For many years, the approach to the diagnosis of hypertension was straight-forward—multiple blood pressure (BP) measurements ≥140/90 mm Hg established the diagnosis of hypertension, a disease associated with an increased risk of adverse cardiovascular events, including myocardial infarction and stroke. For more than a decade, hypertension experts have argued that a BP ≥130/80 mm Hg should establish the diagnosis of hypertension. Many clinicians resisted the change because it would markedly increase the number of asymptomatic adults with the diagnosis, increasing the number needing treatment. However, the findings of the Systolic Blood Pressure Intervention Trial (SPRINT) and other observational studies have catalyzed the American College of Cardiology (ACC) and the American Heart Association (AHA) to redefine normal BP as <120/80 mm Hg.¹ This change will expand the diagnosis of hypertension to include up to 50% of American adults.¹ In addition, the new definition of normal BP will result in the greater use of lifestyle interventions and antihypertensive medications to achieve the new normal, a BP of <120/80 mm Hg.

The new definition of hypertension

The new definition of hypertension is of particular importance for people at risk for developing cardiovascular disease (CVD) ^1,2 and is summarized here.

• Normal BP: systolic BP (SBP) <120 mm Hg and diastolic BP (DBP) <80 mm Hg
• Elevated BP: SBP 120–129 mm Hg and DBP <80 mm Hg
• Stage 1 hypertension: SBP 130–139 mm Hg or DBP 80–89 mm Hg.
• Stage 2 hypertension: SBP ≥140 mm Hg or DBP ≥90 mm Hg.

The new definition of hypertension will markedly increase the number of mid-life adults eligible to be treated for hypertension. I summarize the approach to treating hypertension in this article.

For mid-life adults, a SBP of <120 mm Hg is better for the heart
The heart is a pump, and not surprisingly, if a pump can achieve its job at a lower rather than a higher pressure, it is likely to last longer. The SPRINT study clearly demonstrated that in elderly hypertensive adults, an SBP target of <120 mm Hg is associated with fewer deaths than a SBP in the range of 130 to 140 mm Hg.³

In the SPRINT trial, 9,361 people with a mean age, body mass index, and BP of 68 years, 30 kg/m² and 140/78 mm Hg, respectively, were randomly assigned to intensive treatment of SBP to a goal of <120 mm Hg or to a target of <140 mm Hg. After 1 year of treatment, the intensive treatment group had a mean SBP of 121 mm Hg and the standard treatment group had a mean SBP of 136 mm Hg. To achieve a SBP <120 mm Hg, most patients required 3 antihypertensive medications, in contrast to the 2 antihypertensive medications typically needed to achieve a SBP in the range of 130 to 140 mm Hg.

After a median of 3.3 years of follow-up, significantly fewer deaths occurred in the intensive treatment group than in the standard treatment group, including deaths from all causes (3.3% vs 4.5%, P = .003) and deaths from CVD (0.8% vs 1.4%; P = .005). In addition, the risk of developing heart failure was lower in the intensive treatment than in the standard treatment group (1.3% vs 2.1%, P = .002). There was no difference between the 2 groups in the risk of stroke (1.3% vs 1.5%, P = .50) or myocardial infarction (2.1% vs 2.5%, P = .19). The rate of syncope was higher in the intensive treatment group (2.3% vs 1.7% in the standard treatment group, P = .05).³ Self-reported mental and physical health and satisfaction with treatment was similar in both groups.⁴

The investigators concluded that among people at risk for CVD, targeting a SBP of <120 mm Hg as compared to <140 mm Hg resulted in lower rates of heart failure and death, two clinically meaningful endpoints.

Read about nonpharmacologic interventions and antihypertensive medications to treat hypertension.

Diet and exercise

Nonpharmacologic interventions, including diet and exercise, are recommended for all people with a BP >120/80 mm Hg. In most situations, antihypertensive medications are not necessary if the patient has elevated BP (SBP 120–129 mm Hg and DBP <80 mm Hg) or Stage 1 hypertension (SBP 130–139 mm Hg or DBP 80–89 mm Hg) and a 10-year CVD risk of less than 10% using the ACC/AHA cardiovascular risk calculator⁵ (see http://www.cvriskcalcula tor.com/). For people at low risk for CVD, nonpharmacologic interventions, including diet and exercise, are often sufficient treatment.

The Dietary Approaches to Stop Hypertension (DASH) diet emphasizes increasing consumption of fruits, vegetables, low-fat dairy, whole-grains, fish, poultry, and nuts and decreasing the consumption of red meats, sugary drinks, sweets, sodium, and saturated and trans-fats. In randomized trials, the DASH diet is associated with a reduction in BP of approximately 5 mm Hg systolic and 3 mm Hg diastolic.⁶ The DASH trial monitored weight changes and adjusted calorie intake to ensure a stabilized weight throughout the study. Hence, the positive effect of the DASH diet was observed in the absence of any weight loss. Weight loss also can decrease BP with every 1- to 2-lb weight loss, reducing SBP by approximately 1 mm Hg.⁷ Combining the DASH diet with a low-sodium diet is especially important in people with high sodium intake, and is reported to reduce SBP by 5 to 20 mm Hg.⁸ Reducing the consumption of alcohol can result in a reduction of SBP and DBP in the range of 3 and 2 mm Hg, respectively.⁹

Exercising for 40 minutes, 3 to 4 times per week is associated with a reduction of SBP and DBP of approximately 5 and 3 mm Hg, respectively.¹⁰ Although the studies are of low quality, meditation is reported to decrease SBP and DBP by 4 and 2 mm Hg, respectively.¹¹

Antihypertensive medications

For all mid-life adults with Stage 2hypertension (SBP ≥140 mm Hg or DBP ≥90 mm Hg) or with both clinical CVD and Stage 1 hypertension, antihypertensive medications are recommended.¹ For people with Stage 1 hypertension and a 10-year CVD risk of ≥10%, antihypertensive medications are recommended. The target BP is <130/80 mm Hg for most people.

The recommended antihypertensive medications include thiazide diuretics, calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, and angiotensin II receptor blockers (ARBs). Many patients with Stage 2 hypertension will need treatment with 2 agents of different classes to achieve a BP <130/80 mm Hg. Some experts believe that an optimal 2-agent regimen includes an ACE or ARB plus a CCB based on the results of the ACCOMPLISH trial.¹² In this trial, 11,506 adults with hypertension and at very high risk for CVD, were randomly assigned to treatment with an ACE inhibitor plus CCB or with an ACE inhibitor plus hydrochlorothiazide. The BP achieved in both groups was approximately 132/73 mm Hg. The study was stopped after 3 years because participants in the ACE/thiazide group had a higher rate of adverse cardiovascular events (myocardial infarction, stroke, or death) than those in the ACE/CCB group (11.8% vs 9.6%; hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.72–0.90; P<.001). Compared to the ACE/thiazide group, the ACE/CCB group had a significantly lower rate of fatal and nonfatal myocardial infarction (2.2% vs 2.8%; HR, 0.78; 95% CI, 0.62–0.99; P = .04) and a lower rate of death from cardiovascular causes (1.9% vs 2.3%; HR, 0.80; 95% CI, 0.62–1.03, P = .08).

Worldwide, approximately 1 billion adults have a SBP ≥140 mm Hg.¹³ In the United States, 32% of adult women have Stage 2 hypertension or are taking an antihypertensive medication (TABLE).¹ There is a generally linear relationship between increasing SBP and DBP and an increased risk of a cardiovascular event, including heart failure, myocardial infarction, and stroke. An increase of SBP of 20 mm Hg or DBP of 10 mm Hg above a baseline BP of 115/75 mm Hg doubles the risk of death from CVD.¹⁴ For adults at risk for CVD, intensive treatment of hypertension clearly reduces the risk of a life-changing cardiovascular event.

It will probably take many years for the new SBP target of <120 mm Hg to be fully accepted by clinicians and patients because, although achieving a SBP of <120 mm Hg will decrease cardiovascular events, it is a very difficult target to achieve, requiring treatment with 3 antihypertensive medications for most patients. The early diagnosis and intensive treatment of hypertension is challenging because it requires clinicians to initiate a multi-decade course of treatment of asymptomatic people with the goal of preventing a life-altering cardiovascular event, including stroke and myocardial infarction.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

For many years, the approach to the diagnosis of hypertension was straight-forward—multiple blood pressure (BP) measurements ≥140/90 mm Hg established the diagnosis of hypertension, a disease associated with an increased risk of adverse cardiovascular events, including myocardial infarction and stroke. For more than a decade, hypertension experts have argued that a BP ≥130/80 mm Hg should establish the diagnosis of hypertension. Many clinicians resisted the change because it would markedly increase the number of asymptomatic adults with the diagnosis, increasing the number needing treatment. However, the findings of the Systolic Blood Pressure Intervention Trial (SPRINT) and other observational studies have catalyzed the American College of Cardiology (ACC) and the American Heart Association (AHA) to redefine normal BP as <120/80 mm Hg.¹ This change will expand the diagnosis of hypertension to include up to 50% of American adults.¹ In addition, the new definition of normal BP will result in the greater use of lifestyle interventions and antihypertensive medications to achieve the new normal, a BP of <120/80 mm Hg.

The new definition of hypertension

The new definition of hypertension is of particular importance for people at risk for developing cardiovascular disease (CVD) ^1,2 and is summarized here.

• Normal BP: systolic BP (SBP) <120 mm Hg and diastolic BP (DBP) <80 mm Hg
• Elevated BP: SBP 120–129 mm Hg and DBP <80 mm Hg
• Stage 1 hypertension: SBP 130–139 mm Hg or DBP 80–89 mm Hg.
• Stage 2 hypertension: SBP ≥140 mm Hg or DBP ≥90 mm Hg.

The new definition of hypertension will markedly increase the number of mid-life adults eligible to be treated for hypertension. I summarize the approach to treating hypertension in this article.

For mid-life adults, a SBP of <120 mm Hg is better for the heart
The heart is a pump, and not surprisingly, if a pump can achieve its job at a lower rather than a higher pressure, it is likely to last longer. The SPRINT study clearly demonstrated that in elderly hypertensive adults, an SBP target of <120 mm Hg is associated with fewer deaths than a SBP in the range of 130 to 140 mm Hg.³

In the SPRINT trial, 9,361 people with a mean age, body mass index, and BP of 68 years, 30 kg/m² and 140/78 mm Hg, respectively, were randomly assigned to intensive treatment of SBP to a goal of <120 mm Hg or to a target of <140 mm Hg. After 1 year of treatment, the intensive treatment group had a mean SBP of 121 mm Hg and the standard treatment group had a mean SBP of 136 mm Hg. To achieve a SBP <120 mm Hg, most patients required 3 antihypertensive medications, in contrast to the 2 antihypertensive medications typically needed to achieve a SBP in the range of 130 to 140 mm Hg.

