Low-sodium DASH benefits increase with higher blood pressures

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– The low-sodium DASH diet lowered systolic BP a mean of 20.8 mm Hg among patients with a baseline systolic pressure of 150-159 mm Hg, and did so in just 4 weeks, according to a new analysis of the DASH-Sodium trial.

The original 2001 study found that combining low sodium and the DASH [Dietary Approaches to Stop Hypertension] diet lowered blood pressure more than either alone, but results were not broken out by hypertension severity (N Engl J Med. 2001 Jan 4;344[1]:3-10).

Dr. Stephen Juraschek
That was the goal of the new analysis, which was presented by Stephen Juraschek, MD, PHD, at the American Heart Association scientific sessions.

It found that there were “progressively greater reductions at higher levels of baseline systolic BP (SBP). Among participants with baseline SBP at or above 150 mm Hg, “mean SBP reduction was striking,” said Dr. Juraschek, of Harvard Medical School/Beth Israel Deaconess Medical Center, Boston.

The original trial randomized 208 subjects to the DASH diet and 204 to a control diet similar to what most Americans eat. While on their diets, the subjects cycled through three sodium levels for 4 weeks each: 1.5 g/d, 2.4 g/d, and 3.3 g/d. Although deemed high sodium in the study, 3.3 g/d is typical of the American diet.

The new study analyzed outcomes according to four baseline SBP categories: 120-129, 130-139, 140-149, and 150-159 mm Hg.

Among subjects on the control diet, reducing sodium from high to low intake reduced SBP 3.20, 8.56, 8.99, and 7.04 mm Hg across the four baseline SBP categories (P = .004). Among patients consuming high sodium, the DASH diet, compared with the control diet, reduced SBP 4.5, 4.3, 4.7, and 10.6 mm Hg, but the trend was not statistically significant.

The low-sodium DASH diet, versus the high-sodium control diet, reduced SBP 5.3, 7.5, 9.7, and 20.8 mm Hg in subjects with baseline SBP at or above 150 mmHg (P < .001).

“The DASH diet with low sodium, compared with the control diet with high sodium, lowered SBP by nearly 10 mm Hg among those with a baseline SBP of 140-149 mm Hg and [greater than] 20 mm Hg among those with a baseline systolic BP [at or above] 150 mm Hg. SBP levels between 140 and 159 mm Hg represent the majority of patients with hypertension. Thus, our findings suggest that most adults with uncontrolled BP can experience substantial reductions in SBP from dietary changes alone,” the investigator said.

“To place our results in context, compared to placebo, angiotensin-converting enzyme inhibitors reduce SBP by 12 mm Hg, beta-blockers reduce SBP by 13 mm Hg, and calcium-channel blockers reduce SBP by 16 mm Hg,” he said.

“For many patients, it’s hard to take that step to be on a chronic medication. A lot of them want to talk about diet, but” find it hard to believe that something as simple as changing what you eat could beat drugs. “It’s important for both patients and physicians to realize that if you take this seriously, you can have significant reductions in your blood pressure. We should take it seriously as the first step. That’s the key take away,” Dr. Juraschek said in an interview.

None of the participants were on blood pressure medications; 57% were women, and 57% were black. The mean age was 48 years, and mean baseline BP was 135/86 mm Hg. The DASH diet includes whole grains, poultry, fish, and nuts, with reductions in red meat, sweets, and sugary drinks.

The results were published, online simultaneously with Dr. Juraschek’s presentation (J Am Coll Cardiol. 2017 Nov 12;doi: 10.1016/j.jacc.2017.10.011).

The original study was funded by the National Institutes of Health. Dr. Juraschek had no relevant disclosures.
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– The low-sodium DASH diet lowered systolic BP a mean of 20.8 mm Hg among patients with a baseline systolic pressure of 150-159 mm Hg, and did so in just 4 weeks, according to a new analysis of the DASH-Sodium trial.

The original 2001 study found that combining low sodium and the DASH [Dietary Approaches to Stop Hypertension] diet lowered blood pressure more than either alone, but results were not broken out by hypertension severity (N Engl J Med. 2001 Jan 4;344[1]:3-10).

Dr. Stephen Juraschek
That was the goal of the new analysis, which was presented by Stephen Juraschek, MD, PHD, at the American Heart Association scientific sessions.

It found that there were “progressively greater reductions at higher levels of baseline systolic BP (SBP). Among participants with baseline SBP at or above 150 mm Hg, “mean SBP reduction was striking,” said Dr. Juraschek, of Harvard Medical School/Beth Israel Deaconess Medical Center, Boston.

The original trial randomized 208 subjects to the DASH diet and 204 to a control diet similar to what most Americans eat. While on their diets, the subjects cycled through three sodium levels for 4 weeks each: 1.5 g/d, 2.4 g/d, and 3.3 g/d. Although deemed high sodium in the study, 3.3 g/d is typical of the American diet.

The new study analyzed outcomes according to four baseline SBP categories: 120-129, 130-139, 140-149, and 150-159 mm Hg.

Among subjects on the control diet, reducing sodium from high to low intake reduced SBP 3.20, 8.56, 8.99, and 7.04 mm Hg across the four baseline SBP categories (P = .004). Among patients consuming high sodium, the DASH diet, compared with the control diet, reduced SBP 4.5, 4.3, 4.7, and 10.6 mm Hg, but the trend was not statistically significant.

The low-sodium DASH diet, versus the high-sodium control diet, reduced SBP 5.3, 7.5, 9.7, and 20.8 mm Hg in subjects with baseline SBP at or above 150 mmHg (P < .001).

“The DASH diet with low sodium, compared with the control diet with high sodium, lowered SBP by nearly 10 mm Hg among those with a baseline SBP of 140-149 mm Hg and [greater than] 20 mm Hg among those with a baseline systolic BP [at or above] 150 mm Hg. SBP levels between 140 and 159 mm Hg represent the majority of patients with hypertension. Thus, our findings suggest that most adults with uncontrolled BP can experience substantial reductions in SBP from dietary changes alone,” the investigator said.

“To place our results in context, compared to placebo, angiotensin-converting enzyme inhibitors reduce SBP by 12 mm Hg, beta-blockers reduce SBP by 13 mm Hg, and calcium-channel blockers reduce SBP by 16 mm Hg,” he said.

“For many patients, it’s hard to take that step to be on a chronic medication. A lot of them want to talk about diet, but” find it hard to believe that something as simple as changing what you eat could beat drugs. “It’s important for both patients and physicians to realize that if you take this seriously, you can have significant reductions in your blood pressure. We should take it seriously as the first step. That’s the key take away,” Dr. Juraschek said in an interview.

