., and are 60 years old or older, and with the continued aging of our entire population, we expect this number to increase to about 6 million by 2040,” he said. “Given the gaps in collection of sexual orientation and gender identification, we haven’t been able to look at this issue before.”

Sexual minorities face unique dementia risks, Dr. Flatt noted. They are less likely to marry and have children than are heterosexuals, and twice as likely to live alone. “The often have little or no caregiver support, and are likely to have experienced stigma, discrimination, trauma, and high lifelong stress.”

These experiences make the LGB population less likely to seek out medical care, he said. “All of these things impact health over the life course.”

Michele Sullivan/MDedge News

Dr. Flatt and his colleagues drew their data from the Kaiser Permanente Research Program on Genes, Environment, and Health. The study examined dementia prevalence and comorbidities among 4,337 LGB subjects aged 60 years or older, compared with 195,264 age-matched heterosexual subjects. Dementia diagnoses occurred from 1996 to 2015, and the mean follow-up time was 9 years. A quarter of the sample identified as lesbian, 37% identified as gay men, and 38% as bisexual; among these, 48% were women. Depression was more common among the LGB group (35% vs. 28%), as was posttraumatic stress disorder (1.9% vs. 1%). Both are well documented risk factors for dementia.

However, there were no significant difference in other risk factors, including hypertension, stroke, and heart disease, Dr. Flatt noted. He and his associates did not examine midlife obesity, physical inactivity, or low educational attainment, but will do so in a future analysis.

A dementia diagnosis occurred among 343 (8%) of the LGB group and 18,060 (9.2%) of the heterosexual group. The disorder manifested earlier in the LGB group (average 69 vs. 71 years). Self-identified men were overrepresented in the sample (63% vs. 44%) – a key difference, since women are generally found to have a significantly increased risk compared with men. However, Dr. Flatt noted, the study didn’t collect information that would show biological sex, so that number could be skewed.

Higher education didn’t seem to be as protective in the LGB population, with 62% having a college education, compared with 40% of the heterosexual sample.

In a regression analysis that adjusted for age and education, Dr. Flatt reported that depression almost tripled the risk of dementia among sexual minorities (odds ratio, 2.7). Depression was also a significant dementia risk factor for heterosexual subjects (OR, 2.5).

These initial findings highlight the need for more research into this population, he said.

“We need to provide more LGB-affirming health care services, and this means training health care providers to meet these needs.” This might include improved community outreach that could result in earlier detection and treatment, as well as training medical staff to provide more culturally sensitive care.

[email protected]

SOURCE: Flatt J et al. AAIC 2018, Abstract P1-619.

CHICAGO – The first comprehensive analysis of dementia prevalence among sexual minorities has found a rate of 8% in this population.

While only marginally lower than the 9% prevalence among a heterosexual comparator group, the disorder manifested at an earlier age and occurred more often among men, Jason Flatt, PhD, said at the Alzheimer’s Association International Conference. In addition, higher education didn’t exert the protective influence seen in general populations, said Dr. Flatt of the University of California, San Francisco.

The analysis of a large California health care database is the first step in learning more about dementia in this diverse population, he said. It’s an important quest because the age-risk curve is rising just as quickly among the LGB population as it is in the heterosexual population.

“We do know there are 2-3 million people who identify as LGB [lesbian, gay, or bisexual] in the U.S., and are 60 years old or older, and with the continued aging of our entire population, we expect this number to increase to about 6 million by 2040,” he said. “Given the gaps in collection of sexual orientation and gender identification, we haven’t been able to look at this issue before.”

Sexual minorities face unique dementia risks, Dr. Flatt noted. They are less likely to marry and have children than are heterosexuals, and twice as likely to live alone. “The often have little or no caregiver support, and are likely to have experienced stigma, discrimination, trauma, and high lifelong stress.”

These experiences make the LGB population less likely to seek out medical care, he said. “All of these things impact health over the life course.”

Michele Sullivan/MDedge News

Dr. Flatt and his colleagues drew their data from the Kaiser Permanente Research Program on Genes, Environment, and Health. The study examined dementia prevalence and comorbidities among 4,337 LGB subjects aged 60 years or older, compared with 195,264 age-matched heterosexual subjects. Dementia diagnoses occurred from 1996 to 2015, and the mean follow-up time was 9 years. A quarter of the sample identified as lesbian, 37% identified as gay men, and 38% as bisexual; among these, 48% were women. Depression was more common among the LGB group (35% vs. 28%), as was posttraumatic stress disorder (1.9% vs. 1%). Both are well documented risk factors for dementia.

However, there were no significant difference in other risk factors, including hypertension, stroke, and heart disease, Dr. Flatt noted. He and his associates did not examine midlife obesity, physical inactivity, or low educational attainment, but will do so in a future analysis.

A dementia diagnosis occurred among 343 (8%) of the LGB group and 18,060 (9.2%) of the heterosexual group. The disorder manifested earlier in the LGB group (average 69 vs. 71 years). Self-identified men were overrepresented in the sample (63% vs. 44%) – a key difference, since women are generally found to have a significantly increased risk compared with men. However, Dr. Flatt noted, the study didn’t collect information that would show biological sex, so that number could be skewed.

Higher education didn’t seem to be as protective in the LGB population, with 62% having a college education, compared with 40% of the heterosexual sample.

In a regression analysis that adjusted for age and education, Dr. Flatt reported that depression almost tripled the risk of dementia among sexual minorities (odds ratio, 2.7). Depression was also a significant dementia risk factor for heterosexual subjects (OR, 2.5).

These initial findings highlight the need for more research into this population, he said.