After a median of 3.3 years of follow-up, significantly fewer deaths occurred in the intensive treatment group than in the standard treatment group, including deaths from all causes (3.3% vs 4.5%, P = .003) and deaths from CVD (0.8% vs 1.4%; P = .005). In addition, the risk of developing heart failure was lower in the intensive treatment than in the standard treatment group (1.3% vs 2.1%, P = .002). There was no difference between the 2 groups in the risk of stroke (1.3% vs 1.5%, P = .50) or myocardial infarction (2.1% vs 2.5%, P = .19). The rate of syncope was higher in the intensive treatment group (2.3% vs 1.7% in the standard treatment group, P = .05).³ Self-reported mental and physical health and satisfaction with treatment was similar in both groups.⁴

The investigators concluded that among people at risk for CVD, targeting a SBP of <120 mm Hg as compared to <140 mm Hg resulted in lower rates of heart failure and death, two clinically meaningful endpoints.

Read about nonpharmacologic interventions and antihypertensive medications to treat hypertension.

Diet and exercise

Nonpharmacologic interventions, including diet and exercise, are recommended for all people with a BP >120/80 mm Hg. In most situations, antihypertensive medications are not necessary if the patient has elevated BP (SBP 120–129 mm Hg and DBP <80 mm Hg) or Stage 1 hypertension (SBP 130–139 mm Hg or DBP 80–89 mm Hg) and a 10-year CVD risk of less than 10% using the ACC/AHA cardiovascular risk calculator⁵ (see http://www.cvriskcalcula tor.com/). For people at low risk for CVD, nonpharmacologic interventions, including diet and exercise, are often sufficient treatment.

The Dietary Approaches to Stop Hypertension (DASH) diet emphasizes increasing consumption of fruits, vegetables, low-fat dairy, whole-grains, fish, poultry, and nuts and decreasing the consumption of red meats, sugary drinks, sweets, sodium, and saturated and trans-fats. In randomized trials, the DASH diet is associated with a reduction in BP of approximately 5 mm Hg systolic and 3 mm Hg diastolic.⁶ The DASH trial monitored weight changes and adjusted calorie intake to ensure a stabilized weight throughout the study. Hence, the positive effect of the DASH diet was observed in the absence of any weight loss. Weight loss also can decrease BP with every 1- to 2-lb weight loss, reducing SBP by approximately 1 mm Hg.⁷ Combining the DASH diet with a low-sodium diet is especially important in people with high sodium intake, and is reported to reduce SBP by 5 to 20 mm Hg.⁸ Reducing the consumption of alcohol can result in a reduction of SBP and DBP in the range of 3 and 2 mm Hg, respectively.⁹

Exercising for 40 minutes, 3 to 4 times per week is associated with a reduction of SBP and DBP of approximately 5 and 3 mm Hg, respectively.¹⁰ Although the studies are of low quality, meditation is reported to decrease SBP and DBP by 4 and 2 mm Hg, respectively.¹¹

Antihypertensive medications

For all mid-life adults with Stage 2hypertension (SBP ≥140 mm Hg or DBP ≥90 mm Hg) or with both clinical CVD and Stage 1 hypertension, antihypertensive medications are recommended.¹ For people with Stage 1 hypertension and a 10-year CVD risk of ≥10%, antihypertensive medications are recommended. The target BP is <130/80 mm Hg for most people.

The recommended antihypertensive medications include thiazide diuretics, calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, and angiotensin II receptor blockers (ARBs). Many patients with Stage 2 hypertension will need treatment with 2 agents of different classes to achieve a BP <130/80 mm Hg. Some experts believe that an optimal 2-agent regimen includes an ACE or ARB plus a CCB based on the results of the ACCOMPLISH trial.¹² In this trial, 11,506 adults with hypertension and at very high risk for CVD, were randomly assigned to treatment with an ACE inhibitor plus CCB or with an ACE inhibitor plus hydrochlorothiazide. The BP achieved in both groups was approximately 132/73 mm Hg. The study was stopped after 3 years because participants in the ACE/thiazide group had a higher rate of adverse cardiovascular events (myocardial infarction, stroke, or death) than those in the ACE/CCB group (11.8% vs 9.6%; hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.72–0.90; P<.001). Compared to the ACE/thiazide group, the ACE/CCB group had a significantly lower rate of fatal and nonfatal myocardial infarction (2.2% vs 2.8%; HR, 0.78; 95% CI, 0.62–0.99; P = .04) and a lower rate of death from cardiovascular causes (1.9% vs 2.3%; HR, 0.80; 95% CI, 0.62–1.03, P = .08).

Worldwide, approximately 1 billion adults have a SBP ≥140 mm Hg.¹³ In the United States, 32% of adult women have Stage 2 hypertension or are taking an antihypertensive medication (TABLE).¹ There is a generally linear relationship between increasing SBP and DBP and an increased risk of a cardiovascular event, including heart failure, myocardial infarction, and stroke. An increase of SBP of 20 mm Hg or DBP of 10 mm Hg above a baseline BP of 115/75 mm Hg doubles the risk of death from CVD.¹⁴ For adults at risk for CVD, intensive treatment of hypertension clearly reduces the risk of a life-changing cardiovascular event.

It will probably take many years for the new SBP target of <120 mm Hg to be fully accepted by clinicians and patients because, although achieving a SBP of <120 mm Hg will decrease cardiovascular events, it is a very difficult target to achieve, requiring treatment with 3 antihypertensive medications for most patients. The early diagnosis and intensive treatment of hypertension is challenging because it requires clinicians to initiate a multi-decade course of treatment of asymptomatic people with the goal of preventing a life-altering cardiovascular event, including stroke and myocardial infarction.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

For many years, the approach to the diagnosis of hypertension was straight-forward—multiple blood pressure (BP) measurements ≥140/90 mm Hg established the diagnosis of hypertension, a disease associated with an increased risk of adverse cardiovascular events, including myocardial infarction and stroke. For more than a decade, hypertension experts have argued that a BP ≥130/80 mm Hg should establish the diagnosis of hypertension. Many clinicians resisted the change because it would markedly increase the number of asymptomatic adults with the diagnosis, increasing the number needing treatment. However, the findings of the Systolic Blood Pressure Intervention Trial (SPRINT) and other observational studies have catalyzed the American College of Cardiology (ACC) and the American Heart Association (AHA) to redefine normal BP as <120/80 mm Hg.¹ This change will expand the diagnosis of hypertension to include up to 50% of American adults.¹ In addition, the new definition of normal BP will result in the greater use of lifestyle interventions and antihypertensive medications to achieve the new normal, a BP of <120/80 mm Hg.

The new definition of hypertension

The new definition of hypertension is of particular importance for people at risk for developing cardiovascular disease (CVD) ^1,2 and is summarized here.

• Normal BP: systolic BP (SBP) <120 mm Hg and diastolic BP (DBP) <80 mm Hg
• Elevated BP: SBP 120–129 mm Hg and DBP <80 mm Hg
• Stage 1 hypertension: SBP 130–139 mm Hg or DBP 80–89 mm Hg.
• Stage 2 hypertension: SBP ≥140 mm Hg or DBP ≥90 mm Hg.

The new definition of hypertension will markedly increase the number of mid-life adults eligible to be treated for hypertension. I summarize the approach to treating hypertension in this article.

For mid-life adults, a SBP of <120 mm Hg is better for the heart
The heart is a pump, and not surprisingly, if a pump can achieve its job at a lower rather than a higher pressure, it is likely to last longer. The SPRINT study clearly demonstrated that in elderly hypertensive adults, an SBP target of <120 mm Hg is associated with fewer deaths than a SBP in the range of 130 to 140 mm Hg.³

In the SPRINT trial, 9,361 people with a mean age, body mass index, and BP of 68 years, 30 kg/m² and 140/78 mm Hg, respectively, were randomly assigned to intensive treatment of SBP to a goal of <120 mm Hg or to a target of <140 mm Hg. After 1 year of treatment, the intensive treatment group had a mean SBP of 121 mm Hg and the standard treatment group had a mean SBP of 136 mm Hg. To achieve a SBP <120 mm Hg, most patients required 3 antihypertensive medications, in contrast to the 2 antihypertensive medications typically needed to achieve a SBP in the range of 130 to 140 mm Hg.

After a median of 3.3 years of follow-up, significantly fewer deaths occurred in the intensive treatment group than in the standard treatment group, including deaths from all causes (3.3% vs 4.5%, P = .003) and deaths from CVD (0.8% vs 1.4%; P = .005). In addition, the risk of developing heart failure was lower in the intensive treatment than in the standard treatment group (1.3% vs 2.1%, P = .002). There was no difference between the 2 groups in the risk of stroke (1.3% vs 1.5%, P = .50) or myocardial infarction (2.1% vs 2.5%, P = .19). The rate of syncope was higher in the intensive treatment group (2.3% vs 1.7% in the standard treatment group, P = .05).³ Self-reported mental and physical health and satisfaction with treatment was similar in both groups.⁴

The investigators concluded that among people at risk for CVD, targeting a SBP of <120 mm Hg as compared to <140 mm Hg resulted in lower rates of heart failure and death, two clinically meaningful endpoints.

Read about nonpharmacologic interventions and antihypertensive medications to treat hypertension.

Diet and exercise

Nonpharmacologic interventions, including diet and exercise, are recommended for all people with a BP >120/80 mm Hg. In most situations, antihypertensive medications are not necessary if the patient has elevated BP (SBP 120–129 mm Hg and DBP <80 mm Hg) or Stage 1 hypertension (SBP 130–139 mm Hg or DBP 80–89 mm Hg) and a 10-year CVD risk of less than 10% using the ACC/AHA cardiovascular risk calculator⁵ (see http://www.cvriskcalcula tor.com/). For people at low risk for CVD, nonpharmacologic interventions, including diet and exercise, are often sufficient treatment.