None of the participants were on blood pressure medications; 57% were women, and 57% were black. The mean age was 48 years, and mean baseline BP was 135/86 mm Hg. The DASH diet includes whole grains, poultry, fish, and nuts, with reductions in red meat, sweets, and sugary drinks.

The results were published, online simultaneously with Dr. Juraschek’s presentation (J Am Coll Cardiol. 2017 Nov 12;doi: 10.1016/j.jacc.2017.10.011).

The original study was funded by the National Institutes of Health. Dr. Juraschek had no relevant disclosures.

 

– The low-sodium DASH diet lowered systolic BP a mean of 20.8 mm Hg among patients with a baseline systolic pressure of 150-159 mm Hg, and did so in just 4 weeks, according to a new analysis of the DASH-Sodium trial.

The original 2001 study found that combining low sodium and the DASH [Dietary Approaches to Stop Hypertension] diet lowered blood pressure more than either alone, but results were not broken out by hypertension severity (N Engl J Med. 2001 Jan 4;344[1]:3-10).

Dr. Stephen Juraschek
That was the goal of the new analysis, which was presented by Stephen Juraschek, MD, PHD, at the American Heart Association scientific sessions.

It found that there were “progressively greater reductions at higher levels of baseline systolic BP (SBP). Among participants with baseline SBP at or above 150 mm Hg, “mean SBP reduction was striking,” said Dr. Juraschek, of Harvard Medical School/Beth Israel Deaconess Medical Center, Boston.

The original trial randomized 208 subjects to the DASH diet and 204 to a control diet similar to what most Americans eat. While on their diets, the subjects cycled through three sodium levels for 4 weeks each: 1.5 g/d, 2.4 g/d, and 3.3 g/d. Although deemed high sodium in the study, 3.3 g/d is typical of the American diet.

The new study analyzed outcomes according to four baseline SBP categories: 120-129, 130-139, 140-149, and 150-159 mm Hg.

Among subjects on the control diet, reducing sodium from high to low intake reduced SBP 3.20, 8.56, 8.99, and 7.04 mm Hg across the four baseline SBP categories (P = .004). Among patients consuming high sodium, the DASH diet, compared with the control diet, reduced SBP 4.5, 4.3, 4.7, and 10.6 mm Hg, but the trend was not statistically significant.

The low-sodium DASH diet, versus the high-sodium control diet, reduced SBP 5.3, 7.5, 9.7, and 20.8 mm Hg in subjects with baseline SBP at or above 150 mmHg (P < .001).

“The DASH diet with low sodium, compared with the control diet with high sodium, lowered SBP by nearly 10 mm Hg among those with a baseline SBP of 140-149 mm Hg and [greater than] 20 mm Hg among those with a baseline systolic BP [at or above] 150 mm Hg. SBP levels between 140 and 159 mm Hg represent the majority of patients with hypertension. Thus, our findings suggest that most adults with uncontrolled BP can experience substantial reductions in SBP from dietary changes alone,” the investigator said.

“To place our results in context, compared to placebo, angiotensin-converting enzyme inhibitors reduce SBP by 12 mm Hg, beta-blockers reduce SBP by 13 mm Hg, and calcium-channel blockers reduce SBP by 16 mm Hg,” he said.

“For many patients, it’s hard to take that step to be on a chronic medication. A lot of them want to talk about diet, but” find it hard to believe that something as simple as changing what you eat could beat drugs. “It’s important for both patients and physicians to realize that if you take this seriously, you can have significant reductions in your blood pressure. We should take it seriously as the first step. That’s the key take away,” Dr. Juraschek said in an interview.

None of the participants were on blood pressure medications; 57% were women, and 57% were black. The mean age was 48 years, and mean baseline BP was 135/86 mm Hg. The DASH diet includes whole grains, poultry, fish, and nuts, with reductions in red meat, sweets, and sugary drinks.

The results were published, online simultaneously with Dr. Juraschek’s presentation (J Am Coll Cardiol. 2017 Nov 12;doi: 10.1016/j.jacc.2017.10.011).

The original study was funded by the National Institutes of Health. Dr. Juraschek had no relevant disclosures.
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Key clinical point: The higher the blood pressure, the more there is to gain from a low-sodium DASH diet.

Major finding: The low-sodium DASH diet lowered systolic BP a mean of 20.8 mm Hg among patients with a baseline systolic pressure of 150-159 mm Hg, and did so in just 4 weeks.

Data source: New analysis of the landmark DASH-Sodium trial.

Disclosures: The original study was funded by the National Institutes of Health. The lead investigator in the new analysis didn’t have any relevant disclosures.

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Virtual House Calls Are Feasible for Patients With Parkinson’s Disease

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Participants prefer virtual visits with a remote specialist to their standard in-person clinician.

Providing remote neurologic care directly into the homes of patients with Parkinson’s disease is feasible and is neither more nor less efficacious than usual in-person care, according to research published in the September 12 issue of Neurology. Virtual house calls are also efficient, eliminating approximately 35,000 miles of travel, and reducing the need for parking lots, waiting rooms, and clinic space.

Christopher A. Beck, PhD
“The [virtual] visits provide most patients the care that they prefer, the convenience that they need, and the comfort that they value,” said lead author Christopher A. Beck, PhD, Associate Professor of Biostatistics and Orthopedics at the University of Rochester in New York, and colleagues.

Virtual house calls are becoming increasingly common for episodic conditions, but limited evidence supports their use for chronic conditions, according to the researchers. Approximately 40% of patients with Parkinson’s disease never receive care from a neurologist. These patients are more likely to have increased morbidity, to lose independence, and to die prematurely, they said.

Standard Care Versus Virtual House Calls

To determine whether providing virtual house calls is feasible, valuable, and beneficial, Dr. Beck and colleagues conducted a one-year randomized controlled study. Eligible participants had a clinical diagnosis of Parkinson’s disease; had a private, Internet-enabled device; and lived in a state where a site investigator was licensed to practice. Patients currently hospitalized, who had a condition that would preclude study participation in the judgment of the site investigator, or who were currently enrolled in another telemedicine study were excluded.

Investigators compared usual care to usual care supplemented with four virtual visits via video conferencing from a remote specialist into patients’ homes. Primary outcome measures were feasibility, measured by the proportion of participants who completed at least one virtual visit and the proportion of virtual visits completed on time, and efficacy, measured by change in the Parkinson’s Disease Questionnaire-39, a quality of life scale. Secondary outcomes included quality of care, caregiver burden, and time and travel savings.

Most Participants Were Satisfied With Virtual Visits

A total of 927 patients indicated interest in the study. Of these, 732 were excluded because they did not meet eligibility requirements, did not consent, or withdrew prior to randomization. A total of 210 patients were enrolled, and 195 were randomized. In all, 73% of participants had recently visited a specialist, 73% were college-educated, and 96% were white. The mean age of participants was 66. Ninety-eight percent of participants randomized to the intervention arm completed at least one virtual visit; 91% of 388 virtual visits were completed.