“We need to provide more LGB-affirming health care services, and this means training health care providers to meet these needs.” This might include improved community outreach that could result in earlier detection and treatment, as well as training medical staff to provide more culturally sensitive care.

[email protected]

SOURCE: Flatt J et al. AAIC 2018, Abstract P1-619.

The symptomatology and severity of fibromyalgia is virtually identical among people with primary and secondary forms of the disorder, researchers say, and the two should therefore be considered the same.

Currently, patients classified as having primary fibromyalgia have a defined set of pain, fatigue, cognitive, and psychological symptoms in the absence of a clinically important inflammatory disorder, while secondary fibromyalgia occurs in the context of a disease such as rheumatoid arthritis.

In research published online in the Journal of Rheumatology, investigators led by Frederick Wolfe, MD, of the National Data Bank for Rheumatic Diseases and the University of Kansas in Wichita, sought to understand whether patients with primary and secondary diagnoses “had the same level of outcomes, symptoms, and characteristics” at different points across the polysymptomatic distress (PSD) scale, a measure to assess severity in fibromyalgia.

The PSD is calculated by combining two measurements used in fibromyalgia: the widespread pain index (WPI), which counts the number of painful regions in the body, and the somatic symptom scale (SSS), which measures fatigue, sleep, emotional and cognitive problems, and the extent of symptom reporting. Higher PSD scores correlate to worse outcomes, including for disability and health-related quality of life.

Dr. Wolfe and his colleagues compared records from 1,525 patients (mean age 57, 95% women) in the National Data Bank who were diagnosed with fibromyalgia only, with those from 12,037 people with rheumatoid arthritis (mean age 61, 82% women) and not evaluated for fibromyalgia. They also looked at data on fibromyalgia symptoms from a general population sample in Germany.

A total of 22% of the RA patients in the cohort met the criteria for a fibromyalgia diagnosis under current (2016) ACR criteria, while 53% of the patients in the primary fibromyalgia group and 2.0% of the general population sample did. Symptom magnitude and severity differed only slightly between the RA and fibromyalgia-only groups, the investigators found. Those without RA had a mean PSD score of 21.9 (of a possible 31) and those with RA and who met the fibromyalgia criteria had a mean score of 20.7.

The researchers found that the disease behaved similarly whether it occurred alone or with RA. Patients with higher PSD scores experienced worse outcomes across symptom domains regardless of RA status. When controlled for PSD, pain, patient global, and health-related quality of life, scores were similar between groups. However, disability scores and painful joint counts were slightly higher in the RA group.

“Fibromyalgia can exist whether or not there’s another disorder present,” Dr. Wolfe said in an interview, “but we don’t tend to think of it that way.” Clinicians, Dr. Wolfe said, “have to be able to identify [fibromyalgia] within other disorders. It can’t be only something that you find once you’ve ruled out everything else.”

Clinicians can look to PSD scores to inform management choices, the researchers said, instead of whether the fibromyalgia is considered primary or secondary.

Dr. Wolfe said that the current bifurcated concept of the disease also creates difficulties for research into fibromyalgia treatments. For example, using RA patients as a comparator group in a clinical trial is problematic because RA patients, as this study demonstrates, also have a substantial burden of fibromyalgia. And the use of so-called healthy controls in fibromyalgia studies is also a problem, Dr. Wolfe said.

“People say they’ve tried this drug or treatment in people with fibromyalgia and on normal controls. But there’s no such thing as normal controls for fibromyalgia. Does normal mean people with zero fatigue or pain? Or do we look at what’s normal among people who have multiple sclerosis or RA? If you’re going to test things in people with fibromyalgia, you never really have normal controls because it depends on where in this whole continuum you are.”

But what this new research also shows, he said, is that while up to now “you couldn’t easily study people with fibromyalgia [in other disorders], it doesn’t matter if you have RA or another disorder in addition to fibromyalgia. You get the full spectrum or severity regardless. The underlying disease wouldn’t affect your identification of the fibromyalgia symptoms.”

Dr. Wolfe and his colleagues described as a limitation of their study the lack of comparator groups besides RA patients. Secondary fibromyalgia is also commonly reported with osteoarthritis, they noted.

The study had no outside funding and investigators reported no conflicts of interest.

SOURCE: Wolfe F et al. J Rheumatol. 2018 Jul 15. doi: 10.3899/jrheum.180083.

The symptomatology and severity of fibromyalgia is virtually identical among people with primary and secondary forms of the disorder, researchers say, and the two should therefore be considered the same.

Currently, patients classified as having primary fibromyalgia have a defined set of pain, fatigue, cognitive, and psychological symptoms in the absence of a clinically important inflammatory disorder, while secondary fibromyalgia occurs in the context of a disease such as rheumatoid arthritis.

In research published online in the Journal of Rheumatology, investigators led by Frederick Wolfe, MD, of the National Data Bank for Rheumatic Diseases and the University of Kansas in Wichita, sought to understand whether patients with primary and secondary diagnoses “had the same level of outcomes, symptoms, and characteristics” at different points across the polysymptomatic distress (PSD) scale, a measure to assess severity in fibromyalgia.

The PSD is calculated by combining two measurements used in fibromyalgia: the widespread pain index (WPI), which counts the number of painful regions in the body, and the somatic symptom scale (SSS), which measures fatigue, sleep, emotional and cognitive problems, and the extent of symptom reporting. Higher PSD scores correlate to worse outcomes, including for disability and health-related quality of life.

