Guidelines

Leading endocrinology societies have copublished an algorithm offering updated, specific clinical guidance on lifestyle therapy, management of hypertension and dyslipidemia, and glucose control in patients with type 2 diabetes.

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This update from the American Association of Clinical Endocrinologists and the American College of Endocrinology, published in Endocrine Practice, also highlights obesity and prediabetes as underlying risk factors for development of diabetes.

The algorithm, based on new and “comprehensive clinical data” on type 2 diabetes management, is designed as a supplement 2015 AACE/ACE clinical practice guidelines, according to Alan J. Garber, MD, PhD, chair of the Diabetes Management Algorithm Task Force.

“It’s intended to provide clinicians with a practical guide that prompts them to look for factors or influences in the patient’s lifestyle or health that may be a factor in identifying the best treatment approach or medication,” he said in a statement.

Lifestyle medication is critical for all patients with diabetes, according to Dr. Garber and the algorithm coauthors, who recommended a “primarily plant-based meal plan” that limits intake of saturated fatty acids and avoids trans fats. They said overweight patients should restrict caloric intake with a goal of reducing body weight by up to 10%.

Physical activity should include at least 150 minutes per week of activities such as brisk walking or weight training, they said, adding that patients should be advised to sleep 7 hours per night, on average.

Weight loss medications might be needed along with lifestyle modification for patients with body mass index (BMI) over 27 kg/m² with complications, and for all patients with BMI over 30 regardless of whether they have complications, according to the AACE/ACE committee members who drafted the report.

Bariatric surgery might be considered in patients with BMI over 35 and comorbidities, particularly if patients fail to achieve weight loss goals using other means, they added.

The primary goal of prediabetes management is weight loss, wrote the authors. While there are no Food and Drug Administration–approved agents for prediabetes management, they said, antihyperglycemic agents such as metformin and acarbose have been shown to reduce risk of diabetes by 25%-30% in patients with prediabetes.

While pressure control needs to be individualized, but a goal of less than 130/80 mm Hg is warranted for most patients with diabetes, according to the authors, who note that most patients will require medication to reach their goal.

“Because angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers can slow progression of nephropathy and retinopathy, they are preferred for patients with type 2 diabetes,” said Dr. Garber and his coauthors in the executive summary accompanying the algorithm.

Early and intensive management of dyslipidemia is important to reduce the significant risk of atherosclerotic cardiovascular disease in patients with diabetes, according to the authors, who say diabetes patients should be classified as high risk, very high risk, or extreme risk. They recommended LDL cholesterol targets of less than 100 mg/dL for high-risk patients, less than 70 mg/dL for very-high-risk patients, and less than 55 mg/dL for the extreme-risk group.

Statins should be considered first-line treatment for lowering cholesterol, unless contraindicated, with other lipid-modifying agents added as needed to reach lipid targets.

Inhibitors of proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9) address a “large unmet need” for more aggressive lipid lowering in patients with clinical atherosclerotic disease and diabetes, the authors noted.

Added to maximal statin therapy, PCSK9 inhibitors reduce LDL cholesterol by about 50% while also raising HDL cholesterol and having positive effects on other lipids, according to the authors.

Pharmacotherapy for type 2 diabetes requires a “nuanced approach” that takes into account factors such as age, comorbidities, and risk of hypoglycemia, the authors wrote, noting that the AACE supports a hemoglobin A1c target of 6.5% or less for most patients.

The algorithm for glycemic control lists glucose-lowering agents in order of recommended usage. For example, in patients with an entry HbA_1c less than 7.5%, the strongest recommendations for were monotherapy with metformin, followed by GLP1 receptor agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors.

If insulin becomes necessary, the recommended approach is to add a single daily dose of basal insulin, and if a basal insulin regimen fails to control glucose, it may help to add a GLP1 receptor agonist or dipeptidyl peptidase 4 (DPP4) inhibitor, according to the algorithm.

Avoiding hypoglycemia is important, and one possible “safety measure” to prevent that is using a continuous glucose monitoring device that provides real-time glucose data. “Significant advances have been made in accuracy and availability of CGM devices,” the authors wrote.

Current expert consensus is that clinical CGM devices should be considered if patients have not achieved their glycemic target after 3 months or if they need a treatment that puts them at risk for hypoglycemia, according to Dr. Garber and his colleagues.

Dr. Garber reported that he had no financial relationships relevant to the consensus statement and algorithm. Coauthors of the report provided disclosures related to Novo Nordisk, Eli Lilly, Janssen Pharmaceuticals, Abbott, Sanofi-Aventis, and other pharmaceutical companies.
 

[email protected]

SOURCE: Garber AJ et al. Endocr Pract. 2019 Jan;25(1):91-120.

Leading endocrinology societies have copublished an algorithm offering updated, specific clinical guidance on lifestyle therapy, management of hypertension and dyslipidemia, and glucose control in patients with type 2 diabetes.

iStock/Getty Images

This update from the American Association of Clinical Endocrinologists and the American College of Endocrinology, published in Endocrine Practice, also highlights obesity and prediabetes as underlying risk factors for development of diabetes.

The algorithm, based on new and “comprehensive clinical data” on type 2 diabetes management, is designed as a supplement 2015 AACE/ACE clinical practice guidelines, according to Alan J. Garber, MD, PhD, chair of the Diabetes Management Algorithm Task Force.

“It’s intended to provide clinicians with a practical guide that prompts them to look for factors or influences in the patient’s lifestyle or health that may be a factor in identifying the best treatment approach or medication,” he said in a statement.

Lifestyle medication is critical for all patients with diabetes, according to Dr. Garber and the algorithm coauthors, who recommended a “primarily plant-based meal plan” that limits intake of saturated fatty acids and avoids trans fats. They said overweight patients should restrict caloric intake with a goal of reducing body weight by up to 10%.

Physical activity should include at least 150 minutes per week of activities such as brisk walking or weight training, they said, adding that patients should be advised to sleep 7 hours per night, on average.

Weight loss medications might be needed along with lifestyle modification for patients with body mass index (BMI) over 27 kg/m² with complications, and for all patients with BMI over 30 regardless of whether they have complications, according to the AACE/ACE committee members who drafted the report.

Bariatric surgery might be considered in patients with BMI over 35 and comorbidities, particularly if patients fail to achieve weight loss goals using other means, they added.

The primary goal of prediabetes management is weight loss, wrote the authors. While there are no Food and Drug Administration–approved agents for prediabetes management, they said, antihyperglycemic agents such as metformin and acarbose have been shown to reduce risk of diabetes by 25%-30% in patients with prediabetes.

While pressure control needs to be individualized, but a goal of less than 130/80 mm Hg is warranted for most patients with diabetes, according to the authors, who note that most patients will require medication to reach their goal.

“Because angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers can slow progression of nephropathy and retinopathy, they are preferred for patients with type 2 diabetes,” said Dr. Garber and his coauthors in the executive summary accompanying the algorithm.

Early and intensive management of dyslipidemia is important to reduce the significant risk of atherosclerotic cardiovascular disease in patients with diabetes, according to the authors, who say diabetes patients should be classified as high risk, very high risk, or extreme risk. They recommended LDL cholesterol targets of less than 100 mg/dL for high-risk patients, less than 70 mg/dL for very-high-risk patients, and less than 55 mg/dL for the extreme-risk group.

Statins should be considered first-line treatment for lowering cholesterol, unless contraindicated, with other lipid-modifying agents added as needed to reach lipid targets.

Inhibitors of proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9) address a “large unmet need” for more aggressive lipid lowering in patients with clinical atherosclerotic disease and diabetes, the authors noted.

Added to maximal statin therapy, PCSK9 inhibitors reduce LDL cholesterol by about 50% while also raising HDL cholesterol and having positive effects on other lipids, according to the authors.

Pharmacotherapy for type 2 diabetes requires a “nuanced approach” that takes into account factors such as age, comorbidities, and risk of hypoglycemia, the authors wrote, noting that the AACE supports a hemoglobin A1c target of 6.5% or less for most patients.

The algorithm for glycemic control lists glucose-lowering agents in order of recommended usage. For example, in patients with an entry HbA_1c less than 7.5%, the strongest recommendations for were monotherapy with metformin, followed by GLP1 receptor agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors.

If insulin becomes necessary, the recommended approach is to add a single daily dose of basal insulin, and if a basal insulin regimen fails to control glucose, it may help to add a GLP1 receptor agonist or dipeptidyl peptidase 4 (DPP4) inhibitor, according to the algorithm.

Avoiding hypoglycemia is important, and one possible “safety measure” to prevent that is using a continuous glucose monitoring device that provides real-time glucose data. “Significant advances have been made in accuracy and availability of CGM devices,” the authors wrote.

Current expert consensus is that clinical CGM devices should be considered if patients have not achieved their glycemic target after 3 months or if they need a treatment that puts them at risk for hypoglycemia, according to Dr. Garber and his colleagues.

Dr. Garber reported that he had no financial relationships relevant to the consensus statement and algorithm. Coauthors of the report provided disclosures related to Novo Nordisk, Eli Lilly, Janssen Pharmaceuticals, Abbott, Sanofi-Aventis, and other pharmaceutical companies.
 

[email protected]

SOURCE: Garber AJ et al. Endocr Pract. 2019 Jan;25(1):91-120.

Leading endocrinology societies have copublished an algorithm offering updated, specific clinical guidance on lifestyle therapy, management of hypertension and dyslipidemia, and glucose control in patients with type 2 diabetes.

iStock/Getty Images

This update from the American Association of Clinical Endocrinologists and the American College of Endocrinology, published in Endocrine Practice, also highlights obesity and prediabetes as underlying risk factors for development of diabetes.

The algorithm, based on new and “comprehensive clinical data” on type 2 diabetes management, is designed as a supplement 2015 AACE/ACE clinical practice guidelines, according to Alan J. Garber, MD, PhD, chair of the Diabetes Management Algorithm Task Force.

“It’s intended to provide clinicians with a practical guide that prompts them to look for factors or influences in the patient’s lifestyle or health that may be a factor in identifying the best treatment approach or medication,” he said in a statement.

Lifestyle medication is critical for all patients with diabetes, according to Dr. Garber and the algorithm coauthors, who recommended a “primarily plant-based meal plan” that limits intake of saturated fatty acids and avoids trans fats. They said overweight patients should restrict caloric intake with a goal of reducing body weight by up to 10%.

Physical activity should include at least 150 minutes per week of activities such as brisk walking or weight training, they said, adding that patients should be advised to sleep 7 hours per night, on average.

Weight loss medications might be needed along with lifestyle modification for patients with body mass index (BMI) over 27 kg/m² with complications, and for all patients with BMI over 30 regardless of whether they have complications, according to the AACE/ACE committee members who drafted the report.

Bariatric surgery might be considered in patients with BMI over 35 and comorbidities, particularly if patients fail to achieve weight loss goals using other means, they added.

The primary goal of prediabetes management is weight loss, wrote the authors. While there are no Food and Drug Administration–approved agents for prediabetes management, they said, antihyperglycemic agents such as metformin and acarbose have been shown to reduce risk of diabetes by 25%-30% in patients with prediabetes.

While pressure control needs to be individualized, but a goal of less than 130/80 mm Hg is warranted for most patients with diabetes, according to the authors, who note that most patients will require medication to reach their goal.

“Because angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers can slow progression of nephropathy and retinopathy, they are preferred for patients with type 2 diabetes,” said Dr. Garber and his coauthors in the executive summary accompanying the algorithm.

Early and intensive management of dyslipidemia is important to reduce the significant risk of atherosclerotic cardiovascular disease in patients with diabetes, according to the authors, who say diabetes patients should be classified as high risk, very high risk, or extreme risk. They recommended LDL cholesterol targets of less than 100 mg/dL for high-risk patients, less than 70 mg/dL for very-high-risk patients, and less than 55 mg/dL for the extreme-risk group.

Statins should be considered first-line treatment for lowering cholesterol, unless contraindicated, with other lipid-modifying agents added as needed to reach lipid targets.

Inhibitors of proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9) address a “large unmet need” for more aggressive lipid lowering in patients with clinical atherosclerotic disease and diabetes, the authors noted.

Added to maximal statin therapy, PCSK9 inhibitors reduce LDL cholesterol by about 50% while also raising HDL cholesterol and having positive effects on other lipids, according to the authors.

Pharmacotherapy for type 2 diabetes requires a “nuanced approach” that takes into account factors such as age, comorbidities, and risk of hypoglycemia, the authors wrote, noting that the AACE supports a hemoglobin A1c target of 6.5% or less for most patients.

The algorithm for glycemic control lists glucose-lowering agents in order of recommended usage. For example, in patients with an entry HbA_1c less than 7.5%, the strongest recommendations for were monotherapy with metformin, followed by GLP1 receptor agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors.

If insulin becomes necessary, the recommended approach is to add a single daily dose of basal insulin, and if a basal insulin regimen fails to control glucose, it may help to add a GLP1 receptor agonist or dipeptidyl peptidase 4 (DPP4) inhibitor, according to the algorithm.

Avoiding hypoglycemia is important, and one possible “safety measure” to prevent that is using a continuous glucose monitoring device that provides real-time glucose data. “Significant advances have been made in accuracy and availability of CGM devices,” the authors wrote.

Current expert consensus is that clinical CGM devices should be considered if patients have not achieved their glycemic target after 3 months or if they need a treatment that puts them at risk for hypoglycemia, according to Dr. Garber and his colleagues.

Dr. Garber reported that he had no financial relationships relevant to the consensus statement and algorithm. Coauthors of the report provided disclosures related to Novo Nordisk, Eli Lilly, Janssen Pharmaceuticals, Abbott, Sanofi-Aventis, and other pharmaceutical companies.
 

[email protected]

SOURCE: Garber AJ et al. Endocr Pract. 2019 Jan;25(1):91-120.

For patients with extensive mild to moderate ulcerative colitis, numerous randomized controlled trials support the use of either standard-dose mesalamine (2-3 grams per day) or diazo-bonded 5-aminosalicylic acid (ASA) instead of low-dose mesalamine, sulfasalazine, or no therapy, state new guidelines from the American Gastroenterological Association, published in Gastroenterology.

©selvanegra/thinkstockphotos.com

Sulfasalazine (2-4 grams per day) is less likely to be tolerated but remains a “reasonable option” for remitted patients who are already on it and for patients with prominent arthritis symptoms, especially if alternative treatments are cost prohibitive, wrote Cynthia W. Ko, MD, MS, of the University of Washington, Seattle, and her associates.

According to the guideline, patients with mild to moderate ulcerative colitis have less than four to six bowel movements per day, only mild or moderate rectal bleeding, no constitutional symptoms, and no high overall inflammatory burden or signs of high inflammatory activity on the Mayo Clinic score and Truelove and Witt’s criteria. These patients usually do not require colectomy, but this outcome is more likely when patients are diagnosed before age 40 years or have extensive disease or deep ulcers, extraintestinal manifestations, or elevated inflammatory markers. These higher-risk patients need more aggressive initial treatment and faster treatment intensification in cases of inadequate response, the guideline emphasizes. Even for cases of mild to moderate ulcerative colitis, treatment intensification is preferable to repeated courses of corticosteroids.

The guideline recommends adding rectal mesalamine to oral 5-ASA if patients have extensive or left-sided mild to moderate ulcerative colitis. In randomized controlled trials, this combination was significantly more likely to induce and maintain remission than was standard-dose oral mesalamine monotherapy, the authors noted. “In the maintenance trials, enemas were used twice per week or for 1 week per month. Both oral and topical mesalamine were well tolerated.”

For patients with moderate disease activity or a suboptimal response to standard-dose mesalamine or diazo-bonded 5-ASA, the guideline recommends adding rectal mesalamine to high-dose oral mesalamine (more than 3 grams daily). Combination therapy maximizes the delivery of mesalamine to the affected area of the colon, which optimizes the trial of 5-ASA before opting for treatment escalation, the authors noted. They recommend once-daily oral mesalamine dosing, since this is easier to adhere to and studies have found no benefit of more frequent dosing.

For inducing remission of mild to moderate ulcerative colitis, the guideline recommends standard-dose oral mesalamine or diazo-bonded 5-ASA over budesonide. “Overall, the budesonide preparations are not superior to mesalamine for induction of remission,” the authors wrote. Oral 5-ASAs are preferred, especially given the absence of data on the efficacy or safety of maintenance budesonide therapy.

SOURCE: Crocket SD et al.  Gastro 2019;156(2).  doi: org/10.1053/j.gastro.2018.12.009.

For patients with extensive mild to moderate ulcerative colitis, numerous randomized controlled trials support the use of either standard-dose mesalamine (2-3 grams per day) or diazo-bonded 5-aminosalicylic acid (ASA) instead of low-dose mesalamine, sulfasalazine, or no therapy, state new guidelines from the American Gastroenterological Association, published in Gastroenterology.

©selvanegra/thinkstockphotos.com

Sulfasalazine (2-4 grams per day) is less likely to be tolerated but remains a “reasonable option” for remitted patients who are already on it and for patients with prominent arthritis symptoms, especially if alternative treatments are cost prohibitive, wrote Cynthia W. Ko, MD, MS, of the University of Washington, Seattle, and her associates.

According to the guideline, patients with mild to moderate ulcerative colitis have less than four to six bowel movements per day, only mild or moderate rectal bleeding, no constitutional symptoms, and no high overall inflammatory burden or signs of high inflammatory activity on the Mayo Clinic score and Truelove and Witt’s criteria. These patients usually do not require colectomy, but this outcome is more likely when patients are diagnosed before age 40 years or have extensive disease or deep ulcers, extraintestinal manifestations, or elevated inflammatory markers. These higher-risk patients need more aggressive initial treatment and faster treatment intensification in cases of inadequate response, the guideline emphasizes. Even for cases of mild to moderate ulcerative colitis, treatment intensification is preferable to repeated courses of corticosteroids.