Quality of life did not improve for patients who received virtual house calls, nor did quality of care or caregiver burden. However, each virtual house call saved patients a median of 88 minutes per visit and 38 miles per visit. Ninety-seven percent of patients and 86% of physicians were satisfied or very satisfied with virtual visits.

One limitation of this study was that the majority of participants were white, well educated, and more familiar with the Internet than the general population. “Dedicated outreach to underserved populations, including those with advanced disease and from underserved demographic groups, especially women, rural residents, minorities, the homebound, or those in assisted living facilities, will help determine if the results are more generalizable and whether the benefits are potentially greater for those with historically less access to care,” said Dr. Beck and colleagues.

“Virtual house calls generated great interest and provided substantial convenience,” the researchers said. “Future efforts must address the digital divide and policy barriers to ensure that this new care model can address inequities in access to care.”

—Erica Tricarico

Suggested Reading

Beck CA, Beran DB, Biglan KM, et al. National randomized controlled trial of virtual house calls for Parkinson disease. Neurology. 2017;89(11):1152-1161.

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Participants prefer virtual visits with a remote specialist to their standard in-person clinician.
Participants prefer virtual visits with a remote specialist to their standard in-person clinician.

Providing remote neurologic care directly into the homes of patients with Parkinson’s disease is feasible and is neither more nor less efficacious than usual in-person care, according to research published in the September 12 issue of Neurology. Virtual house calls are also efficient, eliminating approximately 35,000 miles of travel, and reducing the need for parking lots, waiting rooms, and clinic space.

Christopher A. Beck, PhD
“The [virtual] visits provide most patients the care that they prefer, the convenience that they need, and the comfort that they value,” said lead author Christopher A. Beck, PhD, Associate Professor of Biostatistics and Orthopedics at the University of Rochester in New York, and colleagues.

Virtual house calls are becoming increasingly common for episodic conditions, but limited evidence supports their use for chronic conditions, according to the researchers. Approximately 40% of patients with Parkinson’s disease never receive care from a neurologist. These patients are more likely to have increased morbidity, to lose independence, and to die prematurely, they said.

Standard Care Versus Virtual House Calls

To determine whether providing virtual house calls is feasible, valuable, and beneficial, Dr. Beck and colleagues conducted a one-year randomized controlled study. Eligible participants had a clinical diagnosis of Parkinson’s disease; had a private, Internet-enabled device; and lived in a state where a site investigator was licensed to practice. Patients currently hospitalized, who had a condition that would preclude study participation in the judgment of the site investigator, or who were currently enrolled in another telemedicine study were excluded.

Investigators compared usual care to usual care supplemented with four virtual visits via video conferencing from a remote specialist into patients’ homes. Primary outcome measures were feasibility, measured by the proportion of participants who completed at least one virtual visit and the proportion of virtual visits completed on time, and efficacy, measured by change in the Parkinson’s Disease Questionnaire-39, a quality of life scale. Secondary outcomes included quality of care, caregiver burden, and time and travel savings.

Most Participants Were Satisfied With Virtual Visits

A total of 927 patients indicated interest in the study. Of these, 732 were excluded because they did not meet eligibility requirements, did not consent, or withdrew prior to randomization. A total of 210 patients were enrolled, and 195 were randomized. In all, 73% of participants had recently visited a specialist, 73% were college-educated, and 96% were white. The mean age of participants was 66. Ninety-eight percent of participants randomized to the intervention arm completed at least one virtual visit; 91% of 388 virtual visits were completed.

Quality of life did not improve for patients who received virtual house calls, nor did quality of care or caregiver burden. However, each virtual house call saved patients a median of 88 minutes per visit and 38 miles per visit. Ninety-seven percent of patients and 86% of physicians were satisfied or very satisfied with virtual visits.

One limitation of this study was that the majority of participants were white, well educated, and more familiar with the Internet than the general population. “Dedicated outreach to underserved populations, including those with advanced disease and from underserved demographic groups, especially women, rural residents, minorities, the homebound, or those in assisted living facilities, will help determine if the results are more generalizable and whether the benefits are potentially greater for those with historically less access to care,” said Dr. Beck and colleagues.

“Virtual house calls generated great interest and provided substantial convenience,” the researchers said. “Future efforts must address the digital divide and policy barriers to ensure that this new care model can address inequities in access to care.”

—Erica Tricarico

Suggested Reading

Beck CA, Beran DB, Biglan KM, et al. National randomized controlled trial of virtual house calls for Parkinson disease. Neurology. 2017;89(11):1152-1161.

Providing remote neurologic care directly into the homes of patients with Parkinson’s disease is feasible and is neither more nor less efficacious than usual in-person care, according to research published in the September 12 issue of Neurology. Virtual house calls are also efficient, eliminating approximately 35,000 miles of travel, and reducing the need for parking lots, waiting rooms, and clinic space.

Christopher A. Beck, PhD
“The [virtual] visits provide most patients the care that they prefer, the convenience that they need, and the comfort that they value,” said lead author Christopher A. Beck, PhD, Associate Professor of Biostatistics and Orthopedics at the University of Rochester in New York, and colleagues.

Virtual house calls are becoming increasingly common for episodic conditions, but limited evidence supports their use for chronic conditions, according to the researchers. Approximately 40% of patients with Parkinson’s disease never receive care from a neurologist. These patients are more likely to have increased morbidity, to lose independence, and to die prematurely, they said.

Standard Care Versus Virtual House Calls

To determine whether providing virtual house calls is feasible, valuable, and beneficial, Dr. Beck and colleagues conducted a one-year randomized controlled study. Eligible participants had a clinical diagnosis of Parkinson’s disease; had a private, Internet-enabled device; and lived in a state where a site investigator was licensed to practice. Patients currently hospitalized, who had a condition that would preclude study participation in the judgment of the site investigator, or who were currently enrolled in another telemedicine study were excluded.

Investigators compared usual care to usual care supplemented with four virtual visits via video conferencing from a remote specialist into patients’ homes. Primary outcome measures were feasibility, measured by the proportion of participants who completed at least one virtual visit and the proportion of virtual visits completed on time, and efficacy, measured by change in the Parkinson’s Disease Questionnaire-39, a quality of life scale. Secondary outcomes included quality of care, caregiver burden, and time and travel savings.

Most Participants Were Satisfied With Virtual Visits

A total of 927 patients indicated interest in the study. Of these, 732 were excluded because they did not meet eligibility requirements, did not consent, or withdrew prior to randomization. A total of 210 patients were enrolled, and 195 were randomized. In all, 73% of participants had recently visited a specialist, 73% were college-educated, and 96% were white. The mean age of participants was 66. Ninety-eight percent of participants randomized to the intervention arm completed at least one virtual visit; 91% of 388 virtual visits were completed.