Dr. Wolfe and his colleagues compared records from 1,525 patients (mean age 57, 95% women) in the National Data Bank who were diagnosed with fibromyalgia only, with those from 12,037 people with rheumatoid arthritis (mean age 61, 82% women) and not evaluated for fibromyalgia. They also looked at data on fibromyalgia symptoms from a general population sample in Germany.

A total of 22% of the RA patients in the cohort met the criteria for a fibromyalgia diagnosis under current (2016) ACR criteria, while 53% of the patients in the primary fibromyalgia group and 2.0% of the general population sample did. Symptom magnitude and severity differed only slightly between the RA and fibromyalgia-only groups, the investigators found. Those without RA had a mean PSD score of 21.9 (of a possible 31) and those with RA and who met the fibromyalgia criteria had a mean score of 20.7.

The researchers found that the disease behaved similarly whether it occurred alone or with RA. Patients with higher PSD scores experienced worse outcomes across symptom domains regardless of RA status. When controlled for PSD, pain, patient global, and health-related quality of life, scores were similar between groups. However, disability scores and painful joint counts were slightly higher in the RA group.

“Fibromyalgia can exist whether or not there’s another disorder present,” Dr. Wolfe said in an interview, “but we don’t tend to think of it that way.” Clinicians, Dr. Wolfe said, “have to be able to identify [fibromyalgia] within other disorders. It can’t be only something that you find once you’ve ruled out everything else.”

Clinicians can look to PSD scores to inform management choices, the researchers said, instead of whether the fibromyalgia is considered primary or secondary.

Dr. Wolfe said that the current bifurcated concept of the disease also creates difficulties for research into fibromyalgia treatments. For example, using RA patients as a comparator group in a clinical trial is problematic because RA patients, as this study demonstrates, also have a substantial burden of fibromyalgia. And the use of so-called healthy controls in fibromyalgia studies is also a problem, Dr. Wolfe said.

“People say they’ve tried this drug or treatment in people with fibromyalgia and on normal controls. But there’s no such thing as normal controls for fibromyalgia. Does normal mean people with zero fatigue or pain? Or do we look at what’s normal among people who have multiple sclerosis or RA? If you’re going to test things in people with fibromyalgia, you never really have normal controls because it depends on where in this whole continuum you are.”

But what this new research also shows, he said, is that while up to now “you couldn’t easily study people with fibromyalgia [in other disorders], it doesn’t matter if you have RA or another disorder in addition to fibromyalgia. You get the full spectrum or severity regardless. The underlying disease wouldn’t affect your identification of the fibromyalgia symptoms.”

Dr. Wolfe and his colleagues described as a limitation of their study the lack of comparator groups besides RA patients. Secondary fibromyalgia is also commonly reported with osteoarthritis, they noted.

The study had no outside funding and investigators reported no conflicts of interest.

SOURCE: Wolfe F et al. J Rheumatol. 2018 Jul 15. doi: 10.3899/jrheum.180083.

The symptomatology and severity of fibromyalgia is virtually identical among people with primary and secondary forms of the disorder, researchers say, and the two should therefore be considered the same.

Currently, patients classified as having primary fibromyalgia have a defined set of pain, fatigue, cognitive, and psychological symptoms in the absence of a clinically important inflammatory disorder, while secondary fibromyalgia occurs in the context of a disease such as rheumatoid arthritis.

In research published online in the Journal of Rheumatology, investigators led by Frederick Wolfe, MD, of the National Data Bank for Rheumatic Diseases and the University of Kansas in Wichita, sought to understand whether patients with primary and secondary diagnoses “had the same level of outcomes, symptoms, and characteristics” at different points across the polysymptomatic distress (PSD) scale, a measure to assess severity in fibromyalgia.

The PSD is calculated by combining two measurements used in fibromyalgia: the widespread pain index (WPI), which counts the number of painful regions in the body, and the somatic symptom scale (SSS), which measures fatigue, sleep, emotional and cognitive problems, and the extent of symptom reporting. Higher PSD scores correlate to worse outcomes, including for disability and health-related quality of life.

Dr. Wolfe and his colleagues compared records from 1,525 patients (mean age 57, 95% women) in the National Data Bank who were diagnosed with fibromyalgia only, with those from 12,037 people with rheumatoid arthritis (mean age 61, 82% women) and not evaluated for fibromyalgia. They also looked at data on fibromyalgia symptoms from a general population sample in Germany.

A total of 22% of the RA patients in the cohort met the criteria for a fibromyalgia diagnosis under current (2016) ACR criteria, while 53% of the patients in the primary fibromyalgia group and 2.0% of the general population sample did. Symptom magnitude and severity differed only slightly between the RA and fibromyalgia-only groups, the investigators found. Those without RA had a mean PSD score of 21.9 (of a possible 31) and those with RA and who met the fibromyalgia criteria had a mean score of 20.7.

The researchers found that the disease behaved similarly whether it occurred alone or with RA. Patients with higher PSD scores experienced worse outcomes across symptom domains regardless of RA status. When controlled for PSD, pain, patient global, and health-related quality of life, scores were similar between groups. However, disability scores and painful joint counts were slightly higher in the RA group.

“Fibromyalgia can exist whether or not there’s another disorder present,” Dr. Wolfe said in an interview, “but we don’t tend to think of it that way.” Clinicians, Dr. Wolfe said, “have to be able to identify [fibromyalgia] within other disorders. It can’t be only something that you find once you’ve ruled out everything else.”

Clinicians can look to PSD scores to inform management choices, the researchers said, instead of whether the fibromyalgia is considered primary or secondary.