The guideline recommends adding rectal mesalamine to oral 5-ASA if patients have extensive or left-sided mild to moderate ulcerative colitis. In randomized controlled trials, this combination was significantly more likely to induce and maintain remission than was standard-dose oral mesalamine monotherapy, the authors noted. “In the maintenance trials, enemas were used twice per week or for 1 week per month. Both oral and topical mesalamine were well tolerated.”

For patients with moderate disease activity or a suboptimal response to standard-dose mesalamine or diazo-bonded 5-ASA, the guideline recommends adding rectal mesalamine to high-dose oral mesalamine (more than 3 grams daily). Combination therapy maximizes the delivery of mesalamine to the affected area of the colon, which optimizes the trial of 5-ASA before opting for treatment escalation, the authors noted. They recommend once-daily oral mesalamine dosing, since this is easier to adhere to and studies have found no benefit of more frequent dosing.

For inducing remission of mild to moderate ulcerative colitis, the guideline recommends standard-dose oral mesalamine or diazo-bonded 5-ASA over budesonide. “Overall, the budesonide preparations are not superior to mesalamine for induction of remission,” the authors wrote. Oral 5-ASAs are preferred, especially given the absence of data on the efficacy or safety of maintenance budesonide therapy.

SOURCE: Crocket SD et al.  Gastro 2019;156(2).  doi: org/10.1053/j.gastro.2018.12.009.

For patients with extensive mild to moderate ulcerative colitis, numerous randomized controlled trials support the use of either standard-dose mesalamine (2-3 grams per day) or diazo-bonded 5-aminosalicylic acid (ASA) instead of low-dose mesalamine, sulfasalazine, or no therapy, state new guidelines from the American Gastroenterological Association, published in Gastroenterology.

©selvanegra/thinkstockphotos.com

Sulfasalazine (2-4 grams per day) is less likely to be tolerated but remains a “reasonable option” for remitted patients who are already on it and for patients with prominent arthritis symptoms, especially if alternative treatments are cost prohibitive, wrote Cynthia W. Ko, MD, MS, of the University of Washington, Seattle, and her associates.

According to the guideline, patients with mild to moderate ulcerative colitis have less than four to six bowel movements per day, only mild or moderate rectal bleeding, no constitutional symptoms, and no high overall inflammatory burden or signs of high inflammatory activity on the Mayo Clinic score and Truelove and Witt’s criteria. These patients usually do not require colectomy, but this outcome is more likely when patients are diagnosed before age 40 years or have extensive disease or deep ulcers, extraintestinal manifestations, or elevated inflammatory markers. These higher-risk patients need more aggressive initial treatment and faster treatment intensification in cases of inadequate response, the guideline emphasizes. Even for cases of mild to moderate ulcerative colitis, treatment intensification is preferable to repeated courses of corticosteroids.

The guideline recommends adding rectal mesalamine to oral 5-ASA if patients have extensive or left-sided mild to moderate ulcerative colitis. In randomized controlled trials, this combination was significantly more likely to induce and maintain remission than was standard-dose oral mesalamine monotherapy, the authors noted. “In the maintenance trials, enemas were used twice per week or for 1 week per month. Both oral and topical mesalamine were well tolerated.”

For patients with moderate disease activity or a suboptimal response to standard-dose mesalamine or diazo-bonded 5-ASA, the guideline recommends adding rectal mesalamine to high-dose oral mesalamine (more than 3 grams daily). Combination therapy maximizes the delivery of mesalamine to the affected area of the colon, which optimizes the trial of 5-ASA before opting for treatment escalation, the authors noted. They recommend once-daily oral mesalamine dosing, since this is easier to adhere to and studies have found no benefit of more frequent dosing.

For inducing remission of mild to moderate ulcerative colitis, the guideline recommends standard-dose oral mesalamine or diazo-bonded 5-ASA over budesonide. “Overall, the budesonide preparations are not superior to mesalamine for induction of remission,” the authors wrote. Oral 5-ASAs are preferred, especially given the absence of data on the efficacy or safety of maintenance budesonide therapy.

SOURCE: Crocket SD et al.  Gastro 2019;156(2).  doi: org/10.1053/j.gastro.2018.12.009.

The purpose of this guideline is to provide direction for the management of patients with high blood cholesterol to decrease the incidence of atherosclerotic vascular disease. The update was undertaken because new evidence has emerged since the publication of the 2013 ACC/AHA cholesterol guideline about additional cholesterol-lowering agents including ezetimibe and PCSK9 inhibitors.

Measurement and therapeutic modalities

In adults aged 20 years and older who are not on lipid-lowering therapy, measurement of a lipid profile is recommended and is an effective way to estimate atherosclerotic cardiovascular disease (ASCVD) risk and documenting baseline LDL-C.

Statin therapy is divided into three categories: High-intensity statin therapy aims for lowering LDL-C levels by more than 50%, moderate-intensity therapy by 30%-49%, and low-intensity therapy by less than 30%.
 

Cholesterol management groups

In all individuals at all ages, emphasizing a heart-healthy lifestyle, meaning appropriate diet and exercise, to decrease the risk of developing ASCVD should be advised.

Individuals fall into groups with distinct risk of ASCVD or recurrence of ASCVD and the recommendations are organized according to these risk groups.

Secondary ASCVD prevention: Patients who already have ASCVD by virtue of having had an event or established diagnosis (MI, angina, cerebrovascular accident, or peripheral vascular disease) fall into the secondary prevention category:

• Patients aged 75 years and younger with clinical ASCVD: High-intensity statin therapy should be initiated with aim to reduce LDL-C levels by 50%. In patients who experience statin-related side effects, a moderate-intensity statin should be initiated with the aim to reduce LDL-C by 30%-49%.
• In very high-risk patients with an LDL-C above 70 mg/dL on maximally tolerated statin therapy, it is reasonable to consider the use of a non–statin cholesterol-lowering agent with an LDL-C goal under 70 mg/dL. Ezetimibe (Zetia) can be used initially and if LDL-C remains above 70 mg/dL, then consideration can be given to the addition of a PCSK9-inhibitor therapy (strength of recommendation: ezetimibe – moderate; PCSK9 – strong). The guideline discusses that, even though the evidence supports the efficacy of PCSK9s in reducing the incidence of ASCVD events, the expense of PCSK9 inhibitors give them a high cost, compared with value.
• For patients more than age 75 years with established ASCVD, it is reasonable to continue high-intensity statin therapy if patient is tolerating treatment.

Severe hypercholesterolemia:

• Patients with LDL-C above 190 mg/dL do not need a 10-year risk score calculated. These individuals should receive maximally tolerated statin therapy.
• If patient is unable to achieve 50% reduction in LDL-C and/or have an LDL-C level of 100 mg/dL, the addition of ezetimibe therapy is reasonable.
• If LDL-C is still greater than 100mg/dL on a statin plus ezetimibe, the addition of a PCSK9 inhibitor may be considered. It should be recognized that the addition of a PCSK9 in this circumstance is classified as a weak recommendation.

Diabetes mellitus in adults:

• In patients aged 40-75 years with diabetes, regardless of 10-year ASCVD risk, should be prescribed a moderate-intensity statin (strong recommendation).
• In adults with diabetes mellitus and multiple ASCVD risk factors, it is reasonable to prescribe high-intensity statin therapy with goal to reduce LDL-C by more than 50%.
• In adults with diabetes mellitus and 10-year ASCVD risk of 20% or higher, it may be reasonable to add ezetimibe to maximally tolerated statin therapy to reduce LDL-C levels by 50% or more.
• In patients aged 20-39 years with diabetes that is either of long duration (at least 10 years, type 2 diabetes mellitus; at least 20 years, type 1 diabetes mellitus), or with end-organ damage including albuminuria, chronic renal insufficiency, retinopathy, neuropathy, or ankle-brachial index below 0.9, it may be reasonable to initiate statin therapy (weak recommendation).

Primary prevention in adults: Adults with LDL 70-189 mg/dL and a 10-year risk of a first ASCVD event (fatal and nonfatal MI or stroke) should be estimated by using the pooled cohort equation. Adults should be categorized according to calculated risk of developing ASCVD: low risk (less than 5%), borderline risk (5% to less than 7.5%), intermediate risk (7.5% and higher to less than 20%), and high risk (20% and higher) (strong recommendation:

• Individualized risk and treatment discussion should be done with clinician and patient.
• Adults in the intermediate-risk group (7.5% and higher to less than 20%), should be placed on moderate-intensity statin with LDL-C goal reduction of more than 30%; for optimal risk reduction, especially in high-risk patients, an LDL-C reduction of more than 50% (strong recommendation).
• Risk-enhancing factors can favor initiation of intensification of statin therapy.
• If a decision about statin therapy is uncertain, consider measuring coronary artery calcium (CAC) levels. If CAC is zero, statin therapy may be withheld or delayed, except those with diabetes as above, smokers, and strong familial hypercholesterolemia with premature ASCVD. If CAC score is 1-99, it is reasonable to initiate statin therapy for patients older than age 55 years; If CAC score is 100 or higher or in the 75th percentile or higher, it is reasonable to initiate a statin.

Statin safety: Prior to initiation of a statin, a clinician-patient discussion is recommended detailing ASCVD risk reduction and the potential for side effects/drug interactions. In patients with statin-associated muscle symptoms (SAMS), a detailed account for secondary causes is recommended. In patients with true SAMS, it is recommended to check a creatine kinase level and hepatic function panel; however, routine measurements are not useful. In patients with statin-associated side effects that are not severe, reassess and rechallenge patient to achieve maximal lowering of LDL-C with a modified dosing regimen.
 

The bottom line

Lifestyle modification is important at all ages, with specific population-guided strategies for lowering cholesterol in subgroups as discussed above. Major changes to the AHA/ACC Cholesterol Clinical Practice Guidelines now mention new agents for lowering cholesterol and using CAC levels as predictability scoring.

Reference

Grundy SM et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the management of blood cholesterol: Executive Summary: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018 Nov 10.

Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Palko is a second-year resident in the family medicine residency program at Abington Jefferson Hospital.

The purpose of this guideline is to provide direction for the management of patients with high blood cholesterol to decrease the incidence of atherosclerotic vascular disease. The update was undertaken because new evidence has emerged since the publication of the 2013 ACC/AHA cholesterol guideline about additional cholesterol-lowering agents including ezetimibe and PCSK9 inhibitors.

Measurement and therapeutic modalities

In adults aged 20 years and older who are not on lipid-lowering therapy, measurement of a lipid profile is recommended and is an effective way to estimate atherosclerotic cardiovascular disease (ASCVD) risk and documenting baseline LDL-C.

Statin therapy is divided into three categories: High-intensity statin therapy aims for lowering LDL-C levels by more than 50%, moderate-intensity therapy by 30%-49%, and low-intensity therapy by less than 30%.
 

Cholesterol management groups

In all individuals at all ages, emphasizing a heart-healthy lifestyle, meaning appropriate diet and exercise, to decrease the risk of developing ASCVD should be advised.

Individuals fall into groups with distinct risk of ASCVD or recurrence of ASCVD and the recommendations are organized according to these risk groups.

Secondary ASCVD prevention: Patients who already have ASCVD by virtue of having had an event or established diagnosis (MI, angina, cerebrovascular accident, or peripheral vascular disease) fall into the secondary prevention category:

• Patients aged 75 years and younger with clinical ASCVD: High-intensity statin therapy should be initiated with aim to reduce LDL-C levels by 50%. In patients who experience statin-related side effects, a moderate-intensity statin should be initiated with the aim to reduce LDL-C by 30%-49%.
• In very high-risk patients with an LDL-C above 70 mg/dL on maximally tolerated statin therapy, it is reasonable to consider the use of a non–statin cholesterol-lowering agent with an LDL-C goal under 70 mg/dL. Ezetimibe (Zetia) can be used initially and if LDL-C remains above 70 mg/dL, then consideration can be given to the addition of a PCSK9-inhibitor therapy (strength of recommendation: ezetimibe – moderate; PCSK9 – strong). The guideline discusses that, even though the evidence supports the efficacy of PCSK9s in reducing the incidence of ASCVD events, the expense of PCSK9 inhibitors give them a high cost, compared with value.
• For patients more than age 75 years with established ASCVD, it is reasonable to continue high-intensity statin therapy if patient is tolerating treatment.

Severe hypercholesterolemia:

• Patients with LDL-C above 190 mg/dL do not need a 10-year risk score calculated. These individuals should receive maximally tolerated statin therapy.
• If patient is unable to achieve 50% reduction in LDL-C and/or have an LDL-C level of 100 mg/dL, the addition of ezetimibe therapy is reasonable.
• If LDL-C is still greater than 100mg/dL on a statin plus ezetimibe, the addition of a PCSK9 inhibitor may be considered. It should be recognized that the addition of a PCSK9 in this circumstance is classified as a weak recommendation.

Diabetes mellitus in adults:

• In patients aged 40-75 years with diabetes, regardless of 10-year ASCVD risk, should be prescribed a moderate-intensity statin (strong recommendation).
• In adults with diabetes mellitus and multiple ASCVD risk factors, it is reasonable to prescribe high-intensity statin therapy with goal to reduce LDL-C by more than 50%.
• In adults with diabetes mellitus and 10-year ASCVD risk of 20% or higher, it may be reasonable to add ezetimibe to maximally tolerated statin therapy to reduce LDL-C levels by 50% or more.
• In patients aged 20-39 years with diabetes that is either of long duration (at least 10 years, type 2 diabetes mellitus; at least 20 years, type 1 diabetes mellitus), or with end-organ damage including albuminuria, chronic renal insufficiency, retinopathy, neuropathy, or ankle-brachial index below 0.9, it may be reasonable to initiate statin therapy (weak recommendation).

Primary prevention in adults: Adults with LDL 70-189 mg/dL and a 10-year risk of a first ASCVD event (fatal and nonfatal MI or stroke) should be estimated by using the pooled cohort equation. Adults should be categorized according to calculated risk of developing ASCVD: low risk (less than 5%), borderline risk (5% to less than 7.5%), intermediate risk (7.5% and higher to less than 20%), and high risk (20% and higher) (strong recommendation:

• Individualized risk and treatment discussion should be done with clinician and patient.
• Adults in the intermediate-risk group (7.5% and higher to less than 20%), should be placed on moderate-intensity statin with LDL-C goal reduction of more than 30%; for optimal risk reduction, especially in high-risk patients, an LDL-C reduction of more than 50% (strong recommendation).
• Risk-enhancing factors can favor initiation of intensification of statin therapy.
• If a decision about statin therapy is uncertain, consider measuring coronary artery calcium (CAC) levels. If CAC is zero, statin therapy may be withheld or delayed, except those with diabetes as above, smokers, and strong familial hypercholesterolemia with premature ASCVD. If CAC score is 1-99, it is reasonable to initiate statin therapy for patients older than age 55 years; If CAC score is 100 or higher or in the 75th percentile or higher, it is reasonable to initiate a statin.

Statin safety: Prior to initiation of a statin, a clinician-patient discussion is recommended detailing ASCVD risk reduction and the potential for side effects/drug interactions. In patients with statin-associated muscle symptoms (SAMS), a detailed account for secondary causes is recommended. In patients with true SAMS, it is recommended to check a creatine kinase level and hepatic function panel; however, routine measurements are not useful. In patients with statin-associated side effects that are not severe, reassess and rechallenge patient to achieve maximal lowering of LDL-C with a modified dosing regimen.
 

The bottom line

Lifestyle modification is important at all ages, with specific population-guided strategies for lowering cholesterol in subgroups as discussed above. Major changes to the AHA/ACC Cholesterol Clinical Practice Guidelines now mention new agents for lowering cholesterol and using CAC levels as predictability scoring.

Reference

Grundy SM et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the management of blood cholesterol: Executive Summary: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018 Nov 10.

Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Palko is a second-year resident in the family medicine residency program at Abington Jefferson Hospital.

The purpose of this guideline is to provide direction for the management of patients with high blood cholesterol to decrease the incidence of atherosclerotic vascular disease. The update was undertaken because new evidence has emerged since the publication of the 2013 ACC/AHA cholesterol guideline about additional cholesterol-lowering agents including ezetimibe and PCSK9 inhibitors.

Measurement and therapeutic modalities

In adults aged 20 years and older who are not on lipid-lowering therapy, measurement of a lipid profile is recommended and is an effective way to estimate atherosclerotic cardiovascular disease (ASCVD) risk and documenting baseline LDL-C.

Statin therapy is divided into three categories: High-intensity statin therapy aims for lowering LDL-C levels by more than 50%, moderate-intensity therapy by 30%-49%, and low-intensity therapy by less than 30%.
 

Cholesterol management groups

In all individuals at all ages, emphasizing a heart-healthy lifestyle, meaning appropriate diet and exercise, to decrease the risk of developing ASCVD should be advised.

Individuals fall into groups with distinct risk of ASCVD or recurrence of ASCVD and the recommendations are organized according to these risk groups.