The Dietary Approaches to Stop Hypertension (DASH) diet emphasizes increasing consumption of fruits, vegetables, low-fat dairy, whole-grains, fish, poultry, and nuts and decreasing the consumption of red meats, sugary drinks, sweets, sodium, and saturated and trans-fats. In randomized trials, the DASH diet is associated with a reduction in BP of approximately 5 mm Hg systolic and 3 mm Hg diastolic.⁶ The DASH trial monitored weight changes and adjusted calorie intake to ensure a stabilized weight throughout the study. Hence, the positive effect of the DASH diet was observed in the absence of any weight loss. Weight loss also can decrease BP with every 1- to 2-lb weight loss, reducing SBP by approximately 1 mm Hg.⁷ Combining the DASH diet with a low-sodium diet is especially important in people with high sodium intake, and is reported to reduce SBP by 5 to 20 mm Hg.⁸ Reducing the consumption of alcohol can result in a reduction of SBP and DBP in the range of 3 and 2 mm Hg, respectively.⁹

Exercising for 40 minutes, 3 to 4 times per week is associated with a reduction of SBP and DBP of approximately 5 and 3 mm Hg, respectively.¹⁰ Although the studies are of low quality, meditation is reported to decrease SBP and DBP by 4 and 2 mm Hg, respectively.¹¹

Antihypertensive medications

For all mid-life adults with Stage 2hypertension (SBP ≥140 mm Hg or DBP ≥90 mm Hg) or with both clinical CVD and Stage 1 hypertension, antihypertensive medications are recommended.¹ For people with Stage 1 hypertension and a 10-year CVD risk of ≥10%, antihypertensive medications are recommended. The target BP is <130/80 mm Hg for most people.

The recommended antihypertensive medications include thiazide diuretics, calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, and angiotensin II receptor blockers (ARBs). Many patients with Stage 2 hypertension will need treatment with 2 agents of different classes to achieve a BP <130/80 mm Hg. Some experts believe that an optimal 2-agent regimen includes an ACE or ARB plus a CCB based on the results of the ACCOMPLISH trial.¹² In this trial, 11,506 adults with hypertension and at very high risk for CVD, were randomly assigned to treatment with an ACE inhibitor plus CCB or with an ACE inhibitor plus hydrochlorothiazide. The BP achieved in both groups was approximately 132/73 mm Hg. The study was stopped after 3 years because participants in the ACE/thiazide group had a higher rate of adverse cardiovascular events (myocardial infarction, stroke, or death) than those in the ACE/CCB group (11.8% vs 9.6%; hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.72–0.90; P<.001). Compared to the ACE/thiazide group, the ACE/CCB group had a significantly lower rate of fatal and nonfatal myocardial infarction (2.2% vs 2.8%; HR, 0.78; 95% CI, 0.62–0.99; P = .04) and a lower rate of death from cardiovascular causes (1.9% vs 2.3%; HR, 0.80; 95% CI, 0.62–1.03, P = .08).

Worldwide, approximately 1 billion adults have a SBP ≥140 mm Hg.¹³ In the United States, 32% of adult women have Stage 2 hypertension or are taking an antihypertensive medication (TABLE).¹ There is a generally linear relationship between increasing SBP and DBP and an increased risk of a cardiovascular event, including heart failure, myocardial infarction, and stroke. An increase of SBP of 20 mm Hg or DBP of 10 mm Hg above a baseline BP of 115/75 mm Hg doubles the risk of death from CVD.¹⁴ For adults at risk for CVD, intensive treatment of hypertension clearly reduces the risk of a life-changing cardiovascular event.

It will probably take many years for the new SBP target of <120 mm Hg to be fully accepted by clinicians and patients because, although achieving a SBP of <120 mm Hg will decrease cardiovascular events, it is a very difficult target to achieve, requiring treatment with 3 antihypertensive medications for most patients. The early diagnosis and intensive treatment of hypertension is challenging because it requires clinicians to initiate a multi-decade course of treatment of asymptomatic people with the goal of preventing a life-altering cardiovascular event, including stroke and myocardial infarction.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Atrial fibrosis could be a key trigger for arrhythmia and stroke, how walnuts and the microbiome may cut cardiovascular risk, why some inflammatory bowel disease patients benefit by lighting up, and specialists warn Congress to protect Medicare Part B drug payments.

Listen to the MDedge Daily News podcast for all the details on today’s top news.

Atrial fibrosis could be a key trigger for arrhythmia and stroke, how walnuts and the microbiome may cut cardiovascular risk, why some inflammatory bowel disease patients benefit by lighting up, and specialists warn Congress to protect Medicare Part B drug payments.

Listen to the MDedge Daily News podcast for all the details on today’s top news.

Atrial fibrosis could be a key trigger for arrhythmia and stroke, how walnuts and the microbiome may cut cardiovascular risk, why some inflammatory bowel disease patients benefit by lighting up, and specialists warn Congress to protect Medicare Part B drug payments.

Listen to the MDedge Daily News podcast for all the details on today’s top news.

A series of National Institute of Health (NIH) clinical trials are bringing Zika virus vaccines closer to the public.

According to preliminary findings from 3 phase 1 clinical trials, an investigational Zika purified inactivated virus (ZPIV) vaccine was well tolerated and induced an immune response. Scientists from Walter Reed Army Institute of Research are developing the vaccine and leading 1 of the trials.

Of 67 adult participants, 55 received the investigational vaccine; 12 received placebo. All participants received 2 intramuscular injections 4 weeks apart. The researchers detected antibodies in > 90% of those who received the vaccine, 4 weeks after the last dose.

In phase 2 clinical trials, 2 versions of an experimental gene-based Zika vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases, were both found to be safe and to induce an immune response. One candidate showed “the most promise,” paving the way for an international phase 2/2b safety and efficacy trial, which began in 2017 and will last for 2 years.

“This trial marks a significant milestone in our efforts to develop countermeasures for a pandemic in progress,” said Anthony Fauci, MD, NIAID director

A series of National Institute of Health (NIH) clinical trials are bringing Zika virus vaccines closer to the public.

According to preliminary findings from 3 phase 1 clinical trials, an investigational Zika purified inactivated virus (ZPIV) vaccine was well tolerated and induced an immune response. Scientists from Walter Reed Army Institute of Research are developing the vaccine and leading 1 of the trials.

Of 67 adult participants, 55 received the investigational vaccine; 12 received placebo. All participants received 2 intramuscular injections 4 weeks apart. The researchers detected antibodies in > 90% of those who received the vaccine, 4 weeks after the last dose.

In phase 2 clinical trials, 2 versions of an experimental gene-based Zika vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases, were both found to be safe and to induce an immune response. One candidate showed “the most promise,” paving the way for an international phase 2/2b safety and efficacy trial, which began in 2017 and will last for 2 years.

“This trial marks a significant milestone in our efforts to develop countermeasures for a pandemic in progress,” said Anthony Fauci, MD, NIAID director

A series of National Institute of Health (NIH) clinical trials are bringing Zika virus vaccines closer to the public.

According to preliminary findings from 3 phase 1 clinical trials, an investigational Zika purified inactivated virus (ZPIV) vaccine was well tolerated and induced an immune response. Scientists from Walter Reed Army Institute of Research are developing the vaccine and leading 1 of the trials.

Of 67 adult participants, 55 received the investigational vaccine; 12 received placebo. All participants received 2 intramuscular injections 4 weeks apart. The researchers detected antibodies in > 90% of those who received the vaccine, 4 weeks after the last dose.

In phase 2 clinical trials, 2 versions of an experimental gene-based Zika vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases, were both found to be safe and to induce an immune response. One candidate showed “the most promise,” paving the way for an international phase 2/2b safety and efficacy trial, which began in 2017 and will last for 2 years.

“This trial marks a significant milestone in our efforts to develop countermeasures for a pandemic in progress,” said Anthony Fauci, MD, NIAID director

Mayo Clinic Proceedings

Intravenous (IV) bevacizumab “dramatically” improves severe bleeding associated with hereditary hemorrhagic telangiectasia (HHT), according to researchers.

In a retrospective study, HHT patients with severe bleeding had a substantial reduction in nose bleeds and gastrointestinal (GI) bleeding after treatment with IV bevacizumab.

In addition, patients were able to stop or considerably reduce red blood cell (RBC) transfusions.

The researchers therefore believe that IV bevacizumab should be considered as a first-line therapy for the treatment of refractory bleeding in patients with severe HHT.

The team detailed this research and in Mayo Clinic Proceedings alongside a related editorial.

“Some HHT patients suffer from severe epistaxis and gastrointestinal bleeding, which can result in severe anemia and years of blood transfusions,” said study author Vivek N. Iyer, MD, of the Mayo Clinic in Rochester, Minnesota.

“Both problems also appear to sometimes worsen with age. In some patients, both epistaxis and GI bleeding can become refractory/resistant to existing treatment options, leaving patients severely anemic and dependent on iron infusions or blood transfusions. Quality of life is very poor in these cases.”

With this in mind, Dr Iyer and his colleagues analyzed the records of 34 patients who were treated with IV bevacizumab for severe HHT-related bleeding from June 2013 through January 2017.

Patient characteristics

Patients had a median age of 63 (range, 57 to 72). Sixty-two percent of patients were female.

The primary source of bleeding was epistaxis in 15 patients, GI bleeding in 4 patients, and combined epistaxis and GI bleeding in 15 patients.

Prior epistaxis treatments included potassium-titanyl-phosphate/other laser procedures (62%), sclerotherapy (26%), endovascular angiographic embolization (21%), septodermoplasty (24%), subcutaneous bevacizumab injections (21%), and bevacizumab nasal spray (29%).

Seventy-one percent of patients underwent upper endoscopy (100% of these with telangiectasias), and 53% underwent colonoscopy (56% of these with telangiectasias).

Forty-one percent of patients had IV iron supplementation in the past 6 months.

Twenty-eight patients had received RBC transfusions. Sixteen patients were transfusion-dependent and had received a median of 75 transfusions before starting treatment with bevacizumab. The median duration of transfusion dependence was 6 years.

Treatment

The typical initial dosing cycle of bevacizumab consisted of 8 doses (4 doses each administered 2 weeks apart, followed by 4 doses each administered 1 month apart) over a period of around 22 weeks.

Further maintenance doses after the initial dosing cycle were individualized in each patient.

At last follow-up, 3 patients were still receiving bevacizumab from the initial dosing protocol. For the 31 patients who had completed the first dosing cycle, the median duration of follow-up was 13.6 months.

Eighteen patients required at least 1 top-up dose of IV bevacizumab because of worsening bleeding and/or anemia.

Efficacy

The median follow-up was 17.6 months (range, 3 to 42.5 months).