Dr. Wolfe said that the current bifurcated concept of the disease also creates difficulties for research into fibromyalgia treatments. For example, using RA patients as a comparator group in a clinical trial is problematic because RA patients, as this study demonstrates, also have a substantial burden of fibromyalgia. And the use of so-called healthy controls in fibromyalgia studies is also a problem, Dr. Wolfe said.

“People say they’ve tried this drug or treatment in people with fibromyalgia and on normal controls. But there’s no such thing as normal controls for fibromyalgia. Does normal mean people with zero fatigue or pain? Or do we look at what’s normal among people who have multiple sclerosis or RA? If you’re going to test things in people with fibromyalgia, you never really have normal controls because it depends on where in this whole continuum you are.”

But what this new research also shows, he said, is that while up to now “you couldn’t easily study people with fibromyalgia [in other disorders], it doesn’t matter if you have RA or another disorder in addition to fibromyalgia. You get the full spectrum or severity regardless. The underlying disease wouldn’t affect your identification of the fibromyalgia symptoms.”

Dr. Wolfe and his colleagues described as a limitation of their study the lack of comparator groups besides RA patients. Secondary fibromyalgia is also commonly reported with osteoarthritis, they noted.

The study had no outside funding and investigators reported no conflicts of interest.

SOURCE: Wolfe F et al. J Rheumatol. 2018 Jul 15. doi: 10.3899/jrheum.180083.

Diabetes mellitus (DM) is a metabolic disorder affecting about 5% to 13% of the population in the US.¹ Since 1552, the earliest record of a person with DM, many treatment advances have been made.²Sodium-glucose cotransporter 2 (SGLT2) inhibitors are one of the newest antidiabetic pharmaceuticals on the market. The SGLT2 inhibitor drugs include canagliflozin, dapagliflozin, empagliflozin, ipragliflozin, and tofogliflozin; however, only canagliflozin, dapagliflozin, and empagliflozin have been approved by the US Food and Drug Administration (FDA). These pharmaceuticals promote glycosuria via the kidneys and enhance sugar excretion from the body. Along with lifestyle changes and self-care measures, such as healthful eating and increased physical activity, SGLT2 inhibitor pharmaceuticals provide antidiabetic efficacy by facilitating normoglycemia and minimizing vascular pathology.

Although SGLT2 inhibitor pharmaceuticals are newly introduced into the market, their discovery dates to 1835.³ Phlorizin, a nonselective SGLT inhibitor, was first isolated by French chemists from the bark of an apple tree.⁴ Phlorizin inhibits SGLT1 mostly in small intestinal cells, and SGLT2 similarly affects the kidney.⁴ Renal SGLT2 is the primary therapeutic target. Canagliflozin was the first pharmaceutical SGLT2 inhibitor approved by the FDA in 2013. Dapagliflozin’s FDA approval followed in 2013 and empagliflozin in 2014.⁵

Mechanism Of Action

In healthy individuals, tubular glucose is absorbed, resulting in no urinary glucose excretion. Sodium-glucose cotransporters 1 and 2 contribute to the renal absorption of glucose. A SGLT2 is responsible for 90% of the glucose reuptake in the segment 1 of the proximal tubule, while SGLT 1 is accountable for the remaining 10%.³ Unlike other antidiabetic medications, which act by increasing insulin secretion or improving insulin sensitivity for the receptors, SGLT2 inhibitor drugs prevent the reuptake of glucose into the bloodstream. This selective action spares the inhibition of SGLT1 present in other tissues, avoiding gastrointestinal effects.⁶

Benefits

The SGLT2 inhibitor action is focused on renal excretion of glucose and is independent of insulin action. 

Hemoglobin A_1c Levels

Canagliflozin, dapagliflozin, and empagliflozin reduce hemoglobin A_1c (HbA_1c) levels.⁵ Inagaki and colleagues found significant reductions in HbA_1c and weight gain with > 100 mg canagliflozin compared with that of placebo when used for 12 weeks.⁷ In a study where 2.5-mg, 5-mg, and 10-mg dapagliflozin was compared with placebo, the mean HbA_1c change from the baseline was -0.23% with placebo; -0.58% at 2.5 mg; -0.77% at 5 mg; and -0.89% at 10 mg.⁸ Empagliflozin was more effective in reducing HbA_1c levels than was sitagliptin.⁹ When patients were treated with 10-mg empagliflozin, 25-mg empagliflozin, and sitagliptin, HbA_1c levels dropped -1.44%, -1.43%, and -1.04%, respectively.⁹

Cholesterol

Sodium-glucose cotransporter 2 inhibitors have the beneficial effect of reducing vascular disease risk factors.^10,11 A study by Hayashi and colleagues found that dapagliflozin decreases harmful atherogenic small, low-density lipoprotein-cholesterol (LDL-C), increases less atherogenic large, buoyant LDL-C, and increases high-density, lipoprotein-2 cholesterol (HDL-2C).¹⁰ Empagliflozin, however, can cause a small dose-dependent increase in HDL-C and LDL-C.¹¹ Although there is an increase in serum LDL-C concentrations, empagliflozin can induce a decrease in intestinal absorption of cholesterol, thus promoting fecal excretion of LDL-C and macrophage-derived cholesterol.¹¹

Weight Loss

A study by Weber and colleagues found that the SGLT2 inhibitor dapagloflozin lead to a reduction in body weight from -1.0 kg to -0.3 kg compared with placebo.¹² Cefalu and colleagues found that daily prescribing of 100 mg and/or 300 mg of canagliflozin evidenced dose-dependent loss of weight.¹³ Neeland and colleagues found that empagliflozin utilization resulted in less adiposity indices in 3,300 subjects.¹⁴