Secondary ASCVD prevention: Patients who already have ASCVD by virtue of having had an event or established diagnosis (MI, angina, cerebrovascular accident, or peripheral vascular disease) fall into the secondary prevention category:

• Patients aged 75 years and younger with clinical ASCVD: High-intensity statin therapy should be initiated with aim to reduce LDL-C levels by 50%. In patients who experience statin-related side effects, a moderate-intensity statin should be initiated with the aim to reduce LDL-C by 30%-49%.
• In very high-risk patients with an LDL-C above 70 mg/dL on maximally tolerated statin therapy, it is reasonable to consider the use of a non–statin cholesterol-lowering agent with an LDL-C goal under 70 mg/dL. Ezetimibe (Zetia) can be used initially and if LDL-C remains above 70 mg/dL, then consideration can be given to the addition of a PCSK9-inhibitor therapy (strength of recommendation: ezetimibe – moderate; PCSK9 – strong). The guideline discusses that, even though the evidence supports the efficacy of PCSK9s in reducing the incidence of ASCVD events, the expense of PCSK9 inhibitors give them a high cost, compared with value.
• For patients more than age 75 years with established ASCVD, it is reasonable to continue high-intensity statin therapy if patient is tolerating treatment.

Severe hypercholesterolemia:

• Patients with LDL-C above 190 mg/dL do not need a 10-year risk score calculated. These individuals should receive maximally tolerated statin therapy.
• If patient is unable to achieve 50% reduction in LDL-C and/or have an LDL-C level of 100 mg/dL, the addition of ezetimibe therapy is reasonable.
• If LDL-C is still greater than 100mg/dL on a statin plus ezetimibe, the addition of a PCSK9 inhibitor may be considered. It should be recognized that the addition of a PCSK9 in this circumstance is classified as a weak recommendation.

Diabetes mellitus in adults:

• In patients aged 40-75 years with diabetes, regardless of 10-year ASCVD risk, should be prescribed a moderate-intensity statin (strong recommendation).
• In adults with diabetes mellitus and multiple ASCVD risk factors, it is reasonable to prescribe high-intensity statin therapy with goal to reduce LDL-C by more than 50%.
• In adults with diabetes mellitus and 10-year ASCVD risk of 20% or higher, it may be reasonable to add ezetimibe to maximally tolerated statin therapy to reduce LDL-C levels by 50% or more.
• In patients aged 20-39 years with diabetes that is either of long duration (at least 10 years, type 2 diabetes mellitus; at least 20 years, type 1 diabetes mellitus), or with end-organ damage including albuminuria, chronic renal insufficiency, retinopathy, neuropathy, or ankle-brachial index below 0.9, it may be reasonable to initiate statin therapy (weak recommendation).

Primary prevention in adults: Adults with LDL 70-189 mg/dL and a 10-year risk of a first ASCVD event (fatal and nonfatal MI or stroke) should be estimated by using the pooled cohort equation. Adults should be categorized according to calculated risk of developing ASCVD: low risk (less than 5%), borderline risk (5% to less than 7.5%), intermediate risk (7.5% and higher to less than 20%), and high risk (20% and higher) (strong recommendation:

• Individualized risk and treatment discussion should be done with clinician and patient.
• Adults in the intermediate-risk group (7.5% and higher to less than 20%), should be placed on moderate-intensity statin with LDL-C goal reduction of more than 30%; for optimal risk reduction, especially in high-risk patients, an LDL-C reduction of more than 50% (strong recommendation).
• Risk-enhancing factors can favor initiation of intensification of statin therapy.
• If a decision about statin therapy is uncertain, consider measuring coronary artery calcium (CAC) levels. If CAC is zero, statin therapy may be withheld or delayed, except those with diabetes as above, smokers, and strong familial hypercholesterolemia with premature ASCVD. If CAC score is 1-99, it is reasonable to initiate statin therapy for patients older than age 55 years; If CAC score is 100 or higher or in the 75th percentile or higher, it is reasonable to initiate a statin.

Statin safety: Prior to initiation of a statin, a clinician-patient discussion is recommended detailing ASCVD risk reduction and the potential for side effects/drug interactions. In patients with statin-associated muscle symptoms (SAMS), a detailed account for secondary causes is recommended. In patients with true SAMS, it is recommended to check a creatine kinase level and hepatic function panel; however, routine measurements are not useful. In patients with statin-associated side effects that are not severe, reassess and rechallenge patient to achieve maximal lowering of LDL-C with a modified dosing regimen.
 

The bottom line

Lifestyle modification is important at all ages, with specific population-guided strategies for lowering cholesterol in subgroups as discussed above. Major changes to the AHA/ACC Cholesterol Clinical Practice Guidelines now mention new agents for lowering cholesterol and using CAC levels as predictability scoring.

Reference

Grundy SM et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the management of blood cholesterol: Executive Summary: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018 Nov 10.

Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Palko is a second-year resident in the family medicine residency program at Abington Jefferson Hospital.

The first update to U.S. medical-society guidelines for managing atrial fibrillation since 2014 raised the threshold for starting anticoagulant therapy in women, pegged the direct-acting oral anticoagulants (DOACs) as preferred over warfarin, and introduced for the first time weight loss as an important intervention tool for treating patients with an atrial arrhythmia.

Mitchel L. Zoler/MDedge News

On January 28, the American College of Cardiology, American Heart Association, and Heart Rhythm Society posted online a 2019 focused update (Circulation. 2019 Jan 28. doi: 10.1161/CIR.0000000000000665) to the 2014 atrial fibrillation (AF) management guidelines that the groups had previously published (J Am Coll Cardiol. 2014 Dec 2;64[21]:2246-80).

Perhaps the two most important changes, as well as the two that lead off the new document, were a pair of class I recommendations on using oral anticoagulation in AF patients.

One of these updates reset the threshold for initiating oral anticoagulant therapy in women from 2 points on the CHA2DS2-VASc scale to 3 points, while leaving the threshold for men unchanged at 2 points. This brought U.S. guidelines in line with European guidelines, set by the European Society of Cardiology in 2016 (Eur Heart J. 2016 Oct 7;37[38]:2893-962). It will now also mean that, because of the way the CHA2DS2-VASc score is calculated, women with AF who are at least 65 years old will no longer automatically get flagged as needing oral anticoagulant therapy.

“This is a really important shift. It’s recognition that female sex is not as important a risk factor [for AF-associated stroke] as once was thought,” commented Hugh Calkins, MD, professor of medicine at Johns Hopkins Medicine in Baltimore and a member of the panel that wrote the update. “This will change the number of women with AF who go on anticoagulation,” predicted Dr. Calkins, who directs the cardiac arrhythmia service at his center. “We have been struggling with the notion that all women 65 or older with AF had to be on an anticoagulant. Now a clinician has more leeway. In general, patients with AF remain underanticoagulated, but this clarifies practice and brings us in line with the European guidelines.”

The second important change to the anticoagulation recommendations was to specify the DOACs as recommended over warfarin in AF patients eligible for oral anticoagulation and without moderate to severe mitral stenosis or a mechanical heart valve, which also matches the 2016 European guidelines and updates the prior, 2014, U.S. guidelines, which didn’t even mention DOACs.

Prescribing a DOAC preferentially to AF patients has already become routine among electrophysiologists, but possibly not as routine among primary care physicians, so this change has the potential to shift practice, said Dr. Calkins. But the higher price for DOACs, compared with warfarin, can pose problems. “The cost of DOACs remains an issue that can be a serious limitation to some patients,” said Craig T. January, MD, professor of medicine at the University of Wisconsin in Madison and chair of the guideline-writing panel. He also bemoaned the absence of head-to-head comparisons of individual DOACs that could inform selecting among apixaban, dabigatran, edoxaban, and rivaroxaban.

Another notable change in the 2019 update was inclusion for the first time of weight loss as a recommended intervention, along with other risk factor modification, an addition that Dr. Calkins called “long overdue.”

Mitchel L. Zoler/MDedge News

“This is a new recommendation, and it will potentially be important,” said Dr. January, although the guidelines do not spell out how aggressive clinicians should be about having patients achieve weight loss, how much loss patients should achieve, or how they should do it. “There are a lot of observational data and basic science data suggesting the importance of weight loss. Most electrophysiologists already address weight loss. The problem is how to get patients to do it,” commented Vivek Reddy, MD, professor of medicine and director of cardiac arrhythmia services at Mount Sinai Hospital in New York.

Dr. Reddy expressed surprise over two other features of the updated guidelines. For the first time, the guidelines now address percutaneous left atrial appendage (LAA) occlusion and say: “Percutaneous LAA occlusion may be considered in patients with AF at increased risk of stroke who have contraindications to long-term anticoagulation.” The guidelines’ text acknowledges that this runs counter to the Food and Drug Administration labeling for the Watchman LAA occlusion device, which restricts the device to patients “deemed suitable for long-term warfarin (mirroring the inclusion criteria for enrollment in the clinical trials) but had an appropriate rationale to seek a nonpharmacological alternative to warfarin.”

“We do not take a position on the FDA’s” actions, Dr. January said in an interview.

“The ACC, AHA, and HRS guidelines should reflect what the FDA decided,” Dr. Reddy said in an interview. “I’m a little surprised the guidelines said that anticoagulation had to be contraindicated.

The 2019 update also added a class IIb, “may be reasonable” recommendation for catheter ablation of AF in patients with heart failure with reduced ejection fraction.

“I think a IIb recommendation is unfair; I think it should be a IIa recommendation because there have been positive results from two large, randomized, multicenter trials – CASTLE-AF [Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF; N Engl J Med. 2018 Feb 1;378(5):417-27] and AATAC [Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD; Circulation. 2016 Apr 26;133(7):1637-44], as well as positive results from several smaller randomized studies,” Dr. Reddy said. “I’m really surprised” that the recommendation was not stronger.

Dr. Calkins has been a consultant to Abbott, Altathera, AtriCare, Boehringer-Ingelheim, King, Medtronic, and St. Jude and has received research funding from Boehringer-Ingelheim, Boston Scientific, and St. Jude. Dr. January had no disclosures. Dr. Reddy has been a consultant to, received research funding from, or has an equity interest in more than three dozen companies.

[email protected]

The first update to U.S. medical-society guidelines for managing atrial fibrillation since 2014 raised the threshold for starting anticoagulant therapy in women, pegged the direct-acting oral anticoagulants (DOACs) as preferred over warfarin, and introduced for the first time weight loss as an important intervention tool for treating patients with an atrial arrhythmia.

Mitchel L. Zoler/MDedge News

On January 28, the American College of Cardiology, American Heart Association, and Heart Rhythm Society posted online a 2019 focused update (Circulation. 2019 Jan 28. doi: 10.1161/CIR.0000000000000665) to the 2014 atrial fibrillation (AF) management guidelines that the groups had previously published (J Am Coll Cardiol. 2014 Dec 2;64[21]:2246-80).

Perhaps the two most important changes, as well as the two that lead off the new document, were a pair of class I recommendations on using oral anticoagulation in AF patients.

One of these updates reset the threshold for initiating oral anticoagulant therapy in women from 2 points on the CHA2DS2-VASc scale to 3 points, while leaving the threshold for men unchanged at 2 points. This brought U.S. guidelines in line with European guidelines, set by the European Society of Cardiology in 2016 (Eur Heart J. 2016 Oct 7;37[38]:2893-962). It will now also mean that, because of the way the CHA2DS2-VASc score is calculated, women with AF who are at least 65 years old will no longer automatically get flagged as needing oral anticoagulant therapy.

“This is a really important shift. It’s recognition that female sex is not as important a risk factor [for AF-associated stroke] as once was thought,” commented Hugh Calkins, MD, professor of medicine at Johns Hopkins Medicine in Baltimore and a member of the panel that wrote the update. “This will change the number of women with AF who go on anticoagulation,” predicted Dr. Calkins, who directs the cardiac arrhythmia service at his center. “We have been struggling with the notion that all women 65 or older with AF had to be on an anticoagulant. Now a clinician has more leeway. In general, patients with AF remain underanticoagulated, but this clarifies practice and brings us in line with the European guidelines.”

The second important change to the anticoagulation recommendations was to specify the DOACs as recommended over warfarin in AF patients eligible for oral anticoagulation and without moderate to severe mitral stenosis or a mechanical heart valve, which also matches the 2016 European guidelines and updates the prior, 2014, U.S. guidelines, which didn’t even mention DOACs.

Prescribing a DOAC preferentially to AF patients has already become routine among electrophysiologists, but possibly not as routine among primary care physicians, so this change has the potential to shift practice, said Dr. Calkins. But the higher price for DOACs, compared with warfarin, can pose problems. “The cost of DOACs remains an issue that can be a serious limitation to some patients,” said Craig T. January, MD, professor of medicine at the University of Wisconsin in Madison and chair of the guideline-writing panel. He also bemoaned the absence of head-to-head comparisons of individual DOACs that could inform selecting among apixaban, dabigatran, edoxaban, and rivaroxaban.

Another notable change in the 2019 update was inclusion for the first time of weight loss as a recommended intervention, along with other risk factor modification, an addition that Dr. Calkins called “long overdue.”

Mitchel L. Zoler/MDedge News

“This is a new recommendation, and it will potentially be important,” said Dr. January, although the guidelines do not spell out how aggressive clinicians should be about having patients achieve weight loss, how much loss patients should achieve, or how they should do it. “There are a lot of observational data and basic science data suggesting the importance of weight loss. Most electrophysiologists already address weight loss. The problem is how to get patients to do it,” commented Vivek Reddy, MD, professor of medicine and director of cardiac arrhythmia services at Mount Sinai Hospital in New York.

Dr. Reddy expressed surprise over two other features of the updated guidelines. For the first time, the guidelines now address percutaneous left atrial appendage (LAA) occlusion and say: “Percutaneous LAA occlusion may be considered in patients with AF at increased risk of stroke who have contraindications to long-term anticoagulation.” The guidelines’ text acknowledges that this runs counter to the Food and Drug Administration labeling for the Watchman LAA occlusion device, which restricts the device to patients “deemed suitable for long-term warfarin (mirroring the inclusion criteria for enrollment in the clinical trials) but had an appropriate rationale to seek a nonpharmacological alternative to warfarin.”

“We do not take a position on the FDA’s” actions, Dr. January said in an interview.

“The ACC, AHA, and HRS guidelines should reflect what the FDA decided,” Dr. Reddy said in an interview. “I’m a little surprised the guidelines said that anticoagulation had to be contraindicated.

The 2019 update also added a class IIb, “may be reasonable” recommendation for catheter ablation of AF in patients with heart failure with reduced ejection fraction.

“I think a IIb recommendation is unfair; I think it should be a IIa recommendation because there have been positive results from two large, randomized, multicenter trials – CASTLE-AF [Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF; N Engl J Med. 2018 Feb 1;378(5):417-27] and AATAC [Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD; Circulation. 2016 Apr 26;133(7):1637-44], as well as positive results from several smaller randomized studies,” Dr. Reddy said. “I’m really surprised” that the recommendation was not stronger.

Dr. Calkins has been a consultant to Abbott, Altathera, AtriCare, Boehringer-Ingelheim, King, Medtronic, and St. Jude and has received research funding from Boehringer-Ingelheim, Boston Scientific, and St. Jude. Dr. January had no disclosures. Dr. Reddy has been a consultant to, received research funding from, or has an equity interest in more than three dozen companies.

[email protected]

The first update to U.S. medical-society guidelines for managing atrial fibrillation since 2014 raised the threshold for starting anticoagulant therapy in women, pegged the direct-acting oral anticoagulants (DOACs) as preferred over warfarin, and introduced for the first time weight loss as an important intervention tool for treating patients with an atrial arrhythmia.

Mitchel L. Zoler/MDedge News

On January 28, the American College of Cardiology, American Heart Association, and Heart Rhythm Society posted online a 2019 focused update (Circulation. 2019 Jan 28. doi: 10.1161/CIR.0000000000000665) to the 2014 atrial fibrillation (AF) management guidelines that the groups had previously published (J Am Coll Cardiol. 2014 Dec 2;64[21]:2246-80).

Perhaps the two most important changes, as well as the two that lead off the new document, were a pair of class I recommendations on using oral anticoagulation in AF patients.

One of these updates reset the threshold for initiating oral anticoagulant therapy in women from 2 points on the CHA2DS2-VASc scale to 3 points, while leaving the threshold for men unchanged at 2 points. This brought U.S. guidelines in line with European guidelines, set by the European Society of Cardiology in 2016 (Eur Heart J. 2016 Oct 7;37[38]:2893-962). It will now also mean that, because of the way the CHA2DS2-VASc score is calculated, women with AF who are at least 65 years old will no longer automatically get flagged as needing oral anticoagulant therapy.

“This is a really important shift. It’s recognition that female sex is not as important a risk factor [for AF-associated stroke] as once was thought,” commented Hugh Calkins, MD, professor of medicine at Johns Hopkins Medicine in Baltimore and a member of the panel that wrote the update. “This will change the number of women with AF who go on anticoagulation,” predicted Dr. Calkins, who directs the cardiac arrhythmia service at his center. “We have been struggling with the notion that all women 65 or older with AF had to be on an anticoagulant. Now a clinician has more leeway. In general, patients with AF remain underanticoagulated, but this clarifies practice and brings us in line with the European guidelines.”

The second important change to the anticoagulation recommendations was to specify the DOACs as recommended over warfarin in AF patients eligible for oral anticoagulation and without moderate to severe mitral stenosis or a mechanical heart valve, which also matches the 2016 European guidelines and updates the prior, 2014, U.S. guidelines, which didn’t even mention DOACs.

Prescribing a DOAC preferentially to AF patients has already become routine among electrophysiologists, but possibly not as routine among primary care physicians, so this change has the potential to shift practice, said Dr. Calkins. But the higher price for DOACs, compared with warfarin, can pose problems. “The cost of DOACs remains an issue that can be a serious limitation to some patients,” said Craig T. January, MD, professor of medicine at the University of Wisconsin in Madison and chair of the guideline-writing panel. He also bemoaned the absence of head-to-head comparisons of individual DOACs that could inform selecting among apixaban, dabigatran, edoxaban, and rivaroxaban.