Quality of life did not improve for patients who received virtual house calls, nor did quality of care or caregiver burden. However, each virtual house call saved patients a median of 88 minutes per visit and 38 miles per visit. Ninety-seven percent of patients and 86% of physicians were satisfied or very satisfied with virtual visits.

One limitation of this study was that the majority of participants were white, well educated, and more familiar with the Internet than the general population. “Dedicated outreach to underserved populations, including those with advanced disease and from underserved demographic groups, especially women, rural residents, minorities, the homebound, or those in assisted living facilities, will help determine if the results are more generalizable and whether the benefits are potentially greater for those with historically less access to care,” said Dr. Beck and colleagues.

“Virtual house calls generated great interest and provided substantial convenience,” the researchers said. “Future efforts must address the digital divide and policy barriers to ensure that this new care model can address inequities in access to care.”

—Erica Tricarico

Suggested Reading

Beck CA, Beran DB, Biglan KM, et al. National randomized controlled trial of virtual house calls for Parkinson disease. Neurology. 2017;89(11):1152-1161.

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FDA approves Vimpat for POS treatment in children with epilepsy

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The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.

The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.

The most common adverse events associated with lacosamide are dizziness, headache, nausea, and diplopia. In addition, antiepileptic drugs such as lacosamide are associated with an increased risk of suicidal behavior or ideation, and patients should be monitored for new or worsening depression.

“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD, professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.

Find the full press release on the UCB website.

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The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.

The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.

The most common adverse events associated with lacosamide are dizziness, headache, nausea, and diplopia. In addition, antiepileptic drugs such as lacosamide are associated with an increased risk of suicidal behavior or ideation, and patients should be monitored for new or worsening depression.

“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD, professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.

Find the full press release on the UCB website.

 

The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.

The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.

The most common adverse events associated with lacosamide are dizziness, headache, nausea, and diplopia. In addition, antiepileptic drugs such as lacosamide are associated with an increased risk of suicidal behavior or ideation, and patients should be monitored for new or worsening depression.

“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD, professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.

Find the full press release on the UCB website.

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ARDS incidence is declining. Is it a preventable syndrome?

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– The incidence of acute respiratory distress syndrome (ARDS) is on the decline, according to a retrospective, population-based cohort study conducted at the Mayo Clinic in Rochester, Minn.

“This is very promising data in combating this syndrome,” reported Augustin Joseph of the Mayo Clinic, and “it suggests that ARDS may in part be a completely preventable disease.”

Debra L. Beck/Frontline Medical News
Dr. Augustin Joseph
This study was inspired by a previous effort by Guangxi Li et al. who conducted a population-based cohort study on trends in ARDS using data from the Olmsted County (Minn.) Epidemiology Project from 2001 to 2008. (Am J Respir Crit Care Med. 2011;183:59-66). At that time, a steady and significant decline in ARDS incidence was noted, attributable to a reduced incidence of hospital-acquired ARDS. “We attributed this to improvements in hospital practices and management of ARDS and all the research that’s been done over the past 2 decades,” Mr. Joseph said at the CHEST annual meeting.

To see if ARDS incidence has continued to decline, Mr. Joseph’s group studied all patients admitted during 2009-2014 to the Mayo Clinic’s ICU, the only facility in the county that cares for ARDS patients. From 82,388 ICU admissions, they identified 505 patients with ARDS according to the Berlin definition of ARDS developed in 2012.

The number of annual cases dropped from 108 in 2009 to 59 in 2014, and the incidence steadily declined from 74.5 cases per 100,000 in 2009 to 39.3 per 100,000 in 2014.

Median age was 67 years in 2009 and 62 years in 2014. Hospital mortality ranged from 15% to 26% during the study period, while hospital length of stay ranged from 8 to 15 days, with no clear decline in either.

“For hospital and ICU mortality and hospital and ICU length of stay, we did not see much difference [from 2009 to 2014], so the overall picture between the Guangxi Li study and mine was that we did not see much of a difference in the patients who had ARDS, but [in terms of] preventing ARDS, the incidence has continued to decline,” Mr. Joseph reported.

While the earlier study used the American-European Consensus Conference (AECC) definition of ARDS, Mr. Joseph and his colleagues diagnosed ARDS according to the Berlin definition. One of the major changes seen in the new Berlin rules is that acute lung injury no longer exists and patients with a P/F ratio (PaO2/FiO2 ratio, or the ratio of arterial oxygen partial pressure to fractional inspired oxygen) between 200 and 300 are now considered to have “mild ARDS,” Mr. Joseph explained. With the AECC definition, a P/F ratio in this range was classified as acute lung injury and only one less than 200 was considered ARDS.

The researchers are now trying to parse out how changing ARDS diagnosis and management at their institution might be contributing to declining incidence, said Mr. Joseph.
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– The incidence of acute respiratory distress syndrome (ARDS) is on the decline, according to a retrospective, population-based cohort study conducted at the Mayo Clinic in Rochester, Minn.

“This is very promising data in combating this syndrome,” reported Augustin Joseph of the Mayo Clinic, and “it suggests that ARDS may in part be a completely preventable disease.”

Debra L. Beck/Frontline Medical News
Dr. Augustin Joseph
This study was inspired by a previous effort by Guangxi Li et al. who conducted a population-based cohort study on trends in ARDS using data from the Olmsted County (Minn.) Epidemiology Project from 2001 to 2008. (Am J Respir Crit Care Med. 2011;183:59-66). At that time, a steady and significant decline in ARDS incidence was noted, attributable to a reduced incidence of hospital-acquired ARDS. “We attributed this to improvements in hospital practices and management of ARDS and all the research that’s been done over the past 2 decades,” Mr. Joseph said at the CHEST annual meeting.

To see if ARDS incidence has continued to decline, Mr. Joseph’s group studied all patients admitted during 2009-2014 to the Mayo Clinic’s ICU, the only facility in the county that cares for ARDS patients. From 82,388 ICU admissions, they identified 505 patients with ARDS according to the Berlin definition of ARDS developed in 2012.

The number of annual cases dropped from 108 in 2009 to 59 in 2014, and the incidence steadily declined from 74.5 cases per 100,000 in 2009 to 39.3 per 100,000 in 2014.

Median age was 67 years in 2009 and 62 years in 2014. Hospital mortality ranged from 15% to 26% during the study period, while hospital length of stay ranged from 8 to 15 days, with no clear decline in either.

“For hospital and ICU mortality and hospital and ICU length of stay, we did not see much difference [from 2009 to 2014], so the overall picture between the Guangxi Li study and mine was that we did not see much of a difference in the patients who had ARDS, but [in terms of] preventing ARDS, the incidence has continued to decline,” Mr. Joseph reported.