An Epistaxis Severity Score (ESS) questionnaire was used to assess the severity of nose bleeds both at the beginning of the study and after starting bevacizumab.

One month after starting treatment, there was a significant reduction in ESS scores (P<0.001). This improvement was maintained after patients completed the initial treatment cycle.

The median ESS score was 6.5 at baseline, 3.3 at 1 month, 4.0 at 3 months, 2.3 at the end of the first cycle, 2.0 at 1 to 3 months after the first cycle, 3.2 at 4 to 6 months, and 2.8 at 7 to 12 months.

GI bleeding also improved, with resolution or improvement of anemia in all 19 patients with this condition.

There was a reduction in RBC transfusions as well. The proportion of patients receiving transfusions was 53% in the 6 months before IV bevacizumab, 15% in the 1 to 3 months after starting IV bevacizumab, 14% at 4 to 6 months, 8% at 7 to 9 months, and 9% at 9 to 12 months.

Eighty-eight percent (n=14) of the transfusion-dependent patients had received a transfusion in the 6 months prior to starting IV bevacizumab. This compares to 31% (n=5) of patients in the 1 to 3 months after the start of treatment, 29% (n=4) at 4 to 6 months, 14% (n=2) at 7 to 9 months, and 8% (n=1) at 9 to 12 months.

Safety

Four patients had hypertension (HTN). One had pre-existing HTN and had to double the daily dose of lisinopril from 10 mg to 20 mg.

Two HTN patients had to start antihypertensive medications. The fourth patient experienced hypertensive urgency with a temporary decline in renal function. However, the patient was able to resume bevacizumab.

Two patients had infusion-related chills and fever, but premedication with acetaminophen and diphenhydramine prevented these events from recurring.

Three patients died during follow-up. Causes of death were stroke, infective endocarditis (methicillin-sensitive Staphylococcus aureus) with multiple cerebral infarcts, and postoperative respiratory failure (after left atrial appendectomy for paroxysmal atrial fibrillation).

None of these deaths were directly linked to bevacizumab.

“This study provides good-quality evidence for the excellent efficacy and safety of intravenous bevacizumab in the treatment of these patients,” Dr Iyer said. “Intravenous bevacizumab should be considered as a standard, first-line treatment option for HHT patients with severe bleeding and transfusion-dependent anemia.”

Mayo Clinic Proceedings

Intravenous (IV) bevacizumab “dramatically” improves severe bleeding associated with hereditary hemorrhagic telangiectasia (HHT), according to researchers.

In a retrospective study, HHT patients with severe bleeding had a substantial reduction in nose bleeds and gastrointestinal (GI) bleeding after treatment with IV bevacizumab.

In addition, patients were able to stop or considerably reduce red blood cell (RBC) transfusions.

The researchers therefore believe that IV bevacizumab should be considered as a first-line therapy for the treatment of refractory bleeding in patients with severe HHT.

The team detailed this research and in Mayo Clinic Proceedings alongside a related editorial.

“Some HHT patients suffer from severe epistaxis and gastrointestinal bleeding, which can result in severe anemia and years of blood transfusions,” said study author Vivek N. Iyer, MD, of the Mayo Clinic in Rochester, Minnesota.

“Both problems also appear to sometimes worsen with age. In some patients, both epistaxis and GI bleeding can become refractory/resistant to existing treatment options, leaving patients severely anemic and dependent on iron infusions or blood transfusions. Quality of life is very poor in these cases.”

With this in mind, Dr Iyer and his colleagues analyzed the records of 34 patients who were treated with IV bevacizumab for severe HHT-related bleeding from June 2013 through January 2017.

Patient characteristics

Patients had a median age of 63 (range, 57 to 72). Sixty-two percent of patients were female.

The primary source of bleeding was epistaxis in 15 patients, GI bleeding in 4 patients, and combined epistaxis and GI bleeding in 15 patients.

Prior epistaxis treatments included potassium-titanyl-phosphate/other laser procedures (62%), sclerotherapy (26%), endovascular angiographic embolization (21%), septodermoplasty (24%), subcutaneous bevacizumab injections (21%), and bevacizumab nasal spray (29%).

Seventy-one percent of patients underwent upper endoscopy (100% of these with telangiectasias), and 53% underwent colonoscopy (56% of these with telangiectasias).

Forty-one percent of patients had IV iron supplementation in the past 6 months.

Twenty-eight patients had received RBC transfusions. Sixteen patients were transfusion-dependent and had received a median of 75 transfusions before starting treatment with bevacizumab. The median duration of transfusion dependence was 6 years.

Treatment

The typical initial dosing cycle of bevacizumab consisted of 8 doses (4 doses each administered 2 weeks apart, followed by 4 doses each administered 1 month apart) over a period of around 22 weeks.

Further maintenance doses after the initial dosing cycle were individualized in each patient.

At last follow-up, 3 patients were still receiving bevacizumab from the initial dosing protocol. For the 31 patients who had completed the first dosing cycle, the median duration of follow-up was 13.6 months.

Eighteen patients required at least 1 top-up dose of IV bevacizumab because of worsening bleeding and/or anemia.

Efficacy

The median follow-up was 17.6 months (range, 3 to 42.5 months).

An Epistaxis Severity Score (ESS) questionnaire was used to assess the severity of nose bleeds both at the beginning of the study and after starting bevacizumab.

One month after starting treatment, there was a significant reduction in ESS scores (P<0.001). This improvement was maintained after patients completed the initial treatment cycle.

The median ESS score was 6.5 at baseline, 3.3 at 1 month, 4.0 at 3 months, 2.3 at the end of the first cycle, 2.0 at 1 to 3 months after the first cycle, 3.2 at 4 to 6 months, and 2.8 at 7 to 12 months.

GI bleeding also improved, with resolution or improvement of anemia in all 19 patients with this condition.

There was a reduction in RBC transfusions as well. The proportion of patients receiving transfusions was 53% in the 6 months before IV bevacizumab, 15% in the 1 to 3 months after starting IV bevacizumab, 14% at 4 to 6 months, 8% at 7 to 9 months, and 9% at 9 to 12 months.

Eighty-eight percent (n=14) of the transfusion-dependent patients had received a transfusion in the 6 months prior to starting IV bevacizumab. This compares to 31% (n=5) of patients in the 1 to 3 months after the start of treatment, 29% (n=4) at 4 to 6 months, 14% (n=2) at 7 to 9 months, and 8% (n=1) at 9 to 12 months.

Safety

Four patients had hypertension (HTN). One had pre-existing HTN and had to double the daily dose of lisinopril from 10 mg to 20 mg.

Two HTN patients had to start antihypertensive medications. The fourth patient experienced hypertensive urgency with a temporary decline in renal function. However, the patient was able to resume bevacizumab.

Two patients had infusion-related chills and fever, but premedication with acetaminophen and diphenhydramine prevented these events from recurring.

Three patients died during follow-up. Causes of death were stroke, infective endocarditis (methicillin-sensitive Staphylococcus aureus) with multiple cerebral infarcts, and postoperative respiratory failure (after left atrial appendectomy for paroxysmal atrial fibrillation).

None of these deaths were directly linked to bevacizumab.

“This study provides good-quality evidence for the excellent efficacy and safety of intravenous bevacizumab in the treatment of these patients,” Dr Iyer said. “Intravenous bevacizumab should be considered as a standard, first-line treatment option for HHT patients with severe bleeding and transfusion-dependent anemia.”

Mayo Clinic Proceedings

Intravenous (IV) bevacizumab “dramatically” improves severe bleeding associated with hereditary hemorrhagic telangiectasia (HHT), according to researchers.

In a retrospective study, HHT patients with severe bleeding had a substantial reduction in nose bleeds and gastrointestinal (GI) bleeding after treatment with IV bevacizumab.

In addition, patients were able to stop or considerably reduce red blood cell (RBC) transfusions.

The researchers therefore believe that IV bevacizumab should be considered as a first-line therapy for the treatment of refractory bleeding in patients with severe HHT.

The team detailed this research and in Mayo Clinic Proceedings alongside a related editorial.

“Some HHT patients suffer from severe epistaxis and gastrointestinal bleeding, which can result in severe anemia and years of blood transfusions,” said study author Vivek N. Iyer, MD, of the Mayo Clinic in Rochester, Minnesota.

“Both problems also appear to sometimes worsen with age. In some patients, both epistaxis and GI bleeding can become refractory/resistant to existing treatment options, leaving patients severely anemic and dependent on iron infusions or blood transfusions. Quality of life is very poor in these cases.”

With this in mind, Dr Iyer and his colleagues analyzed the records of 34 patients who were treated with IV bevacizumab for severe HHT-related bleeding from June 2013 through January 2017.

Patient characteristics

Patients had a median age of 63 (range, 57 to 72). Sixty-two percent of patients were female.

The primary source of bleeding was epistaxis in 15 patients, GI bleeding in 4 patients, and combined epistaxis and GI bleeding in 15 patients.

Prior epistaxis treatments included potassium-titanyl-phosphate/other laser procedures (62%), sclerotherapy (26%), endovascular angiographic embolization (21%), septodermoplasty (24%), subcutaneous bevacizumab injections (21%), and bevacizumab nasal spray (29%).

Seventy-one percent of patients underwent upper endoscopy (100% of these with telangiectasias), and 53% underwent colonoscopy (56% of these with telangiectasias).

Forty-one percent of patients had IV iron supplementation in the past 6 months.

Twenty-eight patients had received RBC transfusions. Sixteen patients were transfusion-dependent and had received a median of 75 transfusions before starting treatment with bevacizumab. The median duration of transfusion dependence was 6 years.

Treatment

The typical initial dosing cycle of bevacizumab consisted of 8 doses (4 doses each administered 2 weeks apart, followed by 4 doses each administered 1 month apart) over a period of around 22 weeks.

Further maintenance doses after the initial dosing cycle were individualized in each patient.

At last follow-up, 3 patients were still receiving bevacizumab from the initial dosing protocol. For the 31 patients who had completed the first dosing cycle, the median duration of follow-up was 13.6 months.

Eighteen patients required at least 1 top-up dose of IV bevacizumab because of worsening bleeding and/or anemia.

Efficacy

The median follow-up was 17.6 months (range, 3 to 42.5 months).

An Epistaxis Severity Score (ESS) questionnaire was used to assess the severity of nose bleeds both at the beginning of the study and after starting bevacizumab.

One month after starting treatment, there was a significant reduction in ESS scores (P<0.001). This improvement was maintained after patients completed the initial treatment cycle.