Albuminuria

Sodium-glucose cotransporter 2 inhibitors have a reno-protective role in patients with type 2 DM (T2DM). In those receiving renin-angiotensin blockers with T2DM and hypertension, dapagliflozin decreased their albuminuria.¹⁵ Canagliflozin has a similar potential.¹⁶ Empagliflozin reduced the urine albumin-creatinine ratio in patients with macro- or micro-albuminuria, supporting a direct renal effect by SGLT2 inhibitors.¹⁷

Systolic Blood Pressure

Sodium-glucose cotransporter 2 inhibitors can have beneficial effects on physiologic vascular outcomes. In patients with T2DM and hypertension, dapagliflozin reduced mean systolic blood pressure (SBP) compared with placebo: -7.3 mm Hg vs -10.4 mm Hg, respectively.¹² Prescribing canagliflozin treatment at 100 mg or 300 mg reduced SBP (-4.3 mm Hg and -5.0 mm Hg, respectively, vs placebo at -0.3 mm Hg).¹⁸ Subjects taking empagliflozin 10 mg or 25 mg exhibited an adjusted mean BP change from baseline of -4.60 mm Hg and -5.47mm Hg, respectively, whereas placebo induced a -0.67 mm Hg decline.¹⁹

Risks

Nausea, fatigue, polyuria, polydipsia, and xerostomia are common SGLT2 AEs. Use of SGLT2 inhibitors can induce certain other more serious AEs as well.

Increased Risk for Amputations

The Canagliflozin Cardiovascular Assessment Study (CANVAS) and the Canagliflozin Cardiovascular Assessment Study-Renal (CANVAS-R) documented that canagliflozin doubled the incidence of leg and foot amputations in research participants compared with placebo (6.3 vs 3.4 per 1,000 patient-years).¹⁶ Therefore, canagliflozin should be prescribed with caution in persons with a prior history of foot ulceration, neuropathy, and/or vascular diseases.²⁰

Acute Renal Injury

The mechanism of kidney damage by SGLT2 inhibitor drugs is not completely understood. About 100 patients experienced renal failure after the intake of SGLT2 inhibitor drugs.²¹ Among them, more than half reported symptom onset within a month of starting the medication, and their symptoms improved after discontinuing the SGLT2 medication. As a result, the FDA issued a warning to monitor renal function before initiating and during such pharmacotherapy.²¹

Ketoacidosis

Sodium-glucose cotransporter 2 inhibitors might lead to elevated ketone body levels²² and euglycemic ketoacidosis;²³ however, this risk reportedly is negligible.²⁴ Use of SGLT2 inhibitors is not recommended for patients evidencing the presence of precipitating factors like acute gastroenteritis or insulin pump failure.²⁵

Genitourinary Infections

About 10% to 15% of women taking SGLT2 inhibitor medications developed urinary tract infections and vulvovaginitis.²⁶ This could be because of a glycosuria effect caused by SGLT2 inhibitors.²⁷

Hypotension

Sodium-glucose cotransporter 2 inhibitors cause contraction of intravascular volume. Therefore, patients taking SGLT2 inhibitors are at risk for hypotension, leading to dizziness and potentially dangerous falls. Patients already taking volume-depleting medications, such as diuretics, should be advised to use this group of medications with caution and report these AEs.²⁸

Bone Fractures

A clinical trial revealed that SGLT2 inhibitors, such as canagliflozin, decrease bone mineral density possibly leading to bone fractures.²⁹ Bone fractures occurred in about 1.5% of cases of patients taking 100 mg and 300 mg of canagliflozin compared with a 1.1% fracture rate among the placebo group.²⁹

Conclusion

Since the FDA approval of SGLT2 inhibitor medications, their usage has increased. The American Diabetes Association first recommends nonpharmacologic approaches, such as diet modification, exercise, and weight loss for patients diagnosed with DM, followed by a medicinal intervention with metformin if required. Sodium-glucose cotransporter 2 inhibitors are suggested as an additional medication in dual or triple pharmacotherapies when metformin alone fails to achieve normoglycemia.

Prior to starting a patient on SGLT2 inhibitor medication, clinicians should monitor hydration adequacy, check bone density, review the patient’s cardiac profile, and assess hepatic and renal function. Prescribing SGLT2 inhibitors should be restricted if the patient has a history of type 1 DM, ketosisprone T2DM, and in those with a glomerular filtration rate of < 60 mL/min. Considering the preexisting medical conditions of the patient and monitoring the blood glucose levels, renal function, and volume status at every visit should minimize risks and enhance the benefits of prescribing this new medication class.

Diabetes mellitus (DM) is a metabolic disorder affecting about 5% to 13% of the population in the US.¹ Since 1552, the earliest record of a person with DM, many treatment advances have been made.²Sodium-glucose cotransporter 2 (SGLT2) inhibitors are one of the newest antidiabetic pharmaceuticals on the market. The SGLT2 inhibitor drugs include canagliflozin, dapagliflozin, empagliflozin, ipragliflozin, and tofogliflozin; however, only canagliflozin, dapagliflozin, and empagliflozin have been approved by the US Food and Drug Administration (FDA). These pharmaceuticals promote glycosuria via the kidneys and enhance sugar excretion from the body. Along with lifestyle changes and self-care measures, such as healthful eating and increased physical activity, SGLT2 inhibitor pharmaceuticals provide antidiabetic efficacy by facilitating normoglycemia and minimizing vascular pathology.