While the earlier study used the American-European Consensus Conference (AECC) definition of ARDS, Mr. Joseph and his colleagues diagnosed ARDS according to the Berlin definition. One of the major changes seen in the new Berlin rules is that acute lung injury no longer exists and patients with a P/F ratio (PaO2/FiO2 ratio, or the ratio of arterial oxygen partial pressure to fractional inspired oxygen) between 200 and 300 are now considered to have “mild ARDS,” Mr. Joseph explained. With the AECC definition, a P/F ratio in this range was classified as acute lung injury and only one less than 200 was considered ARDS.

The researchers are now trying to parse out how changing ARDS diagnosis and management at their institution might be contributing to declining incidence, said Mr. Joseph.

 

– The incidence of acute respiratory distress syndrome (ARDS) is on the decline, according to a retrospective, population-based cohort study conducted at the Mayo Clinic in Rochester, Minn.

“This is very promising data in combating this syndrome,” reported Augustin Joseph of the Mayo Clinic, and “it suggests that ARDS may in part be a completely preventable disease.”

Debra L. Beck/Frontline Medical News
Dr. Augustin Joseph
This study was inspired by a previous effort by Guangxi Li et al. who conducted a population-based cohort study on trends in ARDS using data from the Olmsted County (Minn.) Epidemiology Project from 2001 to 2008. (Am J Respir Crit Care Med. 2011;183:59-66). At that time, a steady and significant decline in ARDS incidence was noted, attributable to a reduced incidence of hospital-acquired ARDS. “We attributed this to improvements in hospital practices and management of ARDS and all the research that’s been done over the past 2 decades,” Mr. Joseph said at the CHEST annual meeting.

To see if ARDS incidence has continued to decline, Mr. Joseph’s group studied all patients admitted during 2009-2014 to the Mayo Clinic’s ICU, the only facility in the county that cares for ARDS patients. From 82,388 ICU admissions, they identified 505 patients with ARDS according to the Berlin definition of ARDS developed in 2012.

The number of annual cases dropped from 108 in 2009 to 59 in 2014, and the incidence steadily declined from 74.5 cases per 100,000 in 2009 to 39.3 per 100,000 in 2014.

Median age was 67 years in 2009 and 62 years in 2014. Hospital mortality ranged from 15% to 26% during the study period, while hospital length of stay ranged from 8 to 15 days, with no clear decline in either.

“For hospital and ICU mortality and hospital and ICU length of stay, we did not see much difference [from 2009 to 2014], so the overall picture between the Guangxi Li study and mine was that we did not see much of a difference in the patients who had ARDS, but [in terms of] preventing ARDS, the incidence has continued to decline,” Mr. Joseph reported.

While the earlier study used the American-European Consensus Conference (AECC) definition of ARDS, Mr. Joseph and his colleagues diagnosed ARDS according to the Berlin definition. One of the major changes seen in the new Berlin rules is that acute lung injury no longer exists and patients with a P/F ratio (PaO2/FiO2 ratio, or the ratio of arterial oxygen partial pressure to fractional inspired oxygen) between 200 and 300 are now considered to have “mild ARDS,” Mr. Joseph explained. With the AECC definition, a P/F ratio in this range was classified as acute lung injury and only one less than 200 was considered ARDS.

The researchers are now trying to parse out how changing ARDS diagnosis and management at their institution might be contributing to declining incidence, said Mr. Joseph.
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Key clinical point: The incidence of acute respiratory distress syndrome is declining, an indication that it may be preventable, according to researchers.

Major finding: The number of annual cases dropped from 108 in 2009 to 59 in 2014, and the incidence steadily declined from 74.5 cases per 100,000 in 2009 to 39.3 per 100,000 in 2014.

Data source: Retrospective, population-based cohort study of all (505) patients admitted to the ICU for ARDS at a single center.

Disclosures: The authors reported having no relevant disclosures.

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MACRA Monday: Documenting current medications

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If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:
 

Measure #130: Documentation of Current Medications in the Medical Record

This measure is aimed at capturing the percentage of patients aged 18 years and older who had their current medications documented in the medical record, including nonprescription drugs, vitamins, and supplements.

What you need to do: Review and update the patient’s list of current medications, being sure to document all known prescriptions, over-the-counter medications, herbals, and vitamin/mineral/dietary supplements. This list must include the name, dosages, frequency, and route of administration for each drug.

Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 92002, 92004, 92012, 92014, 92507, 92508, 92526, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92547, 92548, 92550, 92557, 92567, 92568, 92570, 92585, 92588, 92626, 96116, 96150, 96151, 96152, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97532, 97802, 97803, 97804, 98960, 98961, 98962, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99221, 99222, 99223, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99495, 99496, G0101, G0108, G0270, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8427 indicates that the patient’s medical record was updated with the current medications. Use exception code G8430 if you documented in the medical record that the patient is not eligible for a current list of medications being obtained and reviewed.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

  • Those who enrolled in Medicare for the first time during a performance period.
  • Those who have Medicare Part B allowed charges of $30,000 or less.
  • Those who have 100 or fewer Medicare Part B patients.
  • Those who are significantly participating in an Advanced Alternative Payment Model (APM).

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:
 

Measure #130: Documentation of Current Medications in the Medical Record

This measure is aimed at capturing the percentage of patients aged 18 years and older who had their current medications documented in the medical record, including nonprescription drugs, vitamins, and supplements.

What you need to do: Review and update the patient’s list of current medications, being sure to document all known prescriptions, over-the-counter medications, herbals, and vitamin/mineral/dietary supplements. This list must include the name, dosages, frequency, and route of administration for each drug.

Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 92002, 92004, 92012, 92014, 92507, 92508, 92526, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92547, 92548, 92550, 92557, 92567, 92568, 92570, 92585, 92588, 92626, 96116, 96150, 96151, 96152, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97532, 97802, 97803, 97804, 98960, 98961, 98962, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99221, 99222, 99223, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99495, 99496, G0101, G0108, G0270, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8427 indicates that the patient’s medical record was updated with the current medications. Use exception code G8430 if you documented in the medical record that the patient is not eligible for a current list of medications being obtained and reviewed.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

  • Those who enrolled in Medicare for the first time during a performance period.
  • Those who have Medicare Part B allowed charges of $30,000 or less.
  • Those who have 100 or fewer Medicare Part B patients.
  • Those who are significantly participating in an Advanced Alternative Payment Model (APM).

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:
 

Measure #130: Documentation of Current Medications in the Medical Record

This measure is aimed at capturing the percentage of patients aged 18 years and older who had their current medications documented in the medical record, including nonprescription drugs, vitamins, and supplements.

What you need to do: Review and update the patient’s list of current medications, being sure to document all known prescriptions, over-the-counter medications, herbals, and vitamin/mineral/dietary supplements. This list must include the name, dosages, frequency, and route of administration for each drug.

Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 92002, 92004, 92012, 92014, 92507, 92508, 92526, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92547, 92548, 92550, 92557, 92567, 92568, 92570, 92585, 92588, 92626, 96116, 96150, 96151, 96152, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97532, 97802, 97803, 97804, 98960, 98961, 98962, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99221, 99222, 99223, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99495, 99496, G0101, G0108, G0270, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8427 indicates that the patient’s medical record was updated with the current medications. Use exception code G8430 if you documented in the medical record that the patient is not eligible for a current list of medications being obtained and reviewed.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

  • Those who enrolled in Medicare for the first time during a performance period.
  • Those who have Medicare Part B allowed charges of $30,000 or less.
  • Those who have 100 or fewer Medicare Part B patients.
  • Those who are significantly participating in an Advanced Alternative Payment Model (APM).

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Incidental lung nodules are frequently not mentioned in hospital discharge summary

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Clinical question: How often are incidentally found pulmonary nodules and instructions for follow-up included in the discharge summary?

Background: Lung nodules are frequent incidental findings on imaging, but it is unclear whether patients are subsequently receiving the recommended follow-up.

Study design: Retrospective cohort study.

Setting: Single academic medical center in the United States.

Synopsis: The authors identified 7,173 patients who had undergone abdominal CT scans during their admission and reviewed charts of 402 patients who had incidentally found pulmonary nodules identified on the scans. For each of the patients, discharge summaries were evaluated to determine whether they made reference to the nodules and whether follow-up instructions were included. Of the 208 patients noted to have nodules requiring follow-up, only 48 (23%) had discharge summaries that mentioned the nodules. Factors associated with including the nodules in the discharge summary were the radiologist recommending further surveillance, radiologist including the nodule in the summary heading of the report, and being on a medical as opposed to a surgical service. The authors concluded that systems-based approaches to incidentally found lung nodules are needed to ensure adequate follow-up.

Bottom line: Incidentally found lung nodules are often not included in discharge documentation and therefore may not receive the recommended follow-up.

Citation: Bates R, Plooster C, Croghan I, et al. Incidental pulmonary nodules reported on CT abdominal imaging: Frequency and factors affecting inclusion in the hospital discharge summary. J Hosp Med. 2017;6:454-7.

Dr. Herscher is assistant professor, division of hospital medicine, Icahn School of Medicine of the Mount Sinai Health System.

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Clinical question: How often are incidentally found pulmonary nodules and instructions for follow-up included in the discharge summary?

Background: Lung nodules are frequent incidental findings on imaging, but it is unclear whether patients are subsequently receiving the recommended follow-up.

Study design: Retrospective cohort study.

Setting: Single academic medical center in the United States.

Synopsis: The authors identified 7,173 patients who had undergone abdominal CT scans during their admission and reviewed charts of 402 patients who had incidentally found pulmonary nodules identified on the scans. For each of the patients, discharge summaries were evaluated to determine whether they made reference to the nodules and whether follow-up instructions were included. Of the 208 patients noted to have nodules requiring follow-up, only 48 (23%) had discharge summaries that mentioned the nodules. Factors associated with including the nodules in the discharge summary were the radiologist recommending further surveillance, radiologist including the nodule in the summary heading of the report, and being on a medical as opposed to a surgical service. The authors concluded that systems-based approaches to incidentally found lung nodules are needed to ensure adequate follow-up.

Bottom line: Incidentally found lung nodules are often not included in discharge documentation and therefore may not receive the recommended follow-up.

Citation: Bates R, Plooster C, Croghan I, et al. Incidental pulmonary nodules reported on CT abdominal imaging: Frequency and factors affecting inclusion in the hospital discharge summary. J Hosp Med. 2017;6:454-7.

Dr. Herscher is assistant professor, division of hospital medicine, Icahn School of Medicine of the Mount Sinai Health System.

 

Clinical question: How often are incidentally found pulmonary nodules and instructions for follow-up included in the discharge summary?

Background: Lung nodules are frequent incidental findings on imaging, but it is unclear whether patients are subsequently receiving the recommended follow-up.

Study design: Retrospective cohort study.

Setting: Single academic medical center in the United States.

Synopsis: The authors identified 7,173 patients who had undergone abdominal CT scans during their admission and reviewed charts of 402 patients who had incidentally found pulmonary nodules identified on the scans. For each of the patients, discharge summaries were evaluated to determine whether they made reference to the nodules and whether follow-up instructions were included. Of the 208 patients noted to have nodules requiring follow-up, only 48 (23%) had discharge summaries that mentioned the nodules. Factors associated with including the nodules in the discharge summary were the radiologist recommending further surveillance, radiologist including the nodule in the summary heading of the report, and being on a medical as opposed to a surgical service. The authors concluded that systems-based approaches to incidentally found lung nodules are needed to ensure adequate follow-up.

Bottom line: Incidentally found lung nodules are often not included in discharge documentation and therefore may not receive the recommended follow-up.

Citation: Bates R, Plooster C, Croghan I, et al. Incidental pulmonary nodules reported on CT abdominal imaging: Frequency and factors affecting inclusion in the hospital discharge summary. J Hosp Med. 2017;6:454-7.

Dr. Herscher is assistant professor, division of hospital medicine, Icahn School of Medicine of the Mount Sinai Health System.

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Results support using MTD of HU in kids with SCA

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Results support using MTD of HU in kids with SCA

Research Hospital
Jeremie Estepp, MD, examines a patient Photo from Seth Dixon/ St. Jude Children’s

Dosing of hydroxyurea (HU) in young patients with sickle cell anemia (SCA) should target a fetal hemoglobin (HbF) level above 20%, according to researchers.

Their study, HUSTLE, showed that children and adolescents who received a maximum tolerated dose (MTD) of HU were able to achieve HbF levels above 20%.

And patients who achieved such HbF levels had a significantly lower risk of hospitalization for any reason, including vaso-occlusive crisis, acute chest syndrome, and fever.

Jeremie Estepp, MD, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues reported these results in the American Journal of Hematology.

“Our analysis showed that, using this approach, hospitalizations for the average patient fell to less than 1 every couple of years rather than 4 to 6 annually,” Dr Estepp said. “This frees children from the fevers, pain, and other symptoms of this disease and gives them and their families more chances to enjoy childhood and adolescence.”

The study enrolled 230 SCA patients. Most had the HbSS genotype (n=214; 93%), although 7% (n=16) had HbSb0 thalassemia. The patients’ median age at HU initiation was 7.4 years (range, 6 months to 17.9 years). The mean HbF level at enrollment was 9.7%, and the median was 7.9% (range, 1.0-32.9%).