The median ESS score was 6.5 at baseline, 3.3 at 1 month, 4.0 at 3 months, 2.3 at the end of the first cycle, 2.0 at 1 to 3 months after the first cycle, 3.2 at 4 to 6 months, and 2.8 at 7 to 12 months.

GI bleeding also improved, with resolution or improvement of anemia in all 19 patients with this condition.

There was a reduction in RBC transfusions as well. The proportion of patients receiving transfusions was 53% in the 6 months before IV bevacizumab, 15% in the 1 to 3 months after starting IV bevacizumab, 14% at 4 to 6 months, 8% at 7 to 9 months, and 9% at 9 to 12 months.

Eighty-eight percent (n=14) of the transfusion-dependent patients had received a transfusion in the 6 months prior to starting IV bevacizumab. This compares to 31% (n=5) of patients in the 1 to 3 months after the start of treatment, 29% (n=4) at 4 to 6 months, 14% (n=2) at 7 to 9 months, and 8% (n=1) at 9 to 12 months.

Safety

Four patients had hypertension (HTN). One had pre-existing HTN and had to double the daily dose of lisinopril from 10 mg to 20 mg.

Two HTN patients had to start antihypertensive medications. The fourth patient experienced hypertensive urgency with a temporary decline in renal function. However, the patient was able to resume bevacizumab.

Two patients had infusion-related chills and fever, but premedication with acetaminophen and diphenhydramine prevented these events from recurring.

Three patients died during follow-up. Causes of death were stroke, infective endocarditis (methicillin-sensitive Staphylococcus aureus) with multiple cerebral infarcts, and postoperative respiratory failure (after left atrial appendectomy for paroxysmal atrial fibrillation).

None of these deaths were directly linked to bevacizumab.

“This study provides good-quality evidence for the excellent efficacy and safety of intravenous bevacizumab in the treatment of these patients,” Dr Iyer said. “Intravenous bevacizumab should be considered as a standard, first-line treatment option for HHT patients with severe bleeding and transfusion-dependent anemia.”

Photo by Esther Dyson

New research has revealed a lack of public information regarding protocols for industry-sponsored, randomized drug trials in Denmark.

First, researchers found it difficult to obtain protocols for commercially sponsored trials, with some sponsors taking legal action in an attempt to keep protocols private.

When the researchers did receive protocols, many had widespread redactions.

The researchers reported these findings in the Journal of the Royal Society of Medicine.

“We wished to compare the information in the protocols with the information provided to the patients in order to evaluate whether the trials were ethical and necessary and whether essential information about the benefits and the harms of the drugs had been hidden from the patients,” said study author Peter Gøtzsche, MD, director of the Nordic Cochrane Centre in Copenhagen, Denmark.

To that end, Dr Gøtzsche and his colleagues used the Danish Freedom of Information Act to request access to 78 protocols for randomized trials that were approved by a research ethics committee from October 2012 to March 2013.

The researchers said several companies refused to provide protocols and involved their lawyers. In fact, Sanofi-Aventis sued the National Committee on Health Research Ethics but lost.

Three years after this project was started, the researchers were able to obtain all the protocols they had requested. Eight protocols were excluded from analysis because they did not meet the research inclusion criteria.

Seventeen of 34 protocols for commercially sponsored trials were unredacted, compared to 34 of 36 non-commercially sponsored trials.

The researchers said the redactions “were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials.”

This includes data analysis, the handling of missing data, the detection/analysis of adverse events, the definition of patient outcomes, interim analyses and premature study termination, the sponsor’s access to incoming data while the study is ongoing, ownership of the data, and investigators’ publication rights.

“The amount of redactions in the protocols we received was so vast that it made them rather useless for assessing the ethical justification for the studies and to identify discrepancies with subsequent publications,” Dr Gøtzsche said.

“We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.”

Photo by Esther Dyson

New research has revealed a lack of public information regarding protocols for industry-sponsored, randomized drug trials in Denmark.

First, researchers found it difficult to obtain protocols for commercially sponsored trials, with some sponsors taking legal action in an attempt to keep protocols private.

When the researchers did receive protocols, many had widespread redactions.

The researchers reported these findings in the Journal of the Royal Society of Medicine.

“We wished to compare the information in the protocols with the information provided to the patients in order to evaluate whether the trials were ethical and necessary and whether essential information about the benefits and the harms of the drugs had been hidden from the patients,” said study author Peter Gøtzsche, MD, director of the Nordic Cochrane Centre in Copenhagen, Denmark.

To that end, Dr Gøtzsche and his colleagues used the Danish Freedom of Information Act to request access to 78 protocols for randomized trials that were approved by a research ethics committee from October 2012 to March 2013.

The researchers said several companies refused to provide protocols and involved their lawyers. In fact, Sanofi-Aventis sued the National Committee on Health Research Ethics but lost.

Three years after this project was started, the researchers were able to obtain all the protocols they had requested. Eight protocols were excluded from analysis because they did not meet the research inclusion criteria.

Seventeen of 34 protocols for commercially sponsored trials were unredacted, compared to 34 of 36 non-commercially sponsored trials.

The researchers said the redactions “were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials.”

This includes data analysis, the handling of missing data, the detection/analysis of adverse events, the definition of patient outcomes, interim analyses and premature study termination, the sponsor’s access to incoming data while the study is ongoing, ownership of the data, and investigators’ publication rights.

“The amount of redactions in the protocols we received was so vast that it made them rather useless for assessing the ethical justification for the studies and to identify discrepancies with subsequent publications,” Dr Gøtzsche said.

“We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.”

Photo by Esther Dyson

New research has revealed a lack of public information regarding protocols for industry-sponsored, randomized drug trials in Denmark.

First, researchers found it difficult to obtain protocols for commercially sponsored trials, with some sponsors taking legal action in an attempt to keep protocols private.

When the researchers did receive protocols, many had widespread redactions.

The researchers reported these findings in the Journal of the Royal Society of Medicine.

“We wished to compare the information in the protocols with the information provided to the patients in order to evaluate whether the trials were ethical and necessary and whether essential information about the benefits and the harms of the drugs had been hidden from the patients,” said study author Peter Gøtzsche, MD, director of the Nordic Cochrane Centre in Copenhagen, Denmark.

To that end, Dr Gøtzsche and his colleagues used the Danish Freedom of Information Act to request access to 78 protocols for randomized trials that were approved by a research ethics committee from October 2012 to March 2013.

The researchers said several companies refused to provide protocols and involved their lawyers. In fact, Sanofi-Aventis sued the National Committee on Health Research Ethics but lost.

Three years after this project was started, the researchers were able to obtain all the protocols they had requested. Eight protocols were excluded from analysis because they did not meet the research inclusion criteria.

Seventeen of 34 protocols for commercially sponsored trials were unredacted, compared to 34 of 36 non-commercially sponsored trials.

The researchers said the redactions “were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials.”

This includes data analysis, the handling of missing data, the detection/analysis of adverse events, the definition of patient outcomes, interim analyses and premature study termination, the sponsor’s access to incoming data while the study is ongoing, ownership of the data, and investigators’ publication rights.

“The amount of redactions in the protocols we received was so vast that it made them rather useless for assessing the ethical justification for the studies and to identify discrepancies with subsequent publications,” Dr Gøtzsche said.

“We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.”

Tsodikov, A., et al, Ann Intern Med 167(7):449, October 3, 2017

BACKGROUND: In 2012 the U.S. Preventive Services Task Force recommended against routine prostate cancer screening because its lack of effect on long-term mortality. Their recommendations (which are being updated) were based mainly on the ERSPC (European Randomized Study of Screening for Prostate Cancer) and PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) trials. However, these two trials are substantially different in terms of design, settings, screening intensity, baseline risk and screening effect on mortality (a relative reduction of 21% vs. no reduction, respectively).

METHODS: To evaluate whether the mortality difference persisted after accounting for implementation and practice setting differences, these multinational authors combined data from both trials to conduct a traditional statistical analysis that adjusted for participant age and trial setting, and extended analyses that overcame variability in screening intensity by considering mean lead times, which indicated increased prostate cancer incidence and earlier diagnosis with vs. without screening. Follow-up was restricted to eleven years for both trials.

RESULTS: The traditional analysis demonstrated a marginally different screening effect on mortality between trials (p=0.087), and an overall relative risk reduction of 16% (p=0.010). Extended analyses indicated no difference in screening effect on mortality between trials (p=0.37 to 0.47), and an overall association of longer mean lead times with a lower risk of prostate cancer specific death (p=0.0027 to 0.0032). Screening was estimated to lead to a 25-31% and a 27-32% relative reduction in risk of prostate cancer death in the two trials, respectively, vs. no screening (NNT = ~ 1,111 for 11 years of regular screening).

CONCLUSIONS: This analysis of data from two large prostate cancer-screening trials found that screening significantly reduced prostate cancer mortality risk compared with no screening. 18 references ([email protected] for reprints)

Tsodikov, A., et al, Ann Intern Med 167(7):449, October 3, 2017

BACKGROUND: In 2012 the U.S. Preventive Services Task Force recommended against routine prostate cancer screening because its lack of effect on long-term mortality. Their recommendations (which are being updated) were based mainly on the ERSPC (European Randomized Study of Screening for Prostate Cancer) and PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) trials. However, these two trials are substantially different in terms of design, settings, screening intensity, baseline risk and screening effect on mortality (a relative reduction of 21% vs. no reduction, respectively).

METHODS: To evaluate whether the mortality difference persisted after accounting for implementation and practice setting differences, these multinational authors combined data from both trials to conduct a traditional statistical analysis that adjusted for participant age and trial setting, and extended analyses that overcame variability in screening intensity by considering mean lead times, which indicated increased prostate cancer incidence and earlier diagnosis with vs. without screening. Follow-up was restricted to eleven years for both trials.

RESULTS: The traditional analysis demonstrated a marginally different screening effect on mortality between trials (p=0.087), and an overall relative risk reduction of 16% (p=0.010). Extended analyses indicated no difference in screening effect on mortality between trials (p=0.37 to 0.47), and an overall association of longer mean lead times with a lower risk of prostate cancer specific death (p=0.0027 to 0.0032). Screening was estimated to lead to a 25-31% and a 27-32% relative reduction in risk of prostate cancer death in the two trials, respectively, vs. no screening (NNT = ~ 1,111 for 11 years of regular screening).