Although SGLT2 inhibitor pharmaceuticals are newly introduced into the market, their discovery dates to 1835.³ Phlorizin, a nonselective SGLT inhibitor, was first isolated by French chemists from the bark of an apple tree.⁴ Phlorizin inhibits SGLT1 mostly in small intestinal cells, and SGLT2 similarly affects the kidney.⁴ Renal SGLT2 is the primary therapeutic target. Canagliflozin was the first pharmaceutical SGLT2 inhibitor approved by the FDA in 2013. Dapagliflozin’s FDA approval followed in 2013 and empagliflozin in 2014.⁵

Mechanism Of Action

In healthy individuals, tubular glucose is absorbed, resulting in no urinary glucose excretion. Sodium-glucose cotransporters 1 and 2 contribute to the renal absorption of glucose. A SGLT2 is responsible for 90% of the glucose reuptake in the segment 1 of the proximal tubule, while SGLT 1 is accountable for the remaining 10%.³ Unlike other antidiabetic medications, which act by increasing insulin secretion or improving insulin sensitivity for the receptors, SGLT2 inhibitor drugs prevent the reuptake of glucose into the bloodstream. This selective action spares the inhibition of SGLT1 present in other tissues, avoiding gastrointestinal effects.⁶

Benefits

The SGLT2 inhibitor action is focused on renal excretion of glucose and is independent of insulin action. 

Hemoglobin A_1c Levels

Canagliflozin, dapagliflozin, and empagliflozin reduce hemoglobin A_1c (HbA_1c) levels.⁵ Inagaki and colleagues found significant reductions in HbA_1c and weight gain with > 100 mg canagliflozin compared with that of placebo when used for 12 weeks.⁷ In a study where 2.5-mg, 5-mg, and 10-mg dapagliflozin was compared with placebo, the mean HbA_1c change from the baseline was -0.23% with placebo; -0.58% at 2.5 mg; -0.77% at 5 mg; and -0.89% at 10 mg.⁸ Empagliflozin was more effective in reducing HbA_1c levels than was sitagliptin.⁹ When patients were treated with 10-mg empagliflozin, 25-mg empagliflozin, and sitagliptin, HbA_1c levels dropped -1.44%, -1.43%, and -1.04%, respectively.⁹

Cholesterol

Sodium-glucose cotransporter 2 inhibitors have the beneficial effect of reducing vascular disease risk factors.^10,11 A study by Hayashi and colleagues found that dapagliflozin decreases harmful atherogenic small, low-density lipoprotein-cholesterol (LDL-C), increases less atherogenic large, buoyant LDL-C, and increases high-density, lipoprotein-2 cholesterol (HDL-2C).¹⁰ Empagliflozin, however, can cause a small dose-dependent increase in HDL-C and LDL-C.¹¹ Although there is an increase in serum LDL-C concentrations, empagliflozin can induce a decrease in intestinal absorption of cholesterol, thus promoting fecal excretion of LDL-C and macrophage-derived cholesterol.¹¹

Weight Loss

A study by Weber and colleagues found that the SGLT2 inhibitor dapagloflozin lead to a reduction in body weight from -1.0 kg to -0.3 kg compared with placebo.¹² Cefalu and colleagues found that daily prescribing of 100 mg and/or 300 mg of canagliflozin evidenced dose-dependent loss of weight.¹³ Neeland and colleagues found that empagliflozin utilization resulted in less adiposity indices in 3,300 subjects.¹⁴

Albuminuria

Sodium-glucose cotransporter 2 inhibitors have a reno-protective role in patients with type 2 DM (T2DM). In those receiving renin-angiotensin blockers with T2DM and hypertension, dapagliflozin decreased their albuminuria.¹⁵ Canagliflozin has a similar potential.¹⁶ Empagliflozin reduced the urine albumin-creatinine ratio in patients with macro- or micro-albuminuria, supporting a direct renal effect by SGLT2 inhibitors.¹⁷

Systolic Blood Pressure

Sodium-glucose cotransporter 2 inhibitors can have beneficial effects on physiologic vascular outcomes. In patients with T2DM and hypertension, dapagliflozin reduced mean systolic blood pressure (SBP) compared with placebo: -7.3 mm Hg vs -10.4 mm Hg, respectively.¹² Prescribing canagliflozin treatment at 100 mg or 300 mg reduced SBP (-4.3 mm Hg and -5.0 mm Hg, respectively, vs placebo at -0.3 mm Hg).¹⁸ Subjects taking empagliflozin 10 mg or 25 mg exhibited an adjusted mean BP change from baseline of -4.60 mm Hg and -5.47mm Hg, respectively, whereas placebo induced a -0.67 mm Hg decline.¹⁹

Risks

Nausea, fatigue, polyuria, polydipsia, and xerostomia are common SGLT2 AEs. Use of SGLT2 inhibitors can induce certain other more serious AEs as well.