Another notable change in the 2019 update was inclusion for the first time of weight loss as a recommended intervention, along with other risk factor modification, an addition that Dr. Calkins called “long overdue.”

Mitchel L. Zoler/MDedge News

“This is a new recommendation, and it will potentially be important,” said Dr. January, although the guidelines do not spell out how aggressive clinicians should be about having patients achieve weight loss, how much loss patients should achieve, or how they should do it. “There are a lot of observational data and basic science data suggesting the importance of weight loss. Most electrophysiologists already address weight loss. The problem is how to get patients to do it,” commented Vivek Reddy, MD, professor of medicine and director of cardiac arrhythmia services at Mount Sinai Hospital in New York.

Dr. Reddy expressed surprise over two other features of the updated guidelines. For the first time, the guidelines now address percutaneous left atrial appendage (LAA) occlusion and say: “Percutaneous LAA occlusion may be considered in patients with AF at increased risk of stroke who have contraindications to long-term anticoagulation.” The guidelines’ text acknowledges that this runs counter to the Food and Drug Administration labeling for the Watchman LAA occlusion device, which restricts the device to patients “deemed suitable for long-term warfarin (mirroring the inclusion criteria for enrollment in the clinical trials) but had an appropriate rationale to seek a nonpharmacological alternative to warfarin.”

“We do not take a position on the FDA’s” actions, Dr. January said in an interview.

“The ACC, AHA, and HRS guidelines should reflect what the FDA decided,” Dr. Reddy said in an interview. “I’m a little surprised the guidelines said that anticoagulation had to be contraindicated.

The 2019 update also added a class IIb, “may be reasonable” recommendation for catheter ablation of AF in patients with heart failure with reduced ejection fraction.

“I think a IIb recommendation is unfair; I think it should be a IIa recommendation because there have been positive results from two large, randomized, multicenter trials – CASTLE-AF [Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF; N Engl J Med. 2018 Feb 1;378(5):417-27] and AATAC [Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD; Circulation. 2016 Apr 26;133(7):1637-44], as well as positive results from several smaller randomized studies,” Dr. Reddy said. “I’m really surprised” that the recommendation was not stronger.

Dr. Calkins has been a consultant to Abbott, Altathera, AtriCare, Boehringer-Ingelheim, King, Medtronic, and St. Jude and has received research funding from Boehringer-Ingelheim, Boston Scientific, and St. Jude. Dr. January had no disclosures. Dr. Reddy has been a consultant to, received research funding from, or has an equity interest in more than three dozen companies.

[email protected]

Fertility preservation, imaging and radiotherapy guidelines, and best practices in relapse or salvage therapy for primary mediastinal B-cell lymphoma (PMBCL) are all highlighted in a new good practice paper from the British Society for Haematology.

Though PMBCL was previously thought of as a subtype of diffuse large B-cell lymphoma, “gene expression profiling data has shown it to be a separate clinicopathological entity with evidence of an overlap with classic Hodgkin lymphoma,” said Kate Cwynarski, MD, PhD, of University College London Hospitals NHS Foundation Trust in England, and her coauthors. The recommendations were published in the British Journal of Haematology.

PMBCL makes up 2%-4% of non-Hodgkin lymphomas, they said; a bulky anterior mediastinal mass is the usual initial presentation. PMBCL does not usually spread beyond the thoracic cavity.

Biopsy, which should be reviewed by a hematopathologist, is required for a histological diagnosis of PMBCL. A multidisciplinary team should review the clinical presentation, pathology, and management plan, according to the good practice paper authors. This was a strong recommendation backed by a high level of evidence.

In addition, patients should receive positron emission tomography–computed tomography (PET/CT) at diagnosis, before steroids are administered, if possible, as standard of care. Results from the PET/CT should be reported in accordance with international guidelines. These strong recommendations are backed by high-quality evidence.

If PET/CT is performed, then “a bone marrow biopsy is not considered essential,” said Dr. Cwynarski and her coauthors. However, if the findings would influence management, such as when there is extranodal disease that presents central nervous system opportunities, then bone marrow biopsy should be performed. It should also be performed when cytotoxic therapy was initiated before PET/CT could be done. This is a weak recommendation supported by moderate evidence.

Since patients with PMBCL are usually young adults at presentation, it’s important to consider fertility preservation in the face of chemotherapy. For males, semen preservation should be offered. Female patients may not be able to postpone treatment long enough to accomplish egg harvesting. The risk of infertility and premature ovarian failure will depend on the treatment regimen, so “the risks of each individual therapeutic regimen should be discussed with the patient,” Dr. Cwynarski and her colleagues said.

If a patient is diagnosed with PMBCL while pregnant, treatment should be managed in conjunction with high-risk obstetrics and anesthesia specialists. Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) has been used in pregnancy, and immunotherapy without antimetabolites can be considered in the second and third trimesters, according to the good practice paper. These are strong fertility and pregnancy recommendations, backed by moderate to low-quality evidence.

If superior vena cava obstruction causes thrombosis, local standard of care for anticoagulation should be used, but therapy-induced thrombocytopenia should be taken into consideration.

There is a lack of prospective, randomized studies to guide treatment decisions in PMBCL, according to the paper. Still, adding rituximab improves both response rates and duration of remission, they noted.

The standard of care for treatment is six cycles of R-CHOP and involved site radiotherapy (ISRT). If the patient is being cared for at a site that can manage the complexities of dose adjustment and monitoring, dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) without ISRT is an alternative, according to the good practice paper.

All patients should be offered clinical trial participation when feasible, a strong recommendation based on high-quality evidence.

To assess the response to therapy, R-CHOP and ISRT recipients not participating in a clinical trial should receive a PET-CT scan 2-3 months after treatment is completed, and DA-EPOCH-R patients should receive their scan 6 weeks after the end of therapy. For all patients, Deauville criteria should be used in reporting response scan results. These strong recommendations about posttherapy imaging are based on moderate-quality evidence.

The rate of relapse and refractory disease is relatively low at about 10%-30%, Dr. Cwynarski and her colleagues said. Relapse usually happens within the first year and is rare after 2 years; extranodal disease is common, but usually spares the central nervous system and bone marrow. The good practice paper authors strongly recommend, based on high-quality evidence, that biopsy and fluorodeoxyglucose-PET/CT should be performed with relapse.

Radiotherapy can be considered if the relapse is localized and the patient didn’t receive initial radiotherapy, a strong recommendation with moderate evidence to support it.

Salvage regimens for patients who have not previously achieved complete metabolic response lack a disease-specific evidence base, noted Dr. Cwynarski and her colleagues. Taking this into consideration, a PMBCL salvage regimen should be the same as that offered to patients with relapsed diffused large B-cell lymphoma. High-dose therapy and autologous stem cell transplantation is appropriate for responsive disease.

If radiotherapy had not been given previously, it should be considered either pre- or post transplant. This, along with the other salvage therapy guidance, is a weak recommendation, backed by moderate evidence.

For longer-term follow-up, asymptomatic patients should not have routine imaging, a strong recommendation with moderate evidence. “[P]atients who remain in remission may be considered for discharge back to primary care,” Dr. Cwynarski and her coauthors said, making a weak recommendation based on low-quality evidence. Patients and their primary care providers should know about the potential for such long-term complications as cardiac toxicities and second malignancies.

[email protected]

SOURCE: Cwynarski K et al. Br J Haematol. 2019 Jan 4. doi:10.1111/bjh.15731

Fertility preservation, imaging and radiotherapy guidelines, and best practices in relapse or salvage therapy for primary mediastinal B-cell lymphoma (PMBCL) are all highlighted in a new good practice paper from the British Society for Haematology.

Though PMBCL was previously thought of as a subtype of diffuse large B-cell lymphoma, “gene expression profiling data has shown it to be a separate clinicopathological entity with evidence of an overlap with classic Hodgkin lymphoma,” said Kate Cwynarski, MD, PhD, of University College London Hospitals NHS Foundation Trust in England, and her coauthors. The recommendations were published in the British Journal of Haematology.

PMBCL makes up 2%-4% of non-Hodgkin lymphomas, they said; a bulky anterior mediastinal mass is the usual initial presentation. PMBCL does not usually spread beyond the thoracic cavity.

Biopsy, which should be reviewed by a hematopathologist, is required for a histological diagnosis of PMBCL. A multidisciplinary team should review the clinical presentation, pathology, and management plan, according to the good practice paper authors. This was a strong recommendation backed by a high level of evidence.

In addition, patients should receive positron emission tomography–computed tomography (PET/CT) at diagnosis, before steroids are administered, if possible, as standard of care. Results from the PET/CT should be reported in accordance with international guidelines. These strong recommendations are backed by high-quality evidence.

If PET/CT is performed, then “a bone marrow biopsy is not considered essential,” said Dr. Cwynarski and her coauthors. However, if the findings would influence management, such as when there is extranodal disease that presents central nervous system opportunities, then bone marrow biopsy should be performed. It should also be performed when cytotoxic therapy was initiated before PET/CT could be done. This is a weak recommendation supported by moderate evidence.

Since patients with PMBCL are usually young adults at presentation, it’s important to consider fertility preservation in the face of chemotherapy. For males, semen preservation should be offered. Female patients may not be able to postpone treatment long enough to accomplish egg harvesting. The risk of infertility and premature ovarian failure will depend on the treatment regimen, so “the risks of each individual therapeutic regimen should be discussed with the patient,” Dr. Cwynarski and her colleagues said.

If a patient is diagnosed with PMBCL while pregnant, treatment should be managed in conjunction with high-risk obstetrics and anesthesia specialists. Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) has been used in pregnancy, and immunotherapy without antimetabolites can be considered in the second and third trimesters, according to the good practice paper. These are strong fertility and pregnancy recommendations, backed by moderate to low-quality evidence.

If superior vena cava obstruction causes thrombosis, local standard of care for anticoagulation should be used, but therapy-induced thrombocytopenia should be taken into consideration.

There is a lack of prospective, randomized studies to guide treatment decisions in PMBCL, according to the paper. Still, adding rituximab improves both response rates and duration of remission, they noted.

The standard of care for treatment is six cycles of R-CHOP and involved site radiotherapy (ISRT). If the patient is being cared for at a site that can manage the complexities of dose adjustment and monitoring, dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) without ISRT is an alternative, according to the good practice paper.

All patients should be offered clinical trial participation when feasible, a strong recommendation based on high-quality evidence.

To assess the response to therapy, R-CHOP and ISRT recipients not participating in a clinical trial should receive a PET-CT scan 2-3 months after treatment is completed, and DA-EPOCH-R patients should receive their scan 6 weeks after the end of therapy. For all patients, Deauville criteria should be used in reporting response scan results. These strong recommendations about posttherapy imaging are based on moderate-quality evidence.

The rate of relapse and refractory disease is relatively low at about 10%-30%, Dr. Cwynarski and her colleagues said. Relapse usually happens within the first year and is rare after 2 years; extranodal disease is common, but usually spares the central nervous system and bone marrow. The good practice paper authors strongly recommend, based on high-quality evidence, that biopsy and fluorodeoxyglucose-PET/CT should be performed with relapse.

Radiotherapy can be considered if the relapse is localized and the patient didn’t receive initial radiotherapy, a strong recommendation with moderate evidence to support it.

Salvage regimens for patients who have not previously achieved complete metabolic response lack a disease-specific evidence base, noted Dr. Cwynarski and her colleagues. Taking this into consideration, a PMBCL salvage regimen should be the same as that offered to patients with relapsed diffused large B-cell lymphoma. High-dose therapy and autologous stem cell transplantation is appropriate for responsive disease.

If radiotherapy had not been given previously, it should be considered either pre- or post transplant. This, along with the other salvage therapy guidance, is a weak recommendation, backed by moderate evidence.

For longer-term follow-up, asymptomatic patients should not have routine imaging, a strong recommendation with moderate evidence. “[P]atients who remain in remission may be considered for discharge back to primary care,” Dr. Cwynarski and her coauthors said, making a weak recommendation based on low-quality evidence. Patients and their primary care providers should know about the potential for such long-term complications as cardiac toxicities and second malignancies.

[email protected]

SOURCE: Cwynarski K et al. Br J Haematol. 2019 Jan 4. doi:10.1111/bjh.15731

Fertility preservation, imaging and radiotherapy guidelines, and best practices in relapse or salvage therapy for primary mediastinal B-cell lymphoma (PMBCL) are all highlighted in a new good practice paper from the British Society for Haematology.

Though PMBCL was previously thought of as a subtype of diffuse large B-cell lymphoma, “gene expression profiling data has shown it to be a separate clinicopathological entity with evidence of an overlap with classic Hodgkin lymphoma,” said Kate Cwynarski, MD, PhD, of University College London Hospitals NHS Foundation Trust in England, and her coauthors. The recommendations were published in the British Journal of Haematology.

PMBCL makes up 2%-4% of non-Hodgkin lymphomas, they said; a bulky anterior mediastinal mass is the usual initial presentation. PMBCL does not usually spread beyond the thoracic cavity.

Biopsy, which should be reviewed by a hematopathologist, is required for a histological diagnosis of PMBCL. A multidisciplinary team should review the clinical presentation, pathology, and management plan, according to the good practice paper authors. This was a strong recommendation backed by a high level of evidence.

In addition, patients should receive positron emission tomography–computed tomography (PET/CT) at diagnosis, before steroids are administered, if possible, as standard of care. Results from the PET/CT should be reported in accordance with international guidelines. These strong recommendations are backed by high-quality evidence.

If PET/CT is performed, then “a bone marrow biopsy is not considered essential,” said Dr. Cwynarski and her coauthors. However, if the findings would influence management, such as when there is extranodal disease that presents central nervous system opportunities, then bone marrow biopsy should be performed. It should also be performed when cytotoxic therapy was initiated before PET/CT could be done. This is a weak recommendation supported by moderate evidence.

Since patients with PMBCL are usually young adults at presentation, it’s important to consider fertility preservation in the face of chemotherapy. For males, semen preservation should be offered. Female patients may not be able to postpone treatment long enough to accomplish egg harvesting. The risk of infertility and premature ovarian failure will depend on the treatment regimen, so “the risks of each individual therapeutic regimen should be discussed with the patient,” Dr. Cwynarski and her colleagues said.

If a patient is diagnosed with PMBCL while pregnant, treatment should be managed in conjunction with high-risk obstetrics and anesthesia specialists. Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) has been used in pregnancy, and immunotherapy without antimetabolites can be considered in the second and third trimesters, according to the good practice paper. These are strong fertility and pregnancy recommendations, backed by moderate to low-quality evidence.

If superior vena cava obstruction causes thrombosis, local standard of care for anticoagulation should be used, but therapy-induced thrombocytopenia should be taken into consideration.

There is a lack of prospective, randomized studies to guide treatment decisions in PMBCL, according to the paper. Still, adding rituximab improves both response rates and duration of remission, they noted.

The standard of care for treatment is six cycles of R-CHOP and involved site radiotherapy (ISRT). If the patient is being cared for at a site that can manage the complexities of dose adjustment and monitoring, dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) without ISRT is an alternative, according to the good practice paper.

All patients should be offered clinical trial participation when feasible, a strong recommendation based on high-quality evidence.

To assess the response to therapy, R-CHOP and ISRT recipients not participating in a clinical trial should receive a PET-CT scan 2-3 months after treatment is completed, and DA-EPOCH-R patients should receive their scan 6 weeks after the end of therapy. For all patients, Deauville criteria should be used in reporting response scan results. These strong recommendations about posttherapy imaging are based on moderate-quality evidence.

The rate of relapse and refractory disease is relatively low at about 10%-30%, Dr. Cwynarski and her colleagues said. Relapse usually happens within the first year and is rare after 2 years; extranodal disease is common, but usually spares the central nervous system and bone marrow. The good practice paper authors strongly recommend, based on high-quality evidence, that biopsy and fluorodeoxyglucose-PET/CT should be performed with relapse.

Radiotherapy can be considered if the relapse is localized and the patient didn’t receive initial radiotherapy, a strong recommendation with moderate evidence to support it.

Salvage regimens for patients who have not previously achieved complete metabolic response lack a disease-specific evidence base, noted Dr. Cwynarski and her colleagues. Taking this into consideration, a PMBCL salvage regimen should be the same as that offered to patients with relapsed diffused large B-cell lymphoma. High-dose therapy and autologous stem cell transplantation is appropriate for responsive disease.

If radiotherapy had not been given previously, it should be considered either pre- or post transplant. This, along with the other salvage therapy guidance, is a weak recommendation, backed by moderate evidence.

For longer-term follow-up, asymptomatic patients should not have routine imaging, a strong recommendation with moderate evidence. “[P]atients who remain in remission may be considered for discharge back to primary care,” Dr. Cwynarski and her coauthors said, making a weak recommendation based on low-quality evidence. Patients and their primary care providers should know about the potential for such long-term complications as cardiac toxicities and second malignancies.

[email protected]

SOURCE: Cwynarski K et al. Br J Haematol. 2019 Jan 4. doi:10.1111/bjh.15731

GRAND CAYMAN, CAYMAN ISLANDS – Large doses of nonsedating second-generation antihistamines are at the heart of treating chronic urticaria and will adequately control symptoms in about half of patients.

Michele G. Sullivan/MDEdge News

But for those who don’t respond, treatment guidelines in both the United States and Europe outline a stepwise algorithm that should eventually control symptoms in about 95% of people, without continuous steroid use, Diane Baker, MD, said at the Caribbean Dermatology Symposium, provided by Global Academy for Medical Education.