CONCLUSIONS: This analysis of data from two large prostate cancer-screening trials found that screening significantly reduced prostate cancer mortality risk compared with no screening. 18 references ([email protected] for reprints)

Tsodikov, A., et al, Ann Intern Med 167(7):449, October 3, 2017

BACKGROUND: In 2012 the U.S. Preventive Services Task Force recommended against routine prostate cancer screening because its lack of effect on long-term mortality. Their recommendations (which are being updated) were based mainly on the ERSPC (European Randomized Study of Screening for Prostate Cancer) and PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) trials. However, these two trials are substantially different in terms of design, settings, screening intensity, baseline risk and screening effect on mortality (a relative reduction of 21% vs. no reduction, respectively).

METHODS: To evaluate whether the mortality difference persisted after accounting for implementation and practice setting differences, these multinational authors combined data from both trials to conduct a traditional statistical analysis that adjusted for participant age and trial setting, and extended analyses that overcame variability in screening intensity by considering mean lead times, which indicated increased prostate cancer incidence and earlier diagnosis with vs. without screening. Follow-up was restricted to eleven years for both trials.

RESULTS: The traditional analysis demonstrated a marginally different screening effect on mortality between trials (p=0.087), and an overall relative risk reduction of 16% (p=0.010). Extended analyses indicated no difference in screening effect on mortality between trials (p=0.37 to 0.47), and an overall association of longer mean lead times with a lower risk of prostate cancer specific death (p=0.0027 to 0.0032). Screening was estimated to lead to a 25-31% and a 27-32% relative reduction in risk of prostate cancer death in the two trials, respectively, vs. no screening (NNT = ~ 1,111 for 11 years of regular screening).

CONCLUSIONS: This analysis of data from two large prostate cancer-screening trials found that screening significantly reduced prostate cancer mortality risk compared with no screening. 18 references ([email protected] for reprints)

NEW YORK – About 25% of preadolescent children with attention-deficit/hyperactivity disorder have impulsive reactive aggression, a common but so far unnamed comorbidity that deserves attention and therapy, according to Robert L. Findling, MD.

Emphasizing the reactive component to this behavioral problem, he said: “They look okay until someone bumps into them at school. They do not have a mood disorder. They have a disorder of reactivity.”

Thinglass/Thinkstock

Dr. Findling reported financial ties with numerous pharmaceutical companies.

[email protected]

SOURCE: Findling RL. Psychopharmacology Update Institute

NEW YORK – About 25% of preadolescent children with attention-deficit/hyperactivity disorder have impulsive reactive aggression, a common but so far unnamed comorbidity that deserves attention and therapy, according to Robert L. Findling, MD.

Emphasizing the reactive component to this behavioral problem, he said: “They look okay until someone bumps into them at school. They do not have a mood disorder. They have a disorder of reactivity.”

Thinglass/Thinkstock

Dr. Findling reported financial ties with numerous pharmaceutical companies.

[email protected]

SOURCE: Findling RL. Psychopharmacology Update Institute

NEW YORK – About 25% of preadolescent children with attention-deficit/hyperactivity disorder have impulsive reactive aggression, a common but so far unnamed comorbidity that deserves attention and therapy, according to Robert L. Findling, MD.

Emphasizing the reactive component to this behavioral problem, he said: “They look okay until someone bumps into them at school. They do not have a mood disorder. They have a disorder of reactivity.”

Thinglass/Thinkstock

Dr. Findling reported financial ties with numerous pharmaceutical companies.

[email protected]

SOURCE: Findling RL. Psychopharmacology Update Institute

LAKE BUENA VISTA, FLA. – Every year brings new studies, updates, and trials, and it can be a challenge to keep up.

Christian Jones, MD, FACS, a general surgeon in the division of acute care surgery at Johns Hopkins University, Baltimore, ranked some of the more notable trauma studies published in the past year and presented his perspective on them at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

Day 2 is the “sweet spot” for cholecystectomy

When it comes to cholecystectomy, acute cholecystitis (AC) patients appear to fare the best when operations are conducted on day 2 after admission, according to a study of patients registered in the Swedish Registry of Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks).

The retrospective study of 15,760 AC patients found that the rate of 30-day mortality of AC patients was significantly higher for patients who underwent a cholecystectomy on day of (odds ratio = .42) 3 days after (OR = .34), and 4 days after admission (OR = 1.0), compared with those who were operated on between 1 day after (OR = .23), and 2 days after (OR = .29) admission.

Lead author My Blohm, MD, of the department of clinical sciences, intervention, and technology at the Karolinska Institutet, Stockholm, and fellow investigators hypothesized that waiting allows patients to be medically optimized for surgery (J Gastrointest Surg. 2017;21[1]: 33-40).

With 90-day mortality rates showing nearly identical results for day 1 and day 2, holding off on surgery may be the best move for the patient, even if it is not the ideal situation for a provider.

“Sure, as we all know by now, delayed cholecystectomy is seldom necessary, later surgery is more difficult, and more likely to be associated with complications at least with an equal conversion to an open procedure, but even more surprising is the higher mortality on the admissions day,” said Dr. Jones.

Antibiotics for abscess drainage patients

For patients requiring abscess drainage, antibiotics may be the best bet to keep infection at bay, according to a study published in the New England Journal of Medicine in June 2017.

The prospective, randomized, placebo-controlled, double-blind, study of 786 simple skin abscess drainage patients found clindamycin and Bactrim (sulfamethoxazole and trimethoprim) outperformed a placebo in an evaluation of symptoms of true ongoing infection in patients even 30 days after the procedure (N Engl J Med. 2017 Jun 29;376[26]:2545-55).

Patients studied had Staphylococcus aureus (527) or methicillin-resistant S. aureus (388).

After 10 days of therapy, cure rate of infection for the clindamycin and Bactrim groups were 83% and 82% respectively, compared with 70% in the placebo group, according to Robert S. Daum, MD, principal investigator at the MRSA Research Center, University of Chicago. After 30 days, cure rate for both antibiotic groups remained superior to that of the placebo group.

While these treatments were successful, concern of drug resistance is notable and should be taken into consideration when deciding on treatment options.

“This does get to our typical concern with increased antibiotic usage, and that’s the concern of the health of the community versus the health of the individual patient,” said Dr. Jones. “Is the increased rate of [antibiotic] resistance important enough to have a lower cure rate of simple abscess drainage? We don’t know the answer to that.”

Loop ileostomies look good for C. diff patients

This minimally invasive procedure has been the subject of some well-received studies with findings that indicate it is a promising choice for patients with a Clostridium difficile–associated disease (CDAD) over total colectomy, Dr. Jones said.

In a study published in the Journal of Trauma and Acute Care Surgery, a study group of patients with CDAD who had loop ileostomy had no statistical difference in almost any recorded characteristic compared with those who underwent a total colectomy, except mortality rate. The retrospective, multicenter study of 98 CDAD patients found the mortality rate of the loop ileostomy group to be 17.2%, compared with 39.7% in the total colectomy group (J Trauma Acute Care Surg. 2017 Jul;83[1]:36-40).

“The outcomes all favored loop ileostomy in a statistically significant fashion,” said Dr. Jones. “Unsurprisingly, estimated blood loss and need for transfusions were all significantly less in the loop ileostomy patients, and the adjusted overall mortality, even if requiring a reoperation, still favored doing the loop ileostomy first.”

The one difference between LI and colectomy patients was a longer time from initial diagnosis to operation among LI patients, with about 12 hours from diagnosis for the colectomy versus 24 hours for LI patients, according to lead author Paula Ferrada, MD, FACS, director of the surgical and trauma intensive care unit at Virginia Commonwealth University, Richmond, and her fellow investigators,

Contrary to previous findings, the study found that LI can be performed on sick patients as well, according to the researchers, and failure of the procedure is not associated with increased mortality.

While these findings are encouraging, “there are things that the individual patient may reveal to you on your examination that tell you they are not a candidate and that you should go to total colectomy,” said Dr. Jones. “Keep in mind that perhaps we can be a bit more aggressive in this less invasive procedure.”
 

The skin vac actually works

A study published in Annals of Surgery found prophylactic negative-pressure dressings are associated with a decreased rate of surgical site infections in laparotomy wounds.

“The biggest surprise to me out of all of these studies is that a new piece of technology actually seems to work,” said Dr. Jones.

The randomized study included 50 laparotomy patients with a stapled wound, half of whom received a skin vac over their incision while the other half had a standard OpSite occlusive dressing (Ann Surg. 2017 Jun;265[6]:1082-6).

Patients in both arms had the same type of wound and had their dressings on for 4 days before being switched.

Rate of surgical site infections for the skin vac group was 8.3% over 30 days from operation, compared with 32% in the OpSite group. Average length of stay for patients with the pressure dressing was 6.1 days, while patients with an OpSite dressing had a length of 14.7 days, more than double, according to lead author Donal Peter O’Leary, MD, surgeon at Cork University Hospital, Ireland.

The difference in length of stay does become insignificant if six OpSite patients who stayed longer than 20 days are discounted, only two of whom were delayed because of wound complications as opposed to placement issues or unassociated infections.

“But a surgical site infection difference of 50% or more using a skin vac instead of a standard dressing, whether you’re talking about clean, clean-contaminated, or contaminated cases with a skin closure, seems to be worthy of notice,” explained Dr. Jones.

[email protected]

LAKE BUENA VISTA, FLA. – Every year brings new studies, updates, and trials, and it can be a challenge to keep up.

Christian Jones, MD, FACS, a general surgeon in the division of acute care surgery at Johns Hopkins University, Baltimore, ranked some of the more notable trauma studies published in the past year and presented his perspective on them at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

Day 2 is the “sweet spot” for cholecystectomy

When it comes to cholecystectomy, acute cholecystitis (AC) patients appear to fare the best when operations are conducted on day 2 after admission, according to a study of patients registered in the Swedish Registry of Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks).

The retrospective study of 15,760 AC patients found that the rate of 30-day mortality of AC patients was significantly higher for patients who underwent a cholecystectomy on day of (odds ratio = .42) 3 days after (OR = .34), and 4 days after admission (OR = 1.0), compared with those who were operated on between 1 day after (OR = .23), and 2 days after (OR = .29) admission.

Lead author My Blohm, MD, of the department of clinical sciences, intervention, and technology at the Karolinska Institutet, Stockholm, and fellow investigators hypothesized that waiting allows patients to be medically optimized for surgery (J Gastrointest Surg. 2017;21[1]: 33-40).

With 90-day mortality rates showing nearly identical results for day 1 and day 2, holding off on surgery may be the best move for the patient, even if it is not the ideal situation for a provider.