Increased Risk for Amputations

The Canagliflozin Cardiovascular Assessment Study (CANVAS) and the Canagliflozin Cardiovascular Assessment Study-Renal (CANVAS-R) documented that canagliflozin doubled the incidence of leg and foot amputations in research participants compared with placebo (6.3 vs 3.4 per 1,000 patient-years).¹⁶ Therefore, canagliflozin should be prescribed with caution in persons with a prior history of foot ulceration, neuropathy, and/or vascular diseases.²⁰

Acute Renal Injury

The mechanism of kidney damage by SGLT2 inhibitor drugs is not completely understood. About 100 patients experienced renal failure after the intake of SGLT2 inhibitor drugs.²¹ Among them, more than half reported symptom onset within a month of starting the medication, and their symptoms improved after discontinuing the SGLT2 medication. As a result, the FDA issued a warning to monitor renal function before initiating and during such pharmacotherapy.²¹

Ketoacidosis

Sodium-glucose cotransporter 2 inhibitors might lead to elevated ketone body levels²² and euglycemic ketoacidosis;²³ however, this risk reportedly is negligible.²⁴ Use of SGLT2 inhibitors is not recommended for patients evidencing the presence of precipitating factors like acute gastroenteritis or insulin pump failure.²⁵

Genitourinary Infections

About 10% to 15% of women taking SGLT2 inhibitor medications developed urinary tract infections and vulvovaginitis.²⁶ This could be because of a glycosuria effect caused by SGLT2 inhibitors.²⁷

Hypotension

Sodium-glucose cotransporter 2 inhibitors cause contraction of intravascular volume. Therefore, patients taking SGLT2 inhibitors are at risk for hypotension, leading to dizziness and potentially dangerous falls. Patients already taking volume-depleting medications, such as diuretics, should be advised to use this group of medications with caution and report these AEs.²⁸

Bone Fractures

A clinical trial revealed that SGLT2 inhibitors, such as canagliflozin, decrease bone mineral density possibly leading to bone fractures.²⁹ Bone fractures occurred in about 1.5% of cases of patients taking 100 mg and 300 mg of canagliflozin compared with a 1.1% fracture rate among the placebo group.²⁹

Conclusion

Since the FDA approval of SGLT2 inhibitor medications, their usage has increased. The American Diabetes Association first recommends nonpharmacologic approaches, such as diet modification, exercise, and weight loss for patients diagnosed with DM, followed by a medicinal intervention with metformin if required. Sodium-glucose cotransporter 2 inhibitors are suggested as an additional medication in dual or triple pharmacotherapies when metformin alone fails to achieve normoglycemia.

Prior to starting a patient on SGLT2 inhibitor medication, clinicians should monitor hydration adequacy, check bone density, review the patient’s cardiac profile, and assess hepatic and renal function. Prescribing SGLT2 inhibitors should be restricted if the patient has a history of type 1 DM, ketosisprone T2DM, and in those with a glomerular filtration rate of < 60 mL/min. Considering the preexisting medical conditions of the patient and monitoring the blood glucose levels, renal function, and volume status at every visit should minimize risks and enhance the benefits of prescribing this new medication class.

Diabetes mellitus (DM) is a metabolic disorder affecting about 5% to 13% of the population in the US.¹ Since 1552, the earliest record of a person with DM, many treatment advances have been made.²Sodium-glucose cotransporter 2 (SGLT2) inhibitors are one of the newest antidiabetic pharmaceuticals on the market. The SGLT2 inhibitor drugs include canagliflozin, dapagliflozin, empagliflozin, ipragliflozin, and tofogliflozin; however, only canagliflozin, dapagliflozin, and empagliflozin have been approved by the US Food and Drug Administration (FDA). These pharmaceuticals promote glycosuria via the kidneys and enhance sugar excretion from the body. Along with lifestyle changes and self-care measures, such as healthful eating and increased physical activity, SGLT2 inhibitor pharmaceuticals provide antidiabetic efficacy by facilitating normoglycemia and minimizing vascular pathology.

Although SGLT2 inhibitor pharmaceuticals are newly introduced into the market, their discovery dates to 1835.³ Phlorizin, a nonselective SGLT inhibitor, was first isolated by French chemists from the bark of an apple tree.⁴ Phlorizin inhibits SGLT1 mostly in small intestinal cells, and SGLT2 similarly affects the kidney.⁴ Renal SGLT2 is the primary therapeutic target. Canagliflozin was the first pharmaceutical SGLT2 inhibitor approved by the FDA in 2013. Dapagliflozin’s FDA approval followed in 2013 and empagliflozin in 2014.⁵

Mechanism Of Action

In healthy individuals, tubular glucose is absorbed, resulting in no urinary glucose excretion. Sodium-glucose cotransporters 1 and 2 contribute to the renal absorption of glucose. A SGLT2 is responsible for 90% of the glucose reuptake in the segment 1 of the proximal tubule, while SGLT 1 is accountable for the remaining 10%.³ Unlike other antidiabetic medications, which act by increasing insulin secretion or improving insulin sensitivity for the receptors, SGLT2 inhibitor drugs prevent the reuptake of glucose into the bloodstream. This selective action spares the inhibition of SGLT1 present in other tissues, avoiding gastrointestinal effects.⁶

Benefits

The SGLT2 inhibitor action is focused on renal excretion of glucose and is independent of insulin action. 

Hemoglobin A_1c Levels

Canagliflozin, dapagliflozin, and empagliflozin reduce hemoglobin A_1c (HbA_1c) levels.⁵ Inagaki and colleagues found significant reductions in HbA_1c and weight gain with > 100 mg canagliflozin compared with that of placebo when used for 12 weeks.⁷ In a study where 2.5-mg, 5-mg, and 10-mg dapagliflozin was compared with placebo, the mean HbA_1c change from the baseline was -0.23% with placebo; -0.58% at 2.5 mg; -0.77% at 5 mg; and -0.89% at 10 mg.⁸ Empagliflozin was more effective in reducing HbA_1c levels than was sitagliptin.⁹ When patients were treated with 10-mg empagliflozin, 25-mg empagliflozin, and sitagliptin, HbA_1c levels dropped -1.44%, -1.43%, and -1.04%, respectively.⁹