The guidelines from the American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma, and Immunology, and the European Academy of Allergy and Clinical Immunology [EAACI] and the American Academy of Allergy /Global Allergy are markedly similar, said Dr. Baker, a dermatologist in Portland, Ore.

The U.S. document offers a few more choices in its algorithm, while the European document sticks to a more straightforward progression of antihistamine progressing to omalizumab and then to cyclosporine.

“Both guidelines start with monotherapy of a second-generation antihistamine in the licensed dose. This has to be continuous monotherapy though. We still get patients who say, ‘My hives get better with the antihistamine, but they come back when I’m not taking it.’ Yes, patients need to understand that they have to stay on daily doses in order to control symptoms.”

Drug choice is largely physician preference. A 2014 Cochrane review examined 73 studies of H1-histamine blockers in 9,759 participants and found little difference between any of the drugs. “No single H1‐antihistamine stands out as most effective,” the authors concluded. “Cetirizine at 10 mg once daily in the short term and in the intermediate term was found to be effective in completely suppressing urticaria. Evidence is limited for desloratadine given at 5 mg once daily in the intermediate term and at 20 mg in the short term. Levocetirizine at 5 mg in the intermediate but not short term was effective for complete suppression. Levocetirizine 20 mg was effective in the short term, but 10 mg was not,” the study noted (Cochrane Database Syst Rev. 2014 Nov 14;[11]:CD006137).

“In my practice, we use cetirizine,” Dr. Baker said. “But if a patient is on fexofenadine, for example, and doing well, I wouldn’t change that.”

The treatment guidelines agree on the next step for unresponsive patients: Updosing the antihistamine. “You may have to jump up to four times the recommended dose,” she said. “Sometimes we do this gradually, but sometimes I go right ahead to that dose just to get the patient under control. And there’s good evidence that 50%-75% of our patients will be controlled on an updosing regimen. Just keep them on it until they are symptom free, and then you can try reducing it to see how they do.”

But even this can leave up to half of patients still itching. The next treatment step is where the guidelines diverge, Dr. Baker said. The U.S. document suggests trying several other options, including adding another second-generation antihistamine, adding an H2 agonist, a leukotriene receptor antagonist, or a sedating first-generation antihistamine.

“The European recommendation is to go straight to omalizumab,” Dr. Baker said. “They based this recommendation on the finding of insufficient evidence in the literature for any of these other things.”

Instead of recommending omalizumab to antihistamine-resistant patients, the U.S. guidelines suggest a dose-advancement trial of hydroxyzine or doxepin.

But there’s no arguing that omalizumab is highly effective for chronic urticaria, Dr. Baker noted. The 2015 ASTERIA trial perfectly illustrated the drug’s benefit for patients who were still symptomatic on optimal antihistamine treatment (J Invest Dermatol. 2015 Jan;135[1]:67-75).

The 40-week, randomized, double-blind placebo controlled study enrolled 319 patients, who received the injections as a monthly add-on therapy for 24 weeks in doses of 75 mg, 150 mg, or 300 mg or placebo. This was followed by 16 weeks of observation. The primary endpoint was change from baseline in weekly Itch Severity Score (ISS) at week 12.

The omalizumab 300-mg group had the best ISS scores at the end of the study. This group also met nine secondary endpoints, including a decreased time to reach the clinically important response of at least a 5-point ISS decrease.

The drug carries a low risk of adverse events, with just four patients (5%) in the omalizumab 300-mg group developing a serious side effect; none of these were judged to be related to the study drug. There is a very low risk of anaphylaxis associated with omalizumab – about 0.1% in clinical trials and 0.2% in postmarketing observational studies. A 2017 review of three omalizumab studies determined that asthma is the biggest risk factor for such a reaction.

The review found 132 patients with potential anaphylaxis associated with omalizumab. Asthma was the indication for omalizumab therapy in 80%; 43% of patients who provided an anaphylaxis history said that they had experienced a prior non–omalizumab-related reaction.

The U.S. guidelines don’t bring omalizumab into the picture until the final step, which recommends it, cyclosporine, or other unspecified biologics or immunosuppressive agents. At this point, however, the European guidelines move to a cyclosporine recommendation for the very small number of patients who were unresponsive to omalizumab.

Pivotal trials of omalizumab in urticaria used a once-monthly injection schedule, but more recent data suggest that patients who get the drug every 2 weeks may do better, Dr. Baker added. A chart review published in 2016 found a 100% response rate in patients who received twice monthly doses of 300 mg (J Am Acad Dermatol. 2016 Jun;74[6]:1274-6).

Dr. Baker disclosed that she has been a clinical trial investigator for Novartis.

Global Academy and this news organization are owned by the same parent company.

This article was updated 2/1/19.

[email protected]

GRAND CAYMAN, CAYMAN ISLANDS – Large doses of nonsedating second-generation antihistamines are at the heart of treating chronic urticaria and will adequately control symptoms in about half of patients.

Michele G. Sullivan/MDEdge News

But for those who don’t respond, treatment guidelines in both the United States and Europe outline a stepwise algorithm that should eventually control symptoms in about 95% of people, without continuous steroid use, Diane Baker, MD, said at the Caribbean Dermatology Symposium, provided by Global Academy for Medical Education.

The guidelines from the American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma, and Immunology, and the European Academy of Allergy and Clinical Immunology [EAACI] and the American Academy of Allergy /Global Allergy are markedly similar, said Dr. Baker, a dermatologist in Portland, Ore.

The U.S. document offers a few more choices in its algorithm, while the European document sticks to a more straightforward progression of antihistamine progressing to omalizumab and then to cyclosporine.

“Both guidelines start with monotherapy of a second-generation antihistamine in the licensed dose. This has to be continuous monotherapy though. We still get patients who say, ‘My hives get better with the antihistamine, but they come back when I’m not taking it.’ Yes, patients need to understand that they have to stay on daily doses in order to control symptoms.”

Drug choice is largely physician preference. A 2014 Cochrane review examined 73 studies of H1-histamine blockers in 9,759 participants and found little difference between any of the drugs. “No single H1‐antihistamine stands out as most effective,” the authors concluded. “Cetirizine at 10 mg once daily in the short term and in the intermediate term was found to be effective in completely suppressing urticaria. Evidence is limited for desloratadine given at 5 mg once daily in the intermediate term and at 20 mg in the short term. Levocetirizine at 5 mg in the intermediate but not short term was effective for complete suppression. Levocetirizine 20 mg was effective in the short term, but 10 mg was not,” the study noted (Cochrane Database Syst Rev. 2014 Nov 14;[11]:CD006137).

“In my practice, we use cetirizine,” Dr. Baker said. “But if a patient is on fexofenadine, for example, and doing well, I wouldn’t change that.”

The treatment guidelines agree on the next step for unresponsive patients: Updosing the antihistamine. “You may have to jump up to four times the recommended dose,” she said. “Sometimes we do this gradually, but sometimes I go right ahead to that dose just to get the patient under control. And there’s good evidence that 50%-75% of our patients will be controlled on an updosing regimen. Just keep them on it until they are symptom free, and then you can try reducing it to see how they do.”

But even this can leave up to half of patients still itching. The next treatment step is where the guidelines diverge, Dr. Baker said. The U.S. document suggests trying several other options, including adding another second-generation antihistamine, adding an H2 agonist, a leukotriene receptor antagonist, or a sedating first-generation antihistamine.

“The European recommendation is to go straight to omalizumab,” Dr. Baker said. “They based this recommendation on the finding of insufficient evidence in the literature for any of these other things.”

Instead of recommending omalizumab to antihistamine-resistant patients, the U.S. guidelines suggest a dose-advancement trial of hydroxyzine or doxepin.

But there’s no arguing that omalizumab is highly effective for chronic urticaria, Dr. Baker noted. The 2015 ASTERIA trial perfectly illustrated the drug’s benefit for patients who were still symptomatic on optimal antihistamine treatment (J Invest Dermatol. 2015 Jan;135[1]:67-75).

The 40-week, randomized, double-blind placebo controlled study enrolled 319 patients, who received the injections as a monthly add-on therapy for 24 weeks in doses of 75 mg, 150 mg, or 300 mg or placebo. This was followed by 16 weeks of observation. The primary endpoint was change from baseline in weekly Itch Severity Score (ISS) at week 12.

The omalizumab 300-mg group had the best ISS scores at the end of the study. This group also met nine secondary endpoints, including a decreased time to reach the clinically important response of at least a 5-point ISS decrease.

The drug carries a low risk of adverse events, with just four patients (5%) in the omalizumab 300-mg group developing a serious side effect; none of these were judged to be related to the study drug. There is a very low risk of anaphylaxis associated with omalizumab – about 0.1% in clinical trials and 0.2% in postmarketing observational studies. A 2017 review of three omalizumab studies determined that asthma is the biggest risk factor for such a reaction.

The review found 132 patients with potential anaphylaxis associated with omalizumab. Asthma was the indication for omalizumab therapy in 80%; 43% of patients who provided an anaphylaxis history said that they had experienced a prior non–omalizumab-related reaction.

The U.S. guidelines don’t bring omalizumab into the picture until the final step, which recommends it, cyclosporine, or other unspecified biologics or immunosuppressive agents. At this point, however, the European guidelines move to a cyclosporine recommendation for the very small number of patients who were unresponsive to omalizumab.

Pivotal trials of omalizumab in urticaria used a once-monthly injection schedule, but more recent data suggest that patients who get the drug every 2 weeks may do better, Dr. Baker added. A chart review published in 2016 found a 100% response rate in patients who received twice monthly doses of 300 mg (J Am Acad Dermatol. 2016 Jun;74[6]:1274-6).

Dr. Baker disclosed that she has been a clinical trial investigator for Novartis.

Global Academy and this news organization are owned by the same parent company.

This article was updated 2/1/19.

[email protected]

GRAND CAYMAN, CAYMAN ISLANDS – Large doses of nonsedating second-generation antihistamines are at the heart of treating chronic urticaria and will adequately control symptoms in about half of patients.

Michele G. Sullivan/MDEdge News

But for those who don’t respond, treatment guidelines in both the United States and Europe outline a stepwise algorithm that should eventually control symptoms in about 95% of people, without continuous steroid use, Diane Baker, MD, said at the Caribbean Dermatology Symposium, provided by Global Academy for Medical Education.

The guidelines from the American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma, and Immunology, and the European Academy of Allergy and Clinical Immunology [EAACI] and the American Academy of Allergy /Global Allergy are markedly similar, said Dr. Baker, a dermatologist in Portland, Ore.

The U.S. document offers a few more choices in its algorithm, while the European document sticks to a more straightforward progression of antihistamine progressing to omalizumab and then to cyclosporine.

“Both guidelines start with monotherapy of a second-generation antihistamine in the licensed dose. This has to be continuous monotherapy though. We still get patients who say, ‘My hives get better with the antihistamine, but they come back when I’m not taking it.’ Yes, patients need to understand that they have to stay on daily doses in order to control symptoms.”

Drug choice is largely physician preference. A 2014 Cochrane review examined 73 studies of H1-histamine blockers in 9,759 participants and found little difference between any of the drugs. “No single H1‐antihistamine stands out as most effective,” the authors concluded. “Cetirizine at 10 mg once daily in the short term and in the intermediate term was found to be effective in completely suppressing urticaria. Evidence is limited for desloratadine given at 5 mg once daily in the intermediate term and at 20 mg in the short term. Levocetirizine at 5 mg in the intermediate but not short term was effective for complete suppression. Levocetirizine 20 mg was effective in the short term, but 10 mg was not,” the study noted (Cochrane Database Syst Rev. 2014 Nov 14;[11]:CD006137).

“In my practice, we use cetirizine,” Dr. Baker said. “But if a patient is on fexofenadine, for example, and doing well, I wouldn’t change that.”

The treatment guidelines agree on the next step for unresponsive patients: Updosing the antihistamine. “You may have to jump up to four times the recommended dose,” she said. “Sometimes we do this gradually, but sometimes I go right ahead to that dose just to get the patient under control. And there’s good evidence that 50%-75% of our patients will be controlled on an updosing regimen. Just keep them on it until they are symptom free, and then you can try reducing it to see how they do.”

But even this can leave up to half of patients still itching. The next treatment step is where the guidelines diverge, Dr. Baker said. The U.S. document suggests trying several other options, including adding another second-generation antihistamine, adding an H2 agonist, a leukotriene receptor antagonist, or a sedating first-generation antihistamine.

“The European recommendation is to go straight to omalizumab,” Dr. Baker said. “They based this recommendation on the finding of insufficient evidence in the literature for any of these other things.”

Instead of recommending omalizumab to antihistamine-resistant patients, the U.S. guidelines suggest a dose-advancement trial of hydroxyzine or doxepin.

But there’s no arguing that omalizumab is highly effective for chronic urticaria, Dr. Baker noted. The 2015 ASTERIA trial perfectly illustrated the drug’s benefit for patients who were still symptomatic on optimal antihistamine treatment (J Invest Dermatol. 2015 Jan;135[1]:67-75).

The 40-week, randomized, double-blind placebo controlled study enrolled 319 patients, who received the injections as a monthly add-on therapy for 24 weeks in doses of 75 mg, 150 mg, or 300 mg or placebo. This was followed by 16 weeks of observation. The primary endpoint was change from baseline in weekly Itch Severity Score (ISS) at week 12.

The omalizumab 300-mg group had the best ISS scores at the end of the study. This group also met nine secondary endpoints, including a decreased time to reach the clinically important response of at least a 5-point ISS decrease.

The drug carries a low risk of adverse events, with just four patients (5%) in the omalizumab 300-mg group developing a serious side effect; none of these were judged to be related to the study drug. There is a very low risk of anaphylaxis associated with omalizumab – about 0.1% in clinical trials and 0.2% in postmarketing observational studies. A 2017 review of three omalizumab studies determined that asthma is the biggest risk factor for such a reaction.

The review found 132 patients with potential anaphylaxis associated with omalizumab. Asthma was the indication for omalizumab therapy in 80%; 43% of patients who provided an anaphylaxis history said that they had experienced a prior non–omalizumab-related reaction.

The U.S. guidelines don’t bring omalizumab into the picture until the final step, which recommends it, cyclosporine, or other unspecified biologics or immunosuppressive agents. At this point, however, the European guidelines move to a cyclosporine recommendation for the very small number of patients who were unresponsive to omalizumab.

Pivotal trials of omalizumab in urticaria used a once-monthly injection schedule, but more recent data suggest that patients who get the drug every 2 weeks may do better, Dr. Baker added. A chart review published in 2016 found a 100% response rate in patients who received twice monthly doses of 300 mg (J Am Acad Dermatol. 2016 Jun;74[6]:1274-6).

Dr. Baker disclosed that she has been a clinical trial investigator for Novartis.

Global Academy and this news organization are owned by the same parent company.

This article was updated 2/1/19.

[email protected]

Ob.gyns. will need to focus more on individualized care as they use the two new practice bulletins, one on chronic hypertension in pregnancy and one on gestational hypertension and preeclampsia, released by the American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Obstetrics.

Jupiterimages/Thinkstock.com

The bulletins will replace the 2013 ACOG hypertension in pregnancy task force report and are published in the January issue of Obstetrics & Gynecology.

“The task force was a tour de force in creating a comprehensive view of hypertensive diseases of pregnancy, including research,” Christian M. Pettker, MD, who helped develop both practice bulletins, stated in a press release. “The updated guidance provides clearer recommendations for the management of gestational hypertension with severe-range blood pressure, an emphasis on and instructions for timely treatment of acutely elevated blood pressures, and more defined recommendations for the management of pain in postoperative patients with hypertension.”

“Ob.gyns. will need to focus more on individualized care and may find it’s best to err on the side of caution because the appropriate treatment of hypertensive diseases in pregnancy may be the most important focus of our attempts to improve maternal mortality and morbidity in the United States,” he said.*
 

Gestational hypertension or preeclampsia

For women with gestational hypertension or preeclampsia at 37 weeks of gestation or later without severe features, the guidelines recommend delivery rather than expectant management.

Those patients with severe features of gestational hypertension or preeclampsia or eclampsia should receive magnesium sulfate to prevent or treat seizures.

Patients should receive low-dose aspirin (81 mg/day) for preeclampsia prophylaxis between 12 weeks and 28 weeks of gestation if they have high-risk factors of preeclampsia such as multifetal gestation, a previous pregnancy with preeclampsia, renal disease, autoimmune disease, type 1 or type 2 diabetes mellitus, chronic hypertension, or a previous pregnancy with preeclampsia; or more than one moderate risk factor such as a family history of preeclampsia, maternal age greater than 35 years, first pregnancy, body mass index greater than 30, personal history factors, or sociodemographic characteristics.

NSAIDs should continue to be used in preference to opioid analgesics.

The guidance also discusses mode of delivery, antihypertensive drugs and thresholds for treatment, management of acute complications for preeclampsia with HELLP (hemolysis, elevated liver enzymes, low platelet count) syndrome, the optimal treatment for eclampsia, and postpartum hypertension and headache.
 

Chronic hypertension

Pregnant women with chronic hypertension also should receive low-dose aspirin between 12 weeks and 28 weeks of gestation. Antihypertensive therapy should be initiated for women with persistent chronic hypertension at systolic pressure of 160 mm Hg or higher and/or diastolic pressure of 110 mm Hg or higher. Consider treating patients at lower blood pressure (BP) thresholds depending on comorbidities or underlying impaired renal function.