“Sure, as we all know by now, delayed cholecystectomy is seldom necessary, later surgery is more difficult, and more likely to be associated with complications at least with an equal conversion to an open procedure, but even more surprising is the higher mortality on the admissions day,” said Dr. Jones.

Antibiotics for abscess drainage patients

For patients requiring abscess drainage, antibiotics may be the best bet to keep infection at bay, according to a study published in the New England Journal of Medicine in June 2017.

The prospective, randomized, placebo-controlled, double-blind, study of 786 simple skin abscess drainage patients found clindamycin and Bactrim (sulfamethoxazole and trimethoprim) outperformed a placebo in an evaluation of symptoms of true ongoing infection in patients even 30 days after the procedure (N Engl J Med. 2017 Jun 29;376[26]:2545-55).

Patients studied had Staphylococcus aureus (527) or methicillin-resistant S. aureus (388).

After 10 days of therapy, cure rate of infection for the clindamycin and Bactrim groups were 83% and 82% respectively, compared with 70% in the placebo group, according to Robert S. Daum, MD, principal investigator at the MRSA Research Center, University of Chicago. After 30 days, cure rate for both antibiotic groups remained superior to that of the placebo group.

While these treatments were successful, concern of drug resistance is notable and should be taken into consideration when deciding on treatment options.

“This does get to our typical concern with increased antibiotic usage, and that’s the concern of the health of the community versus the health of the individual patient,” said Dr. Jones. “Is the increased rate of [antibiotic] resistance important enough to have a lower cure rate of simple abscess drainage? We don’t know the answer to that.”

Loop ileostomies look good for C. diff patients

This minimally invasive procedure has been the subject of some well-received studies with findings that indicate it is a promising choice for patients with a Clostridium difficile–associated disease (CDAD) over total colectomy, Dr. Jones said.

In a study published in the Journal of Trauma and Acute Care Surgery, a study group of patients with CDAD who had loop ileostomy had no statistical difference in almost any recorded characteristic compared with those who underwent a total colectomy, except mortality rate. The retrospective, multicenter study of 98 CDAD patients found the mortality rate of the loop ileostomy group to be 17.2%, compared with 39.7% in the total colectomy group (J Trauma Acute Care Surg. 2017 Jul;83[1]:36-40).

“The outcomes all favored loop ileostomy in a statistically significant fashion,” said Dr. Jones. “Unsurprisingly, estimated blood loss and need for transfusions were all significantly less in the loop ileostomy patients, and the adjusted overall mortality, even if requiring a reoperation, still favored doing the loop ileostomy first.”

The one difference between LI and colectomy patients was a longer time from initial diagnosis to operation among LI patients, with about 12 hours from diagnosis for the colectomy versus 24 hours for LI patients, according to lead author Paula Ferrada, MD, FACS, director of the surgical and trauma intensive care unit at Virginia Commonwealth University, Richmond, and her fellow investigators,

Contrary to previous findings, the study found that LI can be performed on sick patients as well, according to the researchers, and failure of the procedure is not associated with increased mortality.

While these findings are encouraging, “there are things that the individual patient may reveal to you on your examination that tell you they are not a candidate and that you should go to total colectomy,” said Dr. Jones. “Keep in mind that perhaps we can be a bit more aggressive in this less invasive procedure.”
 

The skin vac actually works

A study published in Annals of Surgery found prophylactic negative-pressure dressings are associated with a decreased rate of surgical site infections in laparotomy wounds.

“The biggest surprise to me out of all of these studies is that a new piece of technology actually seems to work,” said Dr. Jones.

The randomized study included 50 laparotomy patients with a stapled wound, half of whom received a skin vac over their incision while the other half had a standard OpSite occlusive dressing (Ann Surg. 2017 Jun;265[6]:1082-6).

Patients in both arms had the same type of wound and had their dressings on for 4 days before being switched.

Rate of surgical site infections for the skin vac group was 8.3% over 30 days from operation, compared with 32% in the OpSite group. Average length of stay for patients with the pressure dressing was 6.1 days, while patients with an OpSite dressing had a length of 14.7 days, more than double, according to lead author Donal Peter O’Leary, MD, surgeon at Cork University Hospital, Ireland.

The difference in length of stay does become insignificant if six OpSite patients who stayed longer than 20 days are discounted, only two of whom were delayed because of wound complications as opposed to placement issues or unassociated infections.

“But a surgical site infection difference of 50% or more using a skin vac instead of a standard dressing, whether you’re talking about clean, clean-contaminated, or contaminated cases with a skin closure, seems to be worthy of notice,” explained Dr. Jones.

[email protected]

LAKE BUENA VISTA, FLA. – Every year brings new studies, updates, and trials, and it can be a challenge to keep up.

Christian Jones, MD, FACS, a general surgeon in the division of acute care surgery at Johns Hopkins University, Baltimore, ranked some of the more notable trauma studies published in the past year and presented his perspective on them at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

Day 2 is the “sweet spot” for cholecystectomy

When it comes to cholecystectomy, acute cholecystitis (AC) patients appear to fare the best when operations are conducted on day 2 after admission, according to a study of patients registered in the Swedish Registry of Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks).

The retrospective study of 15,760 AC patients found that the rate of 30-day mortality of AC patients was significantly higher for patients who underwent a cholecystectomy on day of (odds ratio = .42) 3 days after (OR = .34), and 4 days after admission (OR = 1.0), compared with those who were operated on between 1 day after (OR = .23), and 2 days after (OR = .29) admission.

Lead author My Blohm, MD, of the department of clinical sciences, intervention, and technology at the Karolinska Institutet, Stockholm, and fellow investigators hypothesized that waiting allows patients to be medically optimized for surgery (J Gastrointest Surg. 2017;21[1]: 33-40).

With 90-day mortality rates showing nearly identical results for day 1 and day 2, holding off on surgery may be the best move for the patient, even if it is not the ideal situation for a provider.

“Sure, as we all know by now, delayed cholecystectomy is seldom necessary, later surgery is more difficult, and more likely to be associated with complications at least with an equal conversion to an open procedure, but even more surprising is the higher mortality on the admissions day,” said Dr. Jones.

Antibiotics for abscess drainage patients

For patients requiring abscess drainage, antibiotics may be the best bet to keep infection at bay, according to a study published in the New England Journal of Medicine in June 2017.

The prospective, randomized, placebo-controlled, double-blind, study of 786 simple skin abscess drainage patients found clindamycin and Bactrim (sulfamethoxazole and trimethoprim) outperformed a placebo in an evaluation of symptoms of true ongoing infection in patients even 30 days after the procedure (N Engl J Med. 2017 Jun 29;376[26]:2545-55).

Patients studied had Staphylococcus aureus (527) or methicillin-resistant S. aureus (388).

After 10 days of therapy, cure rate of infection for the clindamycin and Bactrim groups were 83% and 82% respectively, compared with 70% in the placebo group, according to Robert S. Daum, MD, principal investigator at the MRSA Research Center, University of Chicago. After 30 days, cure rate for both antibiotic groups remained superior to that of the placebo group.

While these treatments were successful, concern of drug resistance is notable and should be taken into consideration when deciding on treatment options.

“This does get to our typical concern with increased antibiotic usage, and that’s the concern of the health of the community versus the health of the individual patient,” said Dr. Jones. “Is the increased rate of [antibiotic] resistance important enough to have a lower cure rate of simple abscess drainage? We don’t know the answer to that.”

Loop ileostomies look good for C. diff patients

This minimally invasive procedure has been the subject of some well-received studies with findings that indicate it is a promising choice for patients with a Clostridium difficile–associated disease (CDAD) over total colectomy, Dr. Jones said.

In a study published in the Journal of Trauma and Acute Care Surgery, a study group of patients with CDAD who had loop ileostomy had no statistical difference in almost any recorded characteristic compared with those who underwent a total colectomy, except mortality rate. The retrospective, multicenter study of 98 CDAD patients found the mortality rate of the loop ileostomy group to be 17.2%, compared with 39.7% in the total colectomy group (J Trauma Acute Care Surg. 2017 Jul;83[1]:36-40).

“The outcomes all favored loop ileostomy in a statistically significant fashion,” said Dr. Jones. “Unsurprisingly, estimated blood loss and need for transfusions were all significantly less in the loop ileostomy patients, and the adjusted overall mortality, even if requiring a reoperation, still favored doing the loop ileostomy first.”

The one difference between LI and colectomy patients was a longer time from initial diagnosis to operation among LI patients, with about 12 hours from diagnosis for the colectomy versus 24 hours for LI patients, according to lead author Paula Ferrada, MD, FACS, director of the surgical and trauma intensive care unit at Virginia Commonwealth University, Richmond, and her fellow investigators,

Contrary to previous findings, the study found that LI can be performed on sick patients as well, according to the researchers, and failure of the procedure is not associated with increased mortality.

While these findings are encouraging, “there are things that the individual patient may reveal to you on your examination that tell you they are not a candidate and that you should go to total colectomy,” said Dr. Jones. “Keep in mind that perhaps we can be a bit more aggressive in this less invasive procedure.”
 

The skin vac actually works

A study published in Annals of Surgery found prophylactic negative-pressure dressings are associated with a decreased rate of surgical site infections in laparotomy wounds.

“The biggest surprise to me out of all of these studies is that a new piece of technology actually seems to work,” said Dr. Jones.

The randomized study included 50 laparotomy patients with a stapled wound, half of whom received a skin vac over their incision while the other half had a standard OpSite occlusive dressing (Ann Surg. 2017 Jun;265[6]:1082-6).

Patients in both arms had the same type of wound and had their dressings on for 4 days before being switched.

Rate of surgical site infections for the skin vac group was 8.3% over 30 days from operation, compared with 32% in the OpSite group. Average length of stay for patients with the pressure dressing was 6.1 days, while patients with an OpSite dressing had a length of 14.7 days, more than double, according to lead author Donal Peter O’Leary, MD, surgeon at Cork University Hospital, Ireland.

The difference in length of stay does become insignificant if six OpSite patients who stayed longer than 20 days are discounted, only two of whom were delayed because of wound complications as opposed to placement issues or unassociated infections.

“But a surgical site infection difference of 50% or more using a skin vac instead of a standard dressing, whether you’re talking about clean, clean-contaminated, or contaminated cases with a skin closure, seems to be worthy of notice,” explained Dr. Jones.

[email protected]

A salmon-colored background and prominent serpentine blood vessels are two characteristic features of primary cutaneous B-cell lymphoma (PCBCL) that can be identified dermoscopically and may aid diagnosis, researchers say.