Cholesterol

Sodium-glucose cotransporter 2 inhibitors have the beneficial effect of reducing vascular disease risk factors.^10,11 A study by Hayashi and colleagues found that dapagliflozin decreases harmful atherogenic small, low-density lipoprotein-cholesterol (LDL-C), increases less atherogenic large, buoyant LDL-C, and increases high-density, lipoprotein-2 cholesterol (HDL-2C).¹⁰ Empagliflozin, however, can cause a small dose-dependent increase in HDL-C and LDL-C.¹¹ Although there is an increase in serum LDL-C concentrations, empagliflozin can induce a decrease in intestinal absorption of cholesterol, thus promoting fecal excretion of LDL-C and macrophage-derived cholesterol.¹¹

Weight Loss

A study by Weber and colleagues found that the SGLT2 inhibitor dapagloflozin lead to a reduction in body weight from -1.0 kg to -0.3 kg compared with placebo.¹² Cefalu and colleagues found that daily prescribing of 100 mg and/or 300 mg of canagliflozin evidenced dose-dependent loss of weight.¹³ Neeland and colleagues found that empagliflozin utilization resulted in less adiposity indices in 3,300 subjects.¹⁴

Albuminuria

Sodium-glucose cotransporter 2 inhibitors have a reno-protective role in patients with type 2 DM (T2DM). In those receiving renin-angiotensin blockers with T2DM and hypertension, dapagliflozin decreased their albuminuria.¹⁵ Canagliflozin has a similar potential.¹⁶ Empagliflozin reduced the urine albumin-creatinine ratio in patients with macro- or micro-albuminuria, supporting a direct renal effect by SGLT2 inhibitors.¹⁷

Systolic Blood Pressure

Sodium-glucose cotransporter 2 inhibitors can have beneficial effects on physiologic vascular outcomes. In patients with T2DM and hypertension, dapagliflozin reduced mean systolic blood pressure (SBP) compared with placebo: -7.3 mm Hg vs -10.4 mm Hg, respectively.¹² Prescribing canagliflozin treatment at 100 mg or 300 mg reduced SBP (-4.3 mm Hg and -5.0 mm Hg, respectively, vs placebo at -0.3 mm Hg).¹⁸ Subjects taking empagliflozin 10 mg or 25 mg exhibited an adjusted mean BP change from baseline of -4.60 mm Hg and -5.47mm Hg, respectively, whereas placebo induced a -0.67 mm Hg decline.¹⁹

Risks

Nausea, fatigue, polyuria, polydipsia, and xerostomia are common SGLT2 AEs. Use of SGLT2 inhibitors can induce certain other more serious AEs as well.

Increased Risk for Amputations

The Canagliflozin Cardiovascular Assessment Study (CANVAS) and the Canagliflozin Cardiovascular Assessment Study-Renal (CANVAS-R) documented that canagliflozin doubled the incidence of leg and foot amputations in research participants compared with placebo (6.3 vs 3.4 per 1,000 patient-years).¹⁶ Therefore, canagliflozin should be prescribed with caution in persons with a prior history of foot ulceration, neuropathy, and/or vascular diseases.²⁰

Acute Renal Injury

The mechanism of kidney damage by SGLT2 inhibitor drugs is not completely understood. About 100 patients experienced renal failure after the intake of SGLT2 inhibitor drugs.²¹ Among them, more than half reported symptom onset within a month of starting the medication, and their symptoms improved after discontinuing the SGLT2 medication. As a result, the FDA issued a warning to monitor renal function before initiating and during such pharmacotherapy.²¹

Ketoacidosis

Sodium-glucose cotransporter 2 inhibitors might lead to elevated ketone body levels²² and euglycemic ketoacidosis;²³ however, this risk reportedly is negligible.²⁴ Use of SGLT2 inhibitors is not recommended for patients evidencing the presence of precipitating factors like acute gastroenteritis or insulin pump failure.²⁵

Genitourinary Infections

About 10% to 15% of women taking SGLT2 inhibitor medications developed urinary tract infections and vulvovaginitis.²⁶ This could be because of a glycosuria effect caused by SGLT2 inhibitors.²⁷

Hypotension

Sodium-glucose cotransporter 2 inhibitors cause contraction of intravascular volume. Therefore, patients taking SGLT2 inhibitors are at risk for hypotension, leading to dizziness and potentially dangerous falls. Patients already taking volume-depleting medications, such as diuretics, should be advised to use this group of medications with caution and report these AEs.²⁸

Bone Fractures

A clinical trial revealed that SGLT2 inhibitors, such as canagliflozin, decrease bone mineral density possibly leading to bone fractures.²⁹ Bone fractures occurred in about 1.5% of cases of patients taking 100 mg and 300 mg of canagliflozin compared with a 1.1% fracture rate among the placebo group.²⁹

Conclusion

Since the FDA approval of SGLT2 inhibitor medications, their usage has increased. The American Diabetes Association first recommends nonpharmacologic approaches, such as diet modification, exercise, and weight loss for patients diagnosed with DM, followed by a medicinal intervention with metformin if required. Sodium-glucose cotransporter 2 inhibitors are suggested as an additional medication in dual or triple pharmacotherapies when metformin alone fails to achieve normoglycemia.

Prior to starting a patient on SGLT2 inhibitor medication, clinicians should monitor hydration adequacy, check bone density, review the patient’s cardiac profile, and assess hepatic and renal function. Prescribing SGLT2 inhibitors should be restricted if the patient has a history of type 1 DM, ketosisprone T2DM, and in those with a glomerular filtration rate of < 60 mL/min. Considering the preexisting medical conditions of the patient and monitoring the blood glucose levels, renal function, and volume status at every visit should minimize risks and enhance the benefits of prescribing this new medication class.