The researchers used a dose-escalation approach to determine the MTD of HU for each of the patients in this study. The MTD was defined by an absolute neutrophil count of 2000-4000 x 106/L or the presence of hematologic toxicity. The maximum absolute dose was 35 mg/kg/day or 2000 mg/day (whichever came first).

The mean daily dose of HU at the MTD was 26.7 mg/kg/day, and the median was 28.0 mg/kg/day (range, 13.0 to 35.0 mg/kg/day).

Three-quarters of patients (75.2%, 173/230) attained the MTD at the time of data censoring. Patients were followed for up to 4 years after study entry.

As far as treatment compliance, there were complete medication dispensation records available for 96% (220/230) of patients. And the patients were in possession of HU a mean of 93.6% of the time.

The researchers found that administering HU at the MTD resulted in a mean HbF of 26.7% and a median of 21.7% (interquartile range, 16.2% to 27.8%).

And the odds of being hospitalized were higher when a patient’s HbF level was less than 21%. The odds ratios for hospitalization were as follows:

  • 4.1 for fever
  • 2.6 for acute chest syndrome
  • 2.2 for vaso-occlusive crisis
  • 2.1 for any reason.

“These results support a hydroxyurea dosing strategy designed to produce fetal hemoglobin levels that exceed 20% in an effort to decrease hospitalization of children with sickle cell disease,” Dr Estepp said.

He and his colleagues are now conducting a multicenter trial to determine if toddlers with SCA would benefit from a similar dosing strategy or would respond better to a standard dose.

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Research Hospital
Jeremie Estepp, MD, examines a patient Photo from Seth Dixon/ St. Jude Children’s

Dosing of hydroxyurea (HU) in young patients with sickle cell anemia (SCA) should target a fetal hemoglobin (HbF) level above 20%, according to researchers.

Their study, HUSTLE, showed that children and adolescents who received a maximum tolerated dose (MTD) of HU were able to achieve HbF levels above 20%.

And patients who achieved such HbF levels had a significantly lower risk of hospitalization for any reason, including vaso-occlusive crisis, acute chest syndrome, and fever.

Jeremie Estepp, MD, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues reported these results in the American Journal of Hematology.

“Our analysis showed that, using this approach, hospitalizations for the average patient fell to less than 1 every couple of years rather than 4 to 6 annually,” Dr Estepp said. “This frees children from the fevers, pain, and other symptoms of this disease and gives them and their families more chances to enjoy childhood and adolescence.”

The study enrolled 230 SCA patients. Most had the HbSS genotype (n=214; 93%), although 7% (n=16) had HbSb0 thalassemia. The patients’ median age at HU initiation was 7.4 years (range, 6 months to 17.9 years). The mean HbF level at enrollment was 9.7%, and the median was 7.9% (range, 1.0-32.9%).

The researchers used a dose-escalation approach to determine the MTD of HU for each of the patients in this study. The MTD was defined by an absolute neutrophil count of 2000-4000 x 106/L or the presence of hematologic toxicity. The maximum absolute dose was 35 mg/kg/day or 2000 mg/day (whichever came first).

The mean daily dose of HU at the MTD was 26.7 mg/kg/day, and the median was 28.0 mg/kg/day (range, 13.0 to 35.0 mg/kg/day).

Three-quarters of patients (75.2%, 173/230) attained the MTD at the time of data censoring. Patients were followed for up to 4 years after study entry.

As far as treatment compliance, there were complete medication dispensation records available for 96% (220/230) of patients. And the patients were in possession of HU a mean of 93.6% of the time.

The researchers found that administering HU at the MTD resulted in a mean HbF of 26.7% and a median of 21.7% (interquartile range, 16.2% to 27.8%).

And the odds of being hospitalized were higher when a patient’s HbF level was less than 21%. The odds ratios for hospitalization were as follows:

  • 4.1 for fever
  • 2.6 for acute chest syndrome
  • 2.2 for vaso-occlusive crisis
  • 2.1 for any reason.

“These results support a hydroxyurea dosing strategy designed to produce fetal hemoglobin levels that exceed 20% in an effort to decrease hospitalization of children with sickle cell disease,” Dr Estepp said.

He and his colleagues are now conducting a multicenter trial to determine if toddlers with SCA would benefit from a similar dosing strategy or would respond better to a standard dose.

Research Hospital
Jeremie Estepp, MD, examines a patient Photo from Seth Dixon/ St. Jude Children’s

Dosing of hydroxyurea (HU) in young patients with sickle cell anemia (SCA) should target a fetal hemoglobin (HbF) level above 20%, according to researchers.

Their study, HUSTLE, showed that children and adolescents who received a maximum tolerated dose (MTD) of HU were able to achieve HbF levels above 20%.

And patients who achieved such HbF levels had a significantly lower risk of hospitalization for any reason, including vaso-occlusive crisis, acute chest syndrome, and fever.

Jeremie Estepp, MD, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues reported these results in the American Journal of Hematology.

“Our analysis showed that, using this approach, hospitalizations for the average patient fell to less than 1 every couple of years rather than 4 to 6 annually,” Dr Estepp said. “This frees children from the fevers, pain, and other symptoms of this disease and gives them and their families more chances to enjoy childhood and adolescence.”

The study enrolled 230 SCA patients. Most had the HbSS genotype (n=214; 93%), although 7% (n=16) had HbSb0 thalassemia. The patients’ median age at HU initiation was 7.4 years (range, 6 months to 17.9 years). The mean HbF level at enrollment was 9.7%, and the median was 7.9% (range, 1.0-32.9%).

The researchers used a dose-escalation approach to determine the MTD of HU for each of the patients in this study. The MTD was defined by an absolute neutrophil count of 2000-4000 x 106/L or the presence of hematologic toxicity. The maximum absolute dose was 35 mg/kg/day or 2000 mg/day (whichever came first).

The mean daily dose of HU at the MTD was 26.7 mg/kg/day, and the median was 28.0 mg/kg/day (range, 13.0 to 35.0 mg/kg/day).

Three-quarters of patients (75.2%, 173/230) attained the MTD at the time of data censoring. Patients were followed for up to 4 years after study entry.

As far as treatment compliance, there were complete medication dispensation records available for 96% (220/230) of patients. And the patients were in possession of HU a mean of 93.6% of the time.

The researchers found that administering HU at the MTD resulted in a mean HbF of 26.7% and a median of 21.7% (interquartile range, 16.2% to 27.8%).

And the odds of being hospitalized were higher when a patient’s HbF level was less than 21%. The odds ratios for hospitalization were as follows:

  • 4.1 for fever
  • 2.6 for acute chest syndrome
  • 2.2 for vaso-occlusive crisis
  • 2.1 for any reason.

“These results support a hydroxyurea dosing strategy designed to produce fetal hemoglobin levels that exceed 20% in an effort to decrease hospitalization of children with sickle cell disease,” Dr Estepp said.