ACOG has recommended treating pregnant patients as chronically hypertensive according to recently changed criteria from the American College of Cardiology and the American Heart Association, which call for classifying blood pressure into the following categories:

• Normal. Systolic BP less than 120 mm Hg; diastolic BP less than 80 mm Hg.
• Elevated. Systolic BP greater than or equal to 120-129 mm Hg; diastolic BP greater than 80 mm Hg.
• Stage 1 hypertension. Systolic BP, 130-139 mm Hg; diastolic BP, 80-89 mm Hg.
• Stage 2 hypertension. Systolic BP greater than or equal to 140 mm Hg; diastolic BP greater than or equal to 90 mm Hg.

“The new blood pressure ranges for nonpregnant women have a lower threshold for hypertension diagnosis compared to ACOG’s criteria,” Dr. Pettker said. “This will likely cause a general increase in patients classified as chronic hypertensive and will require shared decision making by the ob.gyn. and the patient regarding appropriate management in pregnancy.”

The guideline also discusses chronic hypertension with superimposed preeclampsia; tests for baseline evaluation of chronic hypertension in pregnancy; common oral antihypertensive agents to use in pregnancy and those to use for urgent blood pressure control in pregnancy; control of acute-onset severe-range hypertension; and postpartum considerations in patients with chronic hypertension.

SOURCE: Gestational hypertension and preeclampsia. ACOG Practice Bulletin No. 202. Obstet Gynecol. 2019;133:e1-25; Chronic hypertension in pregnancy. ACOG Practice Bulletin No. 203. Obstet Gynecol. 2019;133:e26-50.

This article was updated 1/11/19 and 11/19/19.

Ob.gyns. will need to focus more on individualized care as they use the two new practice bulletins, one on chronic hypertension in pregnancy and one on gestational hypertension and preeclampsia, released by the American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Obstetrics.

Jupiterimages/Thinkstock.com

The bulletins will replace the 2013 ACOG hypertension in pregnancy task force report and are published in the January issue of Obstetrics & Gynecology.

“The task force was a tour de force in creating a comprehensive view of hypertensive diseases of pregnancy, including research,” Christian M. Pettker, MD, who helped develop both practice bulletins, stated in a press release. “The updated guidance provides clearer recommendations for the management of gestational hypertension with severe-range blood pressure, an emphasis on and instructions for timely treatment of acutely elevated blood pressures, and more defined recommendations for the management of pain in postoperative patients with hypertension.”

“Ob.gyns. will need to focus more on individualized care and may find it’s best to err on the side of caution because the appropriate treatment of hypertensive diseases in pregnancy may be the most important focus of our attempts to improve maternal mortality and morbidity in the United States,” he said.*
 

Gestational hypertension or preeclampsia

For women with gestational hypertension or preeclampsia at 37 weeks of gestation or later without severe features, the guidelines recommend delivery rather than expectant management.

Those patients with severe features of gestational hypertension or preeclampsia or eclampsia should receive magnesium sulfate to prevent or treat seizures.

Patients should receive low-dose aspirin (81 mg/day) for preeclampsia prophylaxis between 12 weeks and 28 weeks of gestation if they have high-risk factors of preeclampsia such as multifetal gestation, a previous pregnancy with preeclampsia, renal disease, autoimmune disease, type 1 or type 2 diabetes mellitus, chronic hypertension, or a previous pregnancy with preeclampsia; or more than one moderate risk factor such as a family history of preeclampsia, maternal age greater than 35 years, first pregnancy, body mass index greater than 30, personal history factors, or sociodemographic characteristics.

NSAIDs should continue to be used in preference to opioid analgesics.

The guidance also discusses mode of delivery, antihypertensive drugs and thresholds for treatment, management of acute complications for preeclampsia with HELLP (hemolysis, elevated liver enzymes, low platelet count) syndrome, the optimal treatment for eclampsia, and postpartum hypertension and headache.
 

Chronic hypertension

Pregnant women with chronic hypertension also should receive low-dose aspirin between 12 weeks and 28 weeks of gestation. Antihypertensive therapy should be initiated for women with persistent chronic hypertension at systolic pressure of 160 mm Hg or higher and/or diastolic pressure of 110 mm Hg or higher. Consider treating patients at lower blood pressure (BP) thresholds depending on comorbidities or underlying impaired renal function.

ACOG has recommended treating pregnant patients as chronically hypertensive according to recently changed criteria from the American College of Cardiology and the American Heart Association, which call for classifying blood pressure into the following categories:

• Normal. Systolic BP less than 120 mm Hg; diastolic BP less than 80 mm Hg.
• Elevated. Systolic BP greater than or equal to 120-129 mm Hg; diastolic BP greater than 80 mm Hg.
• Stage 1 hypertension. Systolic BP, 130-139 mm Hg; diastolic BP, 80-89 mm Hg.
• Stage 2 hypertension. Systolic BP greater than or equal to 140 mm Hg; diastolic BP greater than or equal to 90 mm Hg.

“The new blood pressure ranges for nonpregnant women have a lower threshold for hypertension diagnosis compared to ACOG’s criteria,” Dr. Pettker said. “This will likely cause a general increase in patients classified as chronic hypertensive and will require shared decision making by the ob.gyn. and the patient regarding appropriate management in pregnancy.”

The guideline also discusses chronic hypertension with superimposed preeclampsia; tests for baseline evaluation of chronic hypertension in pregnancy; common oral antihypertensive agents to use in pregnancy and those to use for urgent blood pressure control in pregnancy; control of acute-onset severe-range hypertension; and postpartum considerations in patients with chronic hypertension.

SOURCE: Gestational hypertension and preeclampsia. ACOG Practice Bulletin No. 202. Obstet Gynecol. 2019;133:e1-25; Chronic hypertension in pregnancy. ACOG Practice Bulletin No. 203. Obstet Gynecol. 2019;133:e26-50.

This article was updated 1/11/19 and 11/19/19.

Ob.gyns. will need to focus more on individualized care as they use the two new practice bulletins, one on chronic hypertension in pregnancy and one on gestational hypertension and preeclampsia, released by the American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Obstetrics.

Jupiterimages/Thinkstock.com

The bulletins will replace the 2013 ACOG hypertension in pregnancy task force report and are published in the January issue of Obstetrics & Gynecology.

“The task force was a tour de force in creating a comprehensive view of hypertensive diseases of pregnancy, including research,” Christian M. Pettker, MD, who helped develop both practice bulletins, stated in a press release. “The updated guidance provides clearer recommendations for the management of gestational hypertension with severe-range blood pressure, an emphasis on and instructions for timely treatment of acutely elevated blood pressures, and more defined recommendations for the management of pain in postoperative patients with hypertension.”

“Ob.gyns. will need to focus more on individualized care and may find it’s best to err on the side of caution because the appropriate treatment of hypertensive diseases in pregnancy may be the most important focus of our attempts to improve maternal mortality and morbidity in the United States,” he said.*
 

Gestational hypertension or preeclampsia

For women with gestational hypertension or preeclampsia at 37 weeks of gestation or later without severe features, the guidelines recommend delivery rather than expectant management.

Those patients with severe features of gestational hypertension or preeclampsia or eclampsia should receive magnesium sulfate to prevent or treat seizures.

Patients should receive low-dose aspirin (81 mg/day) for preeclampsia prophylaxis between 12 weeks and 28 weeks of gestation if they have high-risk factors of preeclampsia such as multifetal gestation, a previous pregnancy with preeclampsia, renal disease, autoimmune disease, type 1 or type 2 diabetes mellitus, chronic hypertension, or a previous pregnancy with preeclampsia; or more than one moderate risk factor such as a family history of preeclampsia, maternal age greater than 35 years, first pregnancy, body mass index greater than 30, personal history factors, or sociodemographic characteristics.

NSAIDs should continue to be used in preference to opioid analgesics.

The guidance also discusses mode of delivery, antihypertensive drugs and thresholds for treatment, management of acute complications for preeclampsia with HELLP (hemolysis, elevated liver enzymes, low platelet count) syndrome, the optimal treatment for eclampsia, and postpartum hypertension and headache.
 

Chronic hypertension

Pregnant women with chronic hypertension also should receive low-dose aspirin between 12 weeks and 28 weeks of gestation. Antihypertensive therapy should be initiated for women with persistent chronic hypertension at systolic pressure of 160 mm Hg or higher and/or diastolic pressure of 110 mm Hg or higher. Consider treating patients at lower blood pressure (BP) thresholds depending on comorbidities or underlying impaired renal function.

ACOG has recommended treating pregnant patients as chronically hypertensive according to recently changed criteria from the American College of Cardiology and the American Heart Association, which call for classifying blood pressure into the following categories:

• Normal. Systolic BP less than 120 mm Hg; diastolic BP less than 80 mm Hg.
• Elevated. Systolic BP greater than or equal to 120-129 mm Hg; diastolic BP greater than 80 mm Hg.
• Stage 1 hypertension. Systolic BP, 130-139 mm Hg; diastolic BP, 80-89 mm Hg.
• Stage 2 hypertension. Systolic BP greater than or equal to 140 mm Hg; diastolic BP greater than or equal to 90 mm Hg.

“The new blood pressure ranges for nonpregnant women have a lower threshold for hypertension diagnosis compared to ACOG’s criteria,” Dr. Pettker said. “This will likely cause a general increase in patients classified as chronic hypertensive and will require shared decision making by the ob.gyn. and the patient regarding appropriate management in pregnancy.”

The guideline also discusses chronic hypertension with superimposed preeclampsia; tests for baseline evaluation of chronic hypertension in pregnancy; common oral antihypertensive agents to use in pregnancy and those to use for urgent blood pressure control in pregnancy; control of acute-onset severe-range hypertension; and postpartum considerations in patients with chronic hypertension.

SOURCE: Gestational hypertension and preeclampsia. ACOG Practice Bulletin No. 202. Obstet Gynecol. 2019;133:e1-25; Chronic hypertension in pregnancy. ACOG Practice Bulletin No. 203. Obstet Gynecol. 2019;133:e26-50.

This article was updated 1/11/19 and 11/19/19.

A new clinical practice update recommends combination therapy with tumor necrosis factor (TNF) inhibitors and thiopurines, as opposed to either therapy alone, for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD). The commentary was published in Gastroenterology.

Clinicians should also note that while several clinical trials use weight-based dosing to monitor clinical response following thiopurine therapy, 6-thioguanine levels have inevitably shown to better predict prognosis, wrote Stephen B. Hanauer, MD, AGAF, of Northwestern University in Chicago and his colleagues.

The thiopurine drug class is composed of many different agents, including thioguanine, azathioprine, and mercaptopurine. Methotrexate, a folate antagonist affecting thymidylate production, is commonly used alongside thiopurines as steroid-sparing agents for patients with UC and CD. Among these therapies, various different dosing strategies and routes of administration are used to manage active disease.

Initially, thiopurines were studied exclusively as monotherapy for the treatment of patients with steroid-intractable CD; however, results showed only marginal benefit when using these agents alone. As a result, combination trials were performed subsequently, and these revealed modest efficacy for use as maintenance therapies in both UC and CD. Further studies reported that methotrexate is beneficial only as a maintenance therapy for CD given that trial evidence confirmed treatment limitations in patients with UC.

“Thiopurines also have the potential to reduce postoperative recurrence of Crohn’s disease, in particular when administered with imidazole antibiotics,” the experts wrote. “There is currently no controlled data regarding the efficacy of methotrexate as maintenance therapy in ulcerative colitis,” they added.

Despite its limitations in UC, 25 mg of methotrexate administered intramuscularly once weekly in combination with oral steroids has shown benefits for inducing disease remission and limiting steroid use in the management of active CD. Comparatively, other trials have failed to show the same benefits with oral methotrexate. In addition, a number of clinical case series have reported benefit for use of methotrexate as a maintenance therapy for CD in patients who initially responded to methotrexate induction therapy.

Consequently, Dr. Hanauer and his colleagues recommended that methotrexate only be given in combination with biologics if being used for the treatment of UC.

“Thiopurines and methotrexate can be used in combination with anti-TNF biologics, in particular infliximab, to reduce immunogenicity and increase blood levels,” they stated.

One agent in particular, thioguanine, exhibits unique therapeutic efficacy in patients allergic to azathioprine or mercaptopurine. Despite this benefit, thioguanine use has been linked with an increased risk of developing hepatic nodular regenerative hyperplasia, as well as venoocclusive disease. Given these limitations, long-term use of thioguanine was not recommended by the authors.

With respect to safety, routine laboratory monitoring for both liver and hematologic adverse effects is recommended. In rare cases, patients may develop secondary lymphomas in response to thiopurine treatment. Moreover, regular follow-up is essential because of the higher prevalence of nonmelanoma skin cancers seen with thiopurines use.

“Patients using thiopurines for the treatment of IBD, particularly Caucasian patients, should avoid excessive sun exposure and use high-strength sun block,” the experts wrote. “Health care deliverers should ensure patients undergo appropriate dermatologic evaluations and investigate suspicious skin lesions in these patients,” they further reported.

Another important monitoring consideration is ongoing infection risk, in particular with opportunistic and viral pathogens. Because of the immunosuppressive effects of therapy, both methotrexate and thiopurine use are linked with a greater chance of developing these infections. Accordingly, Dr. Hanauer and his colleagues recommended that, before initiation of these therapies, applicable preventative measures should be taken, including administration of influenza, human papillomavirus, varicella zoster virus, pneumococcus, and hepatitis B vaccines.

“Live vaccines are contraindicated once therapy has begun; however, zoster vaccination can be given while patients are receiving azathioprine at less than 2 mg/kg,” they stated.

The experts went on to report that withdrawal of thiopurine agents, when used in combination therapy, has the potential to reduce therapeutic levels of infliximab and promote development of antidrug antibodies. However, the experts did not suggest a method to manage these complications. Further studies are needed to answer these and other remaining questions regarding thiopurine use in the setting of IBD.

SOURCE: Hanauer SB et al. Gastroenterology. 2018 Sep 6. doi: 10.1053/j.gastro.2018.08.043.

*This story was updated on January 4, 2019.

A new clinical practice update recommends combination therapy with tumor necrosis factor (TNF) inhibitors and thiopurines, as opposed to either therapy alone, for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD). The commentary was published in Gastroenterology.

Clinicians should also note that while several clinical trials use weight-based dosing to monitor clinical response following thiopurine therapy, 6-thioguanine levels have inevitably shown to better predict prognosis, wrote Stephen B. Hanauer, MD, AGAF, of Northwestern University in Chicago and his colleagues.

The thiopurine drug class is composed of many different agents, including thioguanine, azathioprine, and mercaptopurine. Methotrexate, a folate antagonist affecting thymidylate production, is commonly used alongside thiopurines as steroid-sparing agents for patients with UC and CD. Among these therapies, various different dosing strategies and routes of administration are used to manage active disease.

Initially, thiopurines were studied exclusively as monotherapy for the treatment of patients with steroid-intractable CD; however, results showed only marginal benefit when using these agents alone. As a result, combination trials were performed subsequently, and these revealed modest efficacy for use as maintenance therapies in both UC and CD. Further studies reported that methotrexate is beneficial only as a maintenance therapy for CD given that trial evidence confirmed treatment limitations in patients with UC.

“Thiopurines also have the potential to reduce postoperative recurrence of Crohn’s disease, in particular when administered with imidazole antibiotics,” the experts wrote. “There is currently no controlled data regarding the efficacy of methotrexate as maintenance therapy in ulcerative colitis,” they added.

Despite its limitations in UC, 25 mg of methotrexate administered intramuscularly once weekly in combination with oral steroids has shown benefits for inducing disease remission and limiting steroid use in the management of active CD. Comparatively, other trials have failed to show the same benefits with oral methotrexate. In addition, a number of clinical case series have reported benefit for use of methotrexate as a maintenance therapy for CD in patients who initially responded to methotrexate induction therapy.

Consequently, Dr. Hanauer and his colleagues recommended that methotrexate only be given in combination with biologics if being used for the treatment of UC.

“Thiopurines and methotrexate can be used in combination with anti-TNF biologics, in particular infliximab, to reduce immunogenicity and increase blood levels,” they stated.

One agent in particular, thioguanine, exhibits unique therapeutic efficacy in patients allergic to azathioprine or mercaptopurine. Despite this benefit, thioguanine use has been linked with an increased risk of developing hepatic nodular regenerative hyperplasia, as well as venoocclusive disease. Given these limitations, long-term use of thioguanine was not recommended by the authors.

With respect to safety, routine laboratory monitoring for both liver and hematologic adverse effects is recommended. In rare cases, patients may develop secondary lymphomas in response to thiopurine treatment. Moreover, regular follow-up is essential because of the higher prevalence of nonmelanoma skin cancers seen with thiopurines use.

“Patients using thiopurines for the treatment of IBD, particularly Caucasian patients, should avoid excessive sun exposure and use high-strength sun block,” the experts wrote. “Health care deliverers should ensure patients undergo appropriate dermatologic evaluations and investigate suspicious skin lesions in these patients,” they further reported.

Another important monitoring consideration is ongoing infection risk, in particular with opportunistic and viral pathogens. Because of the immunosuppressive effects of therapy, both methotrexate and thiopurine use are linked with a greater chance of developing these infections. Accordingly, Dr. Hanauer and his colleagues recommended that, before initiation of these therapies, applicable preventative measures should be taken, including administration of influenza, human papillomavirus, varicella zoster virus, pneumococcus, and hepatitis B vaccines.

“Live vaccines are contraindicated once therapy has begun; however, zoster vaccination can be given while patients are receiving azathioprine at less than 2 mg/kg,” they stated.

The experts went on to report that withdrawal of thiopurine agents, when used in combination therapy, has the potential to reduce therapeutic levels of infliximab and promote development of antidrug antibodies. However, the experts did not suggest a method to manage these complications. Further studies are needed to answer these and other remaining questions regarding thiopurine use in the setting of IBD.