In the January issue of the Journal of the European Academy of Dermatology and Venereology, researchers reported the results of a retrospective observational study using the dermoscopic images of 58 biopsy-confirmed primary cutaneous B-cell lymphoma lesions in 51 patients.

While all the lesions were nonpigmented, 46 (79.3%) of them showed salmon- or yellow- to orange- colored background areas. More than three-quarters of the lesions also featured prominent blood vessels (77.6%), the majority of which were serpentine in nature.

Just over half of the PCBCL lesions (55%) featured both a salmon-colored background and serpentine blood vessels, while only 8.6% of the lesions showed neither feature.

Of the 58 lesions, the authors selected 17 to be evaluated by two dermoscopy experts who were blinded to the diagnosis. In 70.6% of these cases they included cutaneous B-cell lymphoma in the differential diagnosis, while other diagnoses included spider bite (58.8%), basal cell carcinoma (52.9%), amelanotic melanoma (47.1%), and scar/keloid (47.1%). Overall, the two experts did not agree on almost 30% of the suggested differential diagnoses.

“The presentation of cutaneous lymphomas in general and of PCBCLs in particular can be nonspecific, and a biopsy is essential for a definitive diagnosis,” wrote Shamir Geller, MD, of the dermatology service at Memorial Sloan Kettering Cancer Center, New York, and his coauthors.

The 58 PCBCLs analyzed were among 172 biopsy-proven PCBCL lesions in the study, which were newly diagnosed and whose pathology reports included the clinical differential diagnosis in the pathology requisition slip, in patients referred to the cancer center between 1992 and 2016. In only 16.3% of these cases, the clinician suspected cutaneous lymphoma. Skin malignancies were suspected in 54.7% of cases, with the leading diagnosis being basal cell carcinoma in 17.4% of cases. Basal cell carcinoma was considered in nearly one-third of lesions, particularly those on the head and neck.

Nonneoplastic conditions suspected by clinicians included cyst in 21.5% of cases, granulomatous processes in 15.7%, and infectious disease in 4.7%.

The authors commented that a low index of suspicion for skin lymphoma was seen regardless of the subtype or site.

“While dermoscopy offers a bridge between the naked eye examination and the histopathological appearance, cutaneous lymphoma is diagnosed on a cellular level using histopathology, immunohistochemistry and molecular studies,” they wrote. “Therefore, dermoscopy may serve as an ancillary tool in PCBCL; however, it cannot be diagnostic.”

The study was supported in part by the National Institutes of Health/National Cancer Institute Cancer Center. Dr. Geller is a recipient of a grant from the American Physicians and Friends For Medicine in Israel. No conflicts of interest were declared.

SOURCE: Geller S et al. J Eur Acad Dermatol Venereol. 2018 Jan;32(1):53-6.

A salmon-colored background and prominent serpentine blood vessels are two characteristic features of primary cutaneous B-cell lymphoma (PCBCL) that can be identified dermoscopically and may aid diagnosis, researchers say.

In the January issue of the Journal of the European Academy of Dermatology and Venereology, researchers reported the results of a retrospective observational study using the dermoscopic images of 58 biopsy-confirmed primary cutaneous B-cell lymphoma lesions in 51 patients.

While all the lesions were nonpigmented, 46 (79.3%) of them showed salmon- or yellow- to orange- colored background areas. More than three-quarters of the lesions also featured prominent blood vessels (77.6%), the majority of which were serpentine in nature.

Just over half of the PCBCL lesions (55%) featured both a salmon-colored background and serpentine blood vessels, while only 8.6% of the lesions showed neither feature.

Of the 58 lesions, the authors selected 17 to be evaluated by two dermoscopy experts who were blinded to the diagnosis. In 70.6% of these cases they included cutaneous B-cell lymphoma in the differential diagnosis, while other diagnoses included spider bite (58.8%), basal cell carcinoma (52.9%), amelanotic melanoma (47.1%), and scar/keloid (47.1%). Overall, the two experts did not agree on almost 30% of the suggested differential diagnoses.

“The presentation of cutaneous lymphomas in general and of PCBCLs in particular can be nonspecific, and a biopsy is essential for a definitive diagnosis,” wrote Shamir Geller, MD, of the dermatology service at Memorial Sloan Kettering Cancer Center, New York, and his coauthors.

The 58 PCBCLs analyzed were among 172 biopsy-proven PCBCL lesions in the study, which were newly diagnosed and whose pathology reports included the clinical differential diagnosis in the pathology requisition slip, in patients referred to the cancer center between 1992 and 2016. In only 16.3% of these cases, the clinician suspected cutaneous lymphoma. Skin malignancies were suspected in 54.7% of cases, with the leading diagnosis being basal cell carcinoma in 17.4% of cases. Basal cell carcinoma was considered in nearly one-third of lesions, particularly those on the head and neck.

Nonneoplastic conditions suspected by clinicians included cyst in 21.5% of cases, granulomatous processes in 15.7%, and infectious disease in 4.7%.

The authors commented that a low index of suspicion for skin lymphoma was seen regardless of the subtype or site.

“While dermoscopy offers a bridge between the naked eye examination and the histopathological appearance, cutaneous lymphoma is diagnosed on a cellular level using histopathology, immunohistochemistry and molecular studies,” they wrote. “Therefore, dermoscopy may serve as an ancillary tool in PCBCL; however, it cannot be diagnostic.”

The study was supported in part by the National Institutes of Health/National Cancer Institute Cancer Center. Dr. Geller is a recipient of a grant from the American Physicians and Friends For Medicine in Israel. No conflicts of interest were declared.

SOURCE: Geller S et al. J Eur Acad Dermatol Venereol. 2018 Jan;32(1):53-6.

A salmon-colored background and prominent serpentine blood vessels are two characteristic features of primary cutaneous B-cell lymphoma (PCBCL) that can be identified dermoscopically and may aid diagnosis, researchers say.

In the January issue of the Journal of the European Academy of Dermatology and Venereology, researchers reported the results of a retrospective observational study using the dermoscopic images of 58 biopsy-confirmed primary cutaneous B-cell lymphoma lesions in 51 patients.

While all the lesions were nonpigmented, 46 (79.3%) of them showed salmon- or yellow- to orange- colored background areas. More than three-quarters of the lesions also featured prominent blood vessels (77.6%), the majority of which were serpentine in nature.

Just over half of the PCBCL lesions (55%) featured both a salmon-colored background and serpentine blood vessels, while only 8.6% of the lesions showed neither feature.

Of the 58 lesions, the authors selected 17 to be evaluated by two dermoscopy experts who were blinded to the diagnosis. In 70.6% of these cases they included cutaneous B-cell lymphoma in the differential diagnosis, while other diagnoses included spider bite (58.8%), basal cell carcinoma (52.9%), amelanotic melanoma (47.1%), and scar/keloid (47.1%). Overall, the two experts did not agree on almost 30% of the suggested differential diagnoses.

“The presentation of cutaneous lymphomas in general and of PCBCLs in particular can be nonspecific, and a biopsy is essential for a definitive diagnosis,” wrote Shamir Geller, MD, of the dermatology service at Memorial Sloan Kettering Cancer Center, New York, and his coauthors.

The 58 PCBCLs analyzed were among 172 biopsy-proven PCBCL lesions in the study, which were newly diagnosed and whose pathology reports included the clinical differential diagnosis in the pathology requisition slip, in patients referred to the cancer center between 1992 and 2016. In only 16.3% of these cases, the clinician suspected cutaneous lymphoma. Skin malignancies were suspected in 54.7% of cases, with the leading diagnosis being basal cell carcinoma in 17.4% of cases. Basal cell carcinoma was considered in nearly one-third of lesions, particularly those on the head and neck.

Nonneoplastic conditions suspected by clinicians included cyst in 21.5% of cases, granulomatous processes in 15.7%, and infectious disease in 4.7%.

The authors commented that a low index of suspicion for skin lymphoma was seen regardless of the subtype or site.

“While dermoscopy offers a bridge between the naked eye examination and the histopathological appearance, cutaneous lymphoma is diagnosed on a cellular level using histopathology, immunohistochemistry and molecular studies,” they wrote. “Therefore, dermoscopy may serve as an ancillary tool in PCBCL; however, it cannot be diagnostic.”

The study was supported in part by the National Institutes of Health/National Cancer Institute Cancer Center. Dr. Geller is a recipient of a grant from the American Physicians and Friends For Medicine in Israel. No conflicts of interest were declared.

SOURCE: Geller S et al. J Eur Acad Dermatol Venereol. 2018 Jan;32(1):53-6.

CHICAGO – The use of therapeutic-dose anticoagulation in hospitalized patients with calf vein thrombosis significantly reduces the risk of venous thromboembolic complications, compared with lower-dose prophylactic anticoagulation or surveillance alone, Heron E. Rodriguez, MD, said at a symposium on vascular surgery sponsored by Northwestern University.

Moreover, placement of an inferior vena cava filter in patients with calf vein thrombosis when anticoagulation is contraindicated accomplishes nothing beneficial and had a 10% complication rate in a large retrospective single-center study, added Dr. Rodriguez of Northwestern University, Chicago.

Bruce Jancin/Frontline Medical News

[email protected]

CHICAGO – The use of therapeutic-dose anticoagulation in hospitalized patients with calf vein thrombosis significantly reduces the risk of venous thromboembolic complications, compared with lower-dose prophylactic anticoagulation or surveillance alone, Heron E. Rodriguez, MD, said at a symposium on vascular surgery sponsored by Northwestern University.

Moreover, placement of an inferior vena cava filter in patients with calf vein thrombosis when anticoagulation is contraindicated accomplishes nothing beneficial and had a 10% complication rate in a large retrospective single-center study, added Dr. Rodriguez of Northwestern University, Chicago.

Bruce Jancin/Frontline Medical News

[email protected]

CHICAGO – The use of therapeutic-dose anticoagulation in hospitalized patients with calf vein thrombosis significantly reduces the risk of venous thromboembolic complications, compared with lower-dose prophylactic anticoagulation or surveillance alone, Heron E. Rodriguez, MD, said at a symposium on vascular surgery sponsored by Northwestern University.

Moreover, placement of an inferior vena cava filter in patients with calf vein thrombosis when anticoagulation is contraindicated accomplishes nothing beneficial and had a 10% complication rate in a large retrospective single-center study, added Dr. Rodriguez of Northwestern University, Chicago.

Bruce Jancin/Frontline Medical News

[email protected]