SOURCE: Hanauer SB et al. Gastroenterology. 2018 Sep 6. doi: 10.1053/j.gastro.2018.08.043.

*This story was updated on January 4, 2019.

A new clinical practice update recommends combination therapy with tumor necrosis factor (TNF) inhibitors and thiopurines, as opposed to either therapy alone, for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD). The commentary was published in Gastroenterology.

Clinicians should also note that while several clinical trials use weight-based dosing to monitor clinical response following thiopurine therapy, 6-thioguanine levels have inevitably shown to better predict prognosis, wrote Stephen B. Hanauer, MD, AGAF, of Northwestern University in Chicago and his colleagues.

The thiopurine drug class is composed of many different agents, including thioguanine, azathioprine, and mercaptopurine. Methotrexate, a folate antagonist affecting thymidylate production, is commonly used alongside thiopurines as steroid-sparing agents for patients with UC and CD. Among these therapies, various different dosing strategies and routes of administration are used to manage active disease.

Initially, thiopurines were studied exclusively as monotherapy for the treatment of patients with steroid-intractable CD; however, results showed only marginal benefit when using these agents alone. As a result, combination trials were performed subsequently, and these revealed modest efficacy for use as maintenance therapies in both UC and CD. Further studies reported that methotrexate is beneficial only as a maintenance therapy for CD given that trial evidence confirmed treatment limitations in patients with UC.

“Thiopurines also have the potential to reduce postoperative recurrence of Crohn’s disease, in particular when administered with imidazole antibiotics,” the experts wrote. “There is currently no controlled data regarding the efficacy of methotrexate as maintenance therapy in ulcerative colitis,” they added.

Despite its limitations in UC, 25 mg of methotrexate administered intramuscularly once weekly in combination with oral steroids has shown benefits for inducing disease remission and limiting steroid use in the management of active CD. Comparatively, other trials have failed to show the same benefits with oral methotrexate. In addition, a number of clinical case series have reported benefit for use of methotrexate as a maintenance therapy for CD in patients who initially responded to methotrexate induction therapy.

Consequently, Dr. Hanauer and his colleagues recommended that methotrexate only be given in combination with biologics if being used for the treatment of UC.

“Thiopurines and methotrexate can be used in combination with anti-TNF biologics, in particular infliximab, to reduce immunogenicity and increase blood levels,” they stated.

One agent in particular, thioguanine, exhibits unique therapeutic efficacy in patients allergic to azathioprine or mercaptopurine. Despite this benefit, thioguanine use has been linked with an increased risk of developing hepatic nodular regenerative hyperplasia, as well as venoocclusive disease. Given these limitations, long-term use of thioguanine was not recommended by the authors.

With respect to safety, routine laboratory monitoring for both liver and hematologic adverse effects is recommended. In rare cases, patients may develop secondary lymphomas in response to thiopurine treatment. Moreover, regular follow-up is essential because of the higher prevalence of nonmelanoma skin cancers seen with thiopurines use.

“Patients using thiopurines for the treatment of IBD, particularly Caucasian patients, should avoid excessive sun exposure and use high-strength sun block,” the experts wrote. “Health care deliverers should ensure patients undergo appropriate dermatologic evaluations and investigate suspicious skin lesions in these patients,” they further reported.

Another important monitoring consideration is ongoing infection risk, in particular with opportunistic and viral pathogens. Because of the immunosuppressive effects of therapy, both methotrexate and thiopurine use are linked with a greater chance of developing these infections. Accordingly, Dr. Hanauer and his colleagues recommended that, before initiation of these therapies, applicable preventative measures should be taken, including administration of influenza, human papillomavirus, varicella zoster virus, pneumococcus, and hepatitis B vaccines.

“Live vaccines are contraindicated once therapy has begun; however, zoster vaccination can be given while patients are receiving azathioprine at less than 2 mg/kg,” they stated.

The experts went on to report that withdrawal of thiopurine agents, when used in combination therapy, has the potential to reduce therapeutic levels of infliximab and promote development of antidrug antibodies. However, the experts did not suggest a method to manage these complications. Further studies are needed to answer these and other remaining questions regarding thiopurine use in the setting of IBD.

SOURCE: Hanauer SB et al. Gastroenterology. 2018 Sep 6. doi: 10.1053/j.gastro.2018.08.043.

*This story was updated on January 4, 2019.

The surgical technique endoscopic submucosal dissection (ESD) is a safe and appropriate option for the complete resection of large, early-stage, malignant gastric lesions, according to a new clinical practice update from the American Gastroenterological Association published in Clinical Gastroenterology and Hepatology.

Clinicians should recognize ESD as one of the main treatment modalities for GI cancer enclosed within the superficial esophageal mucosa, which includes squamous cell dysplasia, wrote Peter V. Draganov, MD, of the University of Florida in Gainesville with his fellow experts.

Endoscopic resection is a surgical method used to treat both malignant and nonmalignant GI lesions. Over the past several years, the technique has advanced significantly, progressing from snare polypectomy to endoscopic mucosal resection, with current practice now ESD. The minimally invasive technique is considered first-line therapy in patients with colorectal lesions lacking invasive cancer.

While the technique is widely used in Asian countries, and as practice continues to rise throughout Europe, uptake in the United States has been slow. Several factors may be responsible for this delay, including a lack of ESD experts and training centers, underestimation of the benefits associated with ESD, and a likely bias of American oncologists toward treatment with surgical resection. In recent years, extensive improvements have occurred in ESD technique, such as incorporation of pocket and tunnel strategies, which have significantly contributed to the overall safety and efficacy of the procedure.

“With low thresholds for performing endoscopy for upper GI symptoms and the promotion of screening colonoscopy for colon cancer prevention, more precancerous lesions and early cancers are being detected that may be amenable to endoscopic resection by ESD,” the experts wrote.

For mucosal lesions too large to be removed by standard endoscopic resection, or lesions at high risk of being deemed malignant, the guidelines recommend using ESD to remove these lesions. Dr. Draganov and his colleagues acknowledged that the probability of lymph node metastasis is marginally higher when the procedure is used for these widened indications; however, the risk of metastasis remains sufficiently low. Along those lines, several additional recommendations were made related to the expanded indications for ESD, including use in certain patients with Barrett’s esophagus, colorectal neoplasia, and other forms of superficial gastric cancer.

“Expanded indications for gastric ESD include moderately and well-differentiated superficial cancers that are [more than] 2 cm, lesions [up to] 3 cm with ulceration or that contain early submucosal invasion, and poorly differentiated superficial cancers [up to] 2 cm in size,” the experts stated.

With respect to cost, endoscopic resection was found to provide significant savings in comparison to surgical techniques for the removal of colorectal lesions. The economic analysis revealed that using a lesion-specific ESD model for high-risk patients could allow for notable cost reductions.

“Although some insurers have begun preapproving and covering their members who might benefit from ESD, the hurdles preventing other patients from being covered for this innovative and potentially cost-saving procedure should be removed,” they added.

Other recommendations were made in regards to effective implementation of a stepwise ESD educational model to train American endoscopists on how to properly perform the procedure. The proposed strategy involves completion of a formal training program, independent study, self-practice using animal models, and live viewing of cases by ESD experts. In addition, they recommend that newly trained endoscopists complete their first procedures on patients with absolute indications for ESD.

“At present, there is no standardized approach for ESD training in the United States,” the experts wrote. They further explained that “the usual starting point is to attend an ESD course or series of courses that provide increasingly more in-depth exposure.” And they concluded, “a guiding principle should be that our patients’ interests and welfare stand above all else and that patients must not be used as an opportunity for practice or skills acquisition.”

The practice update also recommends that endoscopists avoid the use of techniques that have the ability to produce submucosal fibrosis. Dr. Draganov and his colleagues warn that these practices, such as “tattooing in close proximity to or beneath a lesion for marking” and “partial snare resection of a portion of a lesion for histopathology,” can impede subsequent endoscopic procedures.

Dr. Draganov and several coauthors disclosed financial affiliations with AbbVie, Boston Scientific Corporation, Cook Medical, Olympus America, and others.

SOURCE: Draganov PV et al. Clin Gastroenterol Hepatol. 2018 Aug 2. doi: 10.1016/j.cgh.2018.07.041.

The surgical technique endoscopic submucosal dissection (ESD) is a safe and appropriate option for the complete resection of large, early-stage, malignant gastric lesions, according to a new clinical practice update from the American Gastroenterological Association published in Clinical Gastroenterology and Hepatology.

Clinicians should recognize ESD as one of the main treatment modalities for GI cancer enclosed within the superficial esophageal mucosa, which includes squamous cell dysplasia, wrote Peter V. Draganov, MD, of the University of Florida in Gainesville with his fellow experts.

Endoscopic resection is a surgical method used to treat both malignant and nonmalignant GI lesions. Over the past several years, the technique has advanced significantly, progressing from snare polypectomy to endoscopic mucosal resection, with current practice now ESD. The minimally invasive technique is considered first-line therapy in patients with colorectal lesions lacking invasive cancer.

While the technique is widely used in Asian countries, and as practice continues to rise throughout Europe, uptake in the United States has been slow. Several factors may be responsible for this delay, including a lack of ESD experts and training centers, underestimation of the benefits associated with ESD, and a likely bias of American oncologists toward treatment with surgical resection. In recent years, extensive improvements have occurred in ESD technique, such as incorporation of pocket and tunnel strategies, which have significantly contributed to the overall safety and efficacy of the procedure.

“With low thresholds for performing endoscopy for upper GI symptoms and the promotion of screening colonoscopy for colon cancer prevention, more precancerous lesions and early cancers are being detected that may be amenable to endoscopic resection by ESD,” the experts wrote.

For mucosal lesions too large to be removed by standard endoscopic resection, or lesions at high risk of being deemed malignant, the guidelines recommend using ESD to remove these lesions. Dr. Draganov and his colleagues acknowledged that the probability of lymph node metastasis is marginally higher when the procedure is used for these widened indications; however, the risk of metastasis remains sufficiently low. Along those lines, several additional recommendations were made related to the expanded indications for ESD, including use in certain patients with Barrett’s esophagus, colorectal neoplasia, and other forms of superficial gastric cancer.

“Expanded indications for gastric ESD include moderately and well-differentiated superficial cancers that are [more than] 2 cm, lesions [up to] 3 cm with ulceration or that contain early submucosal invasion, and poorly differentiated superficial cancers [up to] 2 cm in size,” the experts stated.

With respect to cost, endoscopic resection was found to provide significant savings in comparison to surgical techniques for the removal of colorectal lesions. The economic analysis revealed that using a lesion-specific ESD model for high-risk patients could allow for notable cost reductions.

“Although some insurers have begun preapproving and covering their members who might benefit from ESD, the hurdles preventing other patients from being covered for this innovative and potentially cost-saving procedure should be removed,” they added.

Other recommendations were made in regards to effective implementation of a stepwise ESD educational model to train American endoscopists on how to properly perform the procedure. The proposed strategy involves completion of a formal training program, independent study, self-practice using animal models, and live viewing of cases by ESD experts. In addition, they recommend that newly trained endoscopists complete their first procedures on patients with absolute indications for ESD.

“At present, there is no standardized approach for ESD training in the United States,” the experts wrote. They further explained that “the usual starting point is to attend an ESD course or series of courses that provide increasingly more in-depth exposure.” And they concluded, “a guiding principle should be that our patients’ interests and welfare stand above all else and that patients must not be used as an opportunity for practice or skills acquisition.”

The practice update also recommends that endoscopists avoid the use of techniques that have the ability to produce submucosal fibrosis. Dr. Draganov and his colleagues warn that these practices, such as “tattooing in close proximity to or beneath a lesion for marking” and “partial snare resection of a portion of a lesion for histopathology,” can impede subsequent endoscopic procedures.

Dr. Draganov and several coauthors disclosed financial affiliations with AbbVie, Boston Scientific Corporation, Cook Medical, Olympus America, and others.

SOURCE: Draganov PV et al. Clin Gastroenterol Hepatol. 2018 Aug 2. doi: 10.1016/j.cgh.2018.07.041.

The surgical technique endoscopic submucosal dissection (ESD) is a safe and appropriate option for the complete resection of large, early-stage, malignant gastric lesions, according to a new clinical practice update from the American Gastroenterological Association published in Clinical Gastroenterology and Hepatology.

Clinicians should recognize ESD as one of the main treatment modalities for GI cancer enclosed within the superficial esophageal mucosa, which includes squamous cell dysplasia, wrote Peter V. Draganov, MD, of the University of Florida in Gainesville with his fellow experts.

Endoscopic resection is a surgical method used to treat both malignant and nonmalignant GI lesions. Over the past several years, the technique has advanced significantly, progressing from snare polypectomy to endoscopic mucosal resection, with current practice now ESD. The minimally invasive technique is considered first-line therapy in patients with colorectal lesions lacking invasive cancer.

While the technique is widely used in Asian countries, and as practice continues to rise throughout Europe, uptake in the United States has been slow. Several factors may be responsible for this delay, including a lack of ESD experts and training centers, underestimation of the benefits associated with ESD, and a likely bias of American oncologists toward treatment with surgical resection. In recent years, extensive improvements have occurred in ESD technique, such as incorporation of pocket and tunnel strategies, which have significantly contributed to the overall safety and efficacy of the procedure.

“With low thresholds for performing endoscopy for upper GI symptoms and the promotion of screening colonoscopy for colon cancer prevention, more precancerous lesions and early cancers are being detected that may be amenable to endoscopic resection by ESD,” the experts wrote.

For mucosal lesions too large to be removed by standard endoscopic resection, or lesions at high risk of being deemed malignant, the guidelines recommend using ESD to remove these lesions. Dr. Draganov and his colleagues acknowledged that the probability of lymph node metastasis is marginally higher when the procedure is used for these widened indications; however, the risk of metastasis remains sufficiently low. Along those lines, several additional recommendations were made related to the expanded indications for ESD, including use in certain patients with Barrett’s esophagus, colorectal neoplasia, and other forms of superficial gastric cancer.

“Expanded indications for gastric ESD include moderately and well-differentiated superficial cancers that are [more than] 2 cm, lesions [up to] 3 cm with ulceration or that contain early submucosal invasion, and poorly differentiated superficial cancers [up to] 2 cm in size,” the experts stated.

With respect to cost, endoscopic resection was found to provide significant savings in comparison to surgical techniques for the removal of colorectal lesions. The economic analysis revealed that using a lesion-specific ESD model for high-risk patients could allow for notable cost reductions.

“Although some insurers have begun preapproving and covering their members who might benefit from ESD, the hurdles preventing other patients from being covered for this innovative and potentially cost-saving procedure should be removed,” they added.

Other recommendations were made in regards to effective implementation of a stepwise ESD educational model to train American endoscopists on how to properly perform the procedure. The proposed strategy involves completion of a formal training program, independent study, self-practice using animal models, and live viewing of cases by ESD experts. In addition, they recommend that newly trained endoscopists complete their first procedures on patients with absolute indications for ESD.

“At present, there is no standardized approach for ESD training in the United States,” the experts wrote. They further explained that “the usual starting point is to attend an ESD course or series of courses that provide increasingly more in-depth exposure.” And they concluded, “a guiding principle should be that our patients’ interests and welfare stand above all else and that patients must not be used as an opportunity for practice or skills acquisition.”

The practice update also recommends that endoscopists avoid the use of techniques that have the ability to produce submucosal fibrosis. Dr. Draganov and his colleagues warn that these practices, such as “tattooing in close proximity to or beneath a lesion for marking” and “partial snare resection of a portion of a lesion for histopathology,” can impede subsequent endoscopic procedures.

Dr. Draganov and several coauthors disclosed financial affiliations with AbbVie, Boston Scientific Corporation, Cook Medical, Olympus America, and others.

SOURCE: Draganov PV et al. Clin Gastroenterol Hepatol. 2018 Aug 2. doi: 10.1016/j.cgh.2018.07.041.

Newly released criteria aim to advise clinicians about the most appropriate interventions for managing peripheral artery disease.

The report, published in the Journal of the American College of Cardiology, drew on the expertise of a broad panel of experts, including representatives from the American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and Society for Vascular Medicine.

“Improvements in the diagnosis of peripheral artery disease (PAD) have led to an increasing number of treatment and revascularization methods, especially endovascular interventions,” wrote Steven R. Bailey, MD, who headed the multidisciplinary writing committee. “As new and increasingly sophisticated devices are developed, the medical community needs to understand how best to incorporate these technologies into daily clinical decision making and care, and how to choose between new and more established methods. This project was initiated to respond to this need and to ensure the effective use of peripheral artery revascularization.”

The document is not intended to cover every possible clinical scenario that could employ these interventions, wrote Dr. Bailey, who is the Janey Briscoe Distinguished Chair in Cardiology at the University of Texas, San Antonio, and his coauthors. “Rather, the goal is to provide generalized guidance into the use of these devices and techniques, while understanding that each clinical situation is unique, with physicians using their best judgment and the available evidence base to craft the most beneficial approach for the patient. In all cases, it is assumed that guideline-directed medical therapy should be applied first.”

The panel identified 45 scenarios in key clinical areas in which PAD interventions – either surgical or endovascular procedures – might be employed as first-line therapy. These included renal artery stenosis, lower extremity disease, critical limb ischemia, and asymptomatic artery disease. The report also discussed options for endovascular interventions, and secondary treatment options for lower extremity disease. The panel graded the value of interventions as appropriate, may be appropriate, or rarely appropriate.

“The scenarios in this document are arranged according to the clinical decision points confronting vascular practitioners in everyday clinical practice,” the panel wrote. “These include the presence or absence of symptoms, presence or absence of limb-threatening disease, severity and anatomical location of the culprit lesion, recurrent or de novo disease, the advantage of endovascular or surgical revascularization, and the expected durability of clinical benefit after an intervention.”

Renal artery stenting

Recommendations in this category were largely based on the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) study, which recommends best medical therapy as the initial treatment for a newly diagnosed patient. (N Engl J Med 2014;370:13-22).

The optimal medical approach is generally thought to be three antihypertensive medications, one of which should be a diuretic. Primary stenting can be considered for patients with an accelerating decline in renal function and bilateral or solitary significant renal artery stenosis, or moderate stenosis with translesional gradients that exceed threshold measurements. In patients with stable renal function and unilateral significant stenosis, intensifying medical therapy is appropriate. Stenting is rarely appropriate in patients with small, nonviable kidneys.

Lower extremity disease

Recommendations for lower extremity revascularization in patients with claudication are based largely on the 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease.

For patients with PAD and intermittent claudication, medical therapy and exercise are the first-line treatments. Revascularization should be considered only when this option fails. The appropriateness of intervention depends on the location and length of the lesion.

Intensification of medical therapy or endovascular treatment are appropriate for patients with aortoiliac, superficial femoral artery, and popliteal artery lesions; surgery also may be appropriate here. Medical therapy is appropriate for lesions located below the knee, as well; endovascular approaches also may be appropriate. Surgery for these lesions is rarely appropriate.

Critical limb ischemia

Medical therapy is generally not considered for these patients. But regardless of the lesion location, the panel found either endovascular or surgical treatment appropriate. Indeed, revascularization is the only viable treatment for these patients.

“Revascularization, whether endovascular or surgical, is critical for the reduction of high morbidity and mortality rates associated with limb loss. Mortality rates have been reported to be as high as 20% within 6 months of diagnosis and exceeding 50% after 5 years in patients left untreated. Furthermore, this degree of PAD is commonly associated with excessive cardiovascular events, often surpassing mortality rates associated with even symptomatic coronary artery disease.”

Asymptomatic artery disease

The recommendations in this category address the need to gain arterial access for potentially life-saving cardiovascular procedures. There are no published data in this area, so the recommendations are all based on expert opinion.

To gain access for coronary interventions, endovascular treatment and surgery are both appropriate. For hemodynamic support and large vascular or valvular interventions, endovascular approaches are appropriate, and surgical approaches may be appropriate.

Options for endovascular treatment when deemed appropriate or may be appropriate

Since there is no standardized treatment when an intervention is deemed appropriate, the potential procedures are organized by general lesion location (above or below the inguinal ligament and below the knee), and by lesion length. The recommendations cover the most commonly used endovascular treatment modalities.

“Of note, the use of atherectomy in the iliac artery has been rated Rarely Appropriate in all clinical scenarios,” the team noted. “This rating derives from an absence of data supporting the use of this technology, compared with balloon angioplasty and stenting. Similarly, the use of atherectomy in the superficial femoral and popliteal arteries and below-the-knee vessels also received a lower score, again because of the lack of comparative data relative to technologies with prospectively collected data. The evidence base to judge intervention below the knees is not as developed as other lower-extremity locations, which results in more frequent use of the May Be Appropriate category. The rating panel felt that below-the-knee atherectomy once again lacked comparative evidence to support general use.”

There are some exceptions, “favoring atherectomy include severe calcification and undilatable lesions; however, other technologies had a better evidence base for routine revascularization in most settings.”

Secondary treatment options for lower-extremity disease

This section addresses options for very specific situations, including in-stent restenosis, venous bypass graft failure, and prosthetic bypass graft failure.

“It is recognized that the need for revascularization of a failing conduit, graft, or stent is a marker of adverse outcomes for all of the reparative modalities employed,” the panel wrote. “Literature comparing treatment modalities for in-stent stenosis, venous graft failures, and arterial graft failures is very limited. Therefore, the recommendations primarily reflect consensus based upon current clinical practice.”

The modality choice should probably depend more upon surgeon preference and clinical experience, rather than a blanket recommendation. In general, the panel felt that surgical revascularizations are rarely appropriate for in-stent stenosis, especially if the patient is asymptomatic.

The panel felt that endovascular approaches are generally appropriate for focal stenoses in patients with prior surgical grafts and bioprosthetic material, but in patients with diffused stenosis or thrombosed grafts, both endovascular and surgical approaches were graded as may be appropriate.

“The specific type of therapy [device or surgical procedure] is at the discretion of the clinician, dictated by the clinical scenario plus physician and facility experience.”

Dr. Bailey had no financial disclosures; however, some members of the panel did disclose relationships with device manufacturers and pharmaceutical companies.
 

[email protected]

SOURCE: Bailey SR et al. J Am Coll Cardiol. 2018 Dec 17.
 

Newly released criteria aim to advise clinicians about the most appropriate interventions for managing peripheral artery disease.

The report, published in the Journal of the American College of Cardiology, drew on the expertise of a broad panel of experts, including representatives from the American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and Society for Vascular Medicine.

“Improvements in the diagnosis of peripheral artery disease (PAD) have led to an increasing number of treatment and revascularization methods, especially endovascular interventions,” wrote Steven R. Bailey, MD, who headed the multidisciplinary writing committee. “As new and increasingly sophisticated devices are developed, the medical community needs to understand how best to incorporate these technologies into daily clinical decision making and care, and how to choose between new and more established methods. This project was initiated to respond to this need and to ensure the effective use of peripheral artery revascularization.”

The document is not intended to cover every possible clinical scenario that could employ these interventions, wrote Dr. Bailey, who is the Janey Briscoe Distinguished Chair in Cardiology at the University of Texas, San Antonio, and his coauthors. “Rather, the goal is to provide generalized guidance into the use of these devices and techniques, while understanding that each clinical situation is unique, with physicians using their best judgment and the available evidence base to craft the most beneficial approach for the patient. In all cases, it is assumed that guideline-directed medical therapy should be applied first.”

The panel identified 45 scenarios in key clinical areas in which PAD interventions – either surgical or endovascular procedures – might be employed as first-line therapy. These included renal artery stenosis, lower extremity disease, critical limb ischemia, and asymptomatic artery disease. The report also discussed options for endovascular interventions, and secondary treatment options for lower extremity disease. The panel graded the value of interventions as appropriate, may be appropriate, or rarely appropriate.

“The scenarios in this document are arranged according to the clinical decision points confronting vascular practitioners in everyday clinical practice,” the panel wrote. “These include the presence or absence of symptoms, presence or absence of limb-threatening disease, severity and anatomical location of the culprit lesion, recurrent or de novo disease, the advantage of endovascular or surgical revascularization, and the expected durability of clinical benefit after an intervention.”

Renal artery stenting

Recommendations in this category were largely based on the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) study, which recommends best medical therapy as the initial treatment for a newly diagnosed patient. (N Engl J Med 2014;370:13-22).

The optimal medical approach is generally thought to be three antihypertensive medications, one of which should be a diuretic. Primary stenting can be considered for patients with an accelerating decline in renal function and bilateral or solitary significant renal artery stenosis, or moderate stenosis with translesional gradients that exceed threshold measurements. In patients with stable renal function and unilateral significant stenosis, intensifying medical therapy is appropriate. Stenting is rarely appropriate in patients with small, nonviable kidneys.

Lower extremity disease

Recommendations for lower extremity revascularization in patients with claudication are based largely on the 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease.

For patients with PAD and intermittent claudication, medical therapy and exercise are the first-line treatments. Revascularization should be considered only when this option fails. The appropriateness of intervention depends on the location and length of the lesion.

Intensification of medical therapy or endovascular treatment are appropriate for patients with aortoiliac, superficial femoral artery, and popliteal artery lesions; surgery also may be appropriate here. Medical therapy is appropriate for lesions located below the knee, as well; endovascular approaches also may be appropriate. Surgery for these lesions is rarely appropriate.

Critical limb ischemia

Medical therapy is generally not considered for these patients. But regardless of the lesion location, the panel found either endovascular or surgical treatment appropriate. Indeed, revascularization is the only viable treatment for these patients.

“Revascularization, whether endovascular or surgical, is critical for the reduction of high morbidity and mortality rates associated with limb loss. Mortality rates have been reported to be as high as 20% within 6 months of diagnosis and exceeding 50% after 5 years in patients left untreated. Furthermore, this degree of PAD is commonly associated with excessive cardiovascular events, often surpassing mortality rates associated with even symptomatic coronary artery disease.”

Asymptomatic artery disease

The recommendations in this category address the need to gain arterial access for potentially life-saving cardiovascular procedures. There are no published data in this area, so the recommendations are all based on expert opinion.

To gain access for coronary interventions, endovascular treatment and surgery are both appropriate. For hemodynamic support and large vascular or valvular interventions, endovascular approaches are appropriate, and surgical approaches may be appropriate.

Options for endovascular treatment when deemed appropriate or may be appropriate

Since there is no standardized treatment when an intervention is deemed appropriate, the potential procedures are organized by general lesion location (above or below the inguinal ligament and below the knee), and by lesion length. The recommendations cover the most commonly used endovascular treatment modalities.

“Of note, the use of atherectomy in the iliac artery has been rated Rarely Appropriate in all clinical scenarios,” the team noted. “This rating derives from an absence of data supporting the use of this technology, compared with balloon angioplasty and stenting. Similarly, the use of atherectomy in the superficial femoral and popliteal arteries and below-the-knee vessels also received a lower score, again because of the lack of comparative data relative to technologies with prospectively collected data. The evidence base to judge intervention below the knees is not as developed as other lower-extremity locations, which results in more frequent use of the May Be Appropriate category. The rating panel felt that below-the-knee atherectomy once again lacked comparative evidence to support general use.”

There are some exceptions, “favoring atherectomy include severe calcification and undilatable lesions; however, other technologies had a better evidence base for routine revascularization in most settings.”

Secondary treatment options for lower-extremity disease

This section addresses options for very specific situations, including in-stent restenosis, venous bypass graft failure, and prosthetic bypass graft failure.

“It is recognized that the need for revascularization of a failing conduit, graft, or stent is a marker of adverse outcomes for all of the reparative modalities employed,” the panel wrote. “Literature comparing treatment modalities for in-stent stenosis, venous graft failures, and arterial graft failures is very limited. Therefore, the recommendations primarily reflect consensus based upon current clinical practice.”

The modality choice should probably depend more upon surgeon preference and clinical experience, rather than a blanket recommendation. In general, the panel felt that surgical revascularizations are rarely appropriate for in-stent stenosis, especially if the patient is asymptomatic.

The panel felt that endovascular approaches are generally appropriate for focal stenoses in patients with prior surgical grafts and bioprosthetic material, but in patients with diffused stenosis or thrombosed grafts, both endovascular and surgical approaches were graded as may be appropriate.

“The specific type of therapy [device or surgical procedure] is at the discretion of the clinician, dictated by the clinical scenario plus physician and facility experience.”

Dr. Bailey had no financial disclosures; however, some members of the panel did disclose relationships with device manufacturers and pharmaceutical companies.
 

[email protected]

SOURCE: Bailey SR et al. J Am Coll Cardiol. 2018 Dec 17.
 

Newly released criteria aim to advise clinicians about the most appropriate interventions for managing peripheral artery disease.

The report, published in the Journal of the American College of Cardiology, drew on the expertise of a broad panel of experts, including representatives from the American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and Society for Vascular Medicine.

“Improvements in the diagnosis of peripheral artery disease (PAD) have led to an increasing number of treatment and revascularization methods, especially endovascular interventions,” wrote Steven R. Bailey, MD, who headed the multidisciplinary writing committee. “As new and increasingly sophisticated devices are developed, the medical community needs to understand how best to incorporate these technologies into daily clinical decision making and care, and how to choose between new and more established methods. This project was initiated to respond to this need and to ensure the effective use of peripheral artery revascularization.”

The document is not intended to cover every possible clinical scenario that could employ these interventions, wrote Dr. Bailey, who is the Janey Briscoe Distinguished Chair in Cardiology at the University of Texas, San Antonio, and his coauthors. “Rather, the goal is to provide generalized guidance into the use of these devices and techniques, while understanding that each clinical situation is unique, with physicians using their best judgment and the available evidence base to craft the most beneficial approach for the patient. In all cases, it is assumed that guideline-directed medical therapy should be applied first.”

The panel identified 45 scenarios in key clinical areas in which PAD interventions – either surgical or endovascular procedures – might be employed as first-line therapy. These included renal artery stenosis, lower extremity disease, critical limb ischemia, and asymptomatic artery disease. The report also discussed options for endovascular interventions, and secondary treatment options for lower extremity disease. The panel graded the value of interventions as appropriate, may be appropriate, or rarely appropriate.

“The scenarios in this document are arranged according to the clinical decision points confronting vascular practitioners in everyday clinical practice,” the panel wrote. “These include the presence or absence of symptoms, presence or absence of limb-threatening disease, severity and anatomical location of the culprit lesion, recurrent or de novo disease, the advantage of endovascular or surgical revascularization, and the expected durability of clinical benefit after an intervention.”

Renal artery stenting

Recommendations in this category were largely based on the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) study, which recommends best medical therapy as the initial treatment for a newly diagnosed patient. (N Engl J Med 2014;370:13-22).

The optimal medical approach is generally thought to be three antihypertensive medications, one of which should be a diuretic. Primary stenting can be considered for patients with an accelerating decline in renal function and bilateral or solitary significant renal artery stenosis, or moderate stenosis with translesional gradients that exceed threshold measurements. In patients with stable renal function and unilateral significant stenosis, intensifying medical therapy is appropriate. Stenting is rarely appropriate in patients with small, nonviable kidneys.

Lower extremity disease

Recommendations for lower extremity revascularization in patients with claudication are based largely on the 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease.

For patients with PAD and intermittent claudication, medical therapy and exercise are the first-line treatments. Revascularization should be considered only when this option fails. The appropriateness of intervention depends on the location and length of the lesion.

Intensification of medical therapy or endovascular treatment are appropriate for patients with aortoiliac, superficial femoral artery, and popliteal artery lesions; surgery also may be appropriate here. Medical therapy is appropriate for lesions located below the knee, as well; endovascular approaches also may be appropriate. Surgery for these lesions is rarely appropriate.

Critical limb ischemia

Medical therapy is generally not considered for these patients. But regardless of the lesion location, the panel found either endovascular or surgical treatment appropriate. Indeed, revascularization is the only viable treatment for these patients.

“Revascularization, whether endovascular or surgical, is critical for the reduction of high morbidity and mortality rates associated with limb loss. Mortality rates have been reported to be as high as 20% within 6 months of diagnosis and exceeding 50% after 5 years in patients left untreated. Furthermore, this degree of PAD is commonly associated with excessive cardiovascular events, often surpassing mortality rates associated with even symptomatic coronary artery disease.”

Asymptomatic artery disease

The recommendations in this category address the need to gain arterial access for potentially life-saving cardiovascular procedures. There are no published data in this area, so the recommendations are all based on expert opinion.

To gain access for coronary interventions, endovascular treatment and surgery are both appropriate. For hemodynamic support and large vascular or valvular interventions, endovascular approaches are appropriate, and surgical approaches may be appropriate.

Options for endovascular treatment when deemed appropriate or may be appropriate

Since there is no standardized treatment when an intervention is deemed appropriate, the potential procedures are organized by general lesion location (above or below the inguinal ligament and below the knee), and by lesion length. The recommendations cover the most commonly used endovascular treatment modalities.

“Of note, the use of atherectomy in the iliac artery has been rated Rarely Appropriate in all clinical scenarios,” the team noted. “This rating derives from an absence of data supporting the use of this technology, compared with balloon angioplasty and stenting. Similarly, the use of atherectomy in the superficial femoral and popliteal arteries and below-the-knee vessels also received a lower score, again because of the lack of comparative data relative to technologies with prospectively collected data. The evidence base to judge intervention below the knees is not as developed as other lower-extremity locations, which results in more frequent use of the May Be Appropriate category. The rating panel felt that below-the-knee atherectomy once again lacked comparative evidence to support general use.”

There are some exceptions, “favoring atherectomy include severe calcification and undilatable lesions; however, other technologies had a better evidence base for routine revascularization in most settings.”

Secondary treatment options for lower-extremity disease

This section addresses options for very specific situations, including in-stent restenosis, venous bypass graft failure, and prosthetic bypass graft failure.

“It is recognized that the need for revascularization of a failing conduit, graft, or stent is a marker of adverse outcomes for all of the reparative modalities employed,” the panel wrote. “Literature comparing treatment modalities for in-stent stenosis, venous graft failures, and arterial graft failures is very limited. Therefore, the recommendations primarily reflect consensus based upon current clinical practice.”

The modality choice should probably depend more upon surgeon preference and clinical experience, rather than a blanket recommendation. In general, the panel felt that surgical revascularizations are rarely appropriate for in-stent stenosis, especially if the patient is asymptomatic.

The panel felt that endovascular approaches are generally appropriate for focal stenoses in patients with prior surgical grafts and bioprosthetic material, but in patients with diffused stenosis or thrombosed grafts, both endovascular and surgical approaches were graded as may be appropriate.

“The specific type of therapy [device or surgical procedure] is at the discretion of the clinician, dictated by the clinical scenario plus physician and facility experience.”

Dr. Bailey had no financial disclosures; however, some members of the panel did disclose relationships with device manufacturers and pharmaceutical companies.
 

[email protected]

SOURCE: Bailey SR et al. J Am Coll Cardiol. 2018 Dec 17.