He and his colleagues are now conducting a multicenter trial to determine if toddlers with SCA would benefit from a similar dosing strategy or would respond better to a standard dose.

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Tick, Tick, Boom

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1. A 16-year-old boy presents with a skin ulcer on the dorsum of his hand and swollen glands in the proximal axilla. He works as a camp counselor in South Dakota, leading nature walks and teaching the children to care for animals, including the camp’s rabbits. Several weeks ago, he developed a fever of 103°F, fatigue, and body aches, followed by the appearance of the skin lesion.

Source: Science Source [Image Number BB8283]

 

Diagnosis: Tularemia—also called rabbit fever or deer fly fever—is caused by the bacterium Francisella tularensis. It is an insect-borne pathogen of rabbits, squirrels, and other rodents, most commonly found in the western United States and Russia. Symptoms vary by mechanism of exposure but include skin ulcers; irritation and inflammation of the eye; sore throat, mouth ulcers, and tonsillitis; lung involvement with cough, chest pain, and difficulty breathing; and swelling of regional lymph nodes. Tularemia can be successfully treated with antibiotics.

For more information, see “Pneumonic Tularemia Presenting With a Vesicular Eruption.” Cutis. 2015;95(4):E17-E18.

 

 

2. About 10-12 days after hiking in the Appalachian Mountains, this young woman presents with a 7-in circular rash on her upper back that is slightly warm to the touch. She denies fever, pruritus, and joint pain.

Source: Paul Whitten / Science Source [Image number BZ4987]

 

Diagnosis: Lyme disease is the most common tick-borne illness in the United States, with more than 25,000 confirmed cases in 2014. It is concentrated mostly in the northeast and upper Midwest, although in 2014, only five states (Colorado, Hawaii, Louisiana, New Mexico, and Oklahoma) reported no incidence. Lyme disease is caused by Borrelia burgdorferi, which is transmitted to humans by the Ixodes tick.

For more information, see “Beyond the bull's eye: Recognizing Lyme disease.” J Fam Pract. 2016;65(6):373-379.

 

 

3. A 42-year-old Native American farmer in Arizona has a reddish purple petechial rash on his ankles and feet. Upon questioning, he reports that about three weeks ago he had a slight fever with headache and malaise. Then, last week, he noticed small, flat, pink, nonitchy macules on his wrists, forearms, and ankles; they are now spreading to the trunk.

 

Source: CDC
[https://www.cdc.gov/rmsf/symptoms/index.html]

Diagnosis: Rocky Mountain spotted fever, now reported to the CDC as spotted fever rickettsiosis, is a tick-borne illness caused by the gram-negative intracellular bacterium Rickettsia rickettsia. It is endemic in the Southeastern and South Central United States. Most cases occur between April and September, coinciding with the active season of the vector tick species. Early diagnosis is critical because untreated RMSF may progress to fulminant systemic illness.

For more information, see “Fever and Rash in a 3-Year-Old Girl: Rocky Mountain Spotted Fever.” Cutis. 2002;70(3):165-168.

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1. A 16-year-old boy presents with a skin ulcer on the dorsum of his hand and swollen glands in the proximal axilla. He works as a camp counselor in South Dakota, leading nature walks and teaching the children to care for animals, including the camp’s rabbits. Several weeks ago, he developed a fever of 103°F, fatigue, and body aches, followed by the appearance of the skin lesion.

Source: Science Source [Image Number BB8283]

 

Diagnosis: Tularemia—also called rabbit fever or deer fly fever—is caused by the bacterium Francisella tularensis. It is an insect-borne pathogen of rabbits, squirrels, and other rodents, most commonly found in the western United States and Russia. Symptoms vary by mechanism of exposure but include skin ulcers; irritation and inflammation of the eye; sore throat, mouth ulcers, and tonsillitis; lung involvement with cough, chest pain, and difficulty breathing; and swelling of regional lymph nodes. Tularemia can be successfully treated with antibiotics.

For more information, see “Pneumonic Tularemia Presenting With a Vesicular Eruption.” Cutis. 2015;95(4):E17-E18.

 

 

2. About 10-12 days after hiking in the Appalachian Mountains, this young woman presents with a 7-in circular rash on her upper back that is slightly warm to the touch. She denies fever, pruritus, and joint pain.

Source: Paul Whitten / Science Source [Image number BZ4987]

 

Diagnosis: Lyme disease is the most common tick-borne illness in the United States, with more than 25,000 confirmed cases in 2014. It is concentrated mostly in the northeast and upper Midwest, although in 2014, only five states (Colorado, Hawaii, Louisiana, New Mexico, and Oklahoma) reported no incidence. Lyme disease is caused by Borrelia burgdorferi, which is transmitted to humans by the Ixodes tick.

For more information, see “Beyond the bull's eye: Recognizing Lyme disease.” J Fam Pract. 2016;65(6):373-379.

 

 

3. A 42-year-old Native American farmer in Arizona has a reddish purple petechial rash on his ankles and feet. Upon questioning, he reports that about three weeks ago he had a slight fever with headache and malaise. Then, last week, he noticed small, flat, pink, nonitchy macules on his wrists, forearms, and ankles; they are now spreading to the trunk.

 

Source: CDC
[https://www.cdc.gov/rmsf/symptoms/index.html]

Diagnosis: Rocky Mountain spotted fever, now reported to the CDC as spotted fever rickettsiosis, is a tick-borne illness caused by the gram-negative intracellular bacterium Rickettsia rickettsia. It is endemic in the Southeastern and South Central United States. Most cases occur between April and September, coinciding with the active season of the vector tick species. Early diagnosis is critical because untreated RMSF may progress to fulminant systemic illness.

For more information, see “Fever and Rash in a 3-Year-Old Girl: Rocky Mountain Spotted Fever.” Cutis. 2002;70(3):165-168.

1. A 16-year-old boy presents with a skin ulcer on the dorsum of his hand and swollen glands in the proximal axilla. He works as a camp counselor in South Dakota, leading nature walks and teaching the children to care for animals, including the camp’s rabbits. Several weeks ago, he developed a fever of 103°F, fatigue, and body aches, followed by the appearance of the skin lesion.

Source: Science Source [Image Number BB8283]

 

Diagnosis: Tularemia—also called rabbit fever or deer fly fever—is caused by the bacterium Francisella tularensis. It is an insect-borne pathogen of rabbits, squirrels, and other rodents, most commonly found in the western United States and Russia. Symptoms vary by mechanism of exposure but include skin ulcers; irritation and inflammation of the eye; sore throat, mouth ulcers, and tonsillitis; lung involvement with cough, chest pain, and difficulty breathing; and swelling of regional lymph nodes. Tularemia can be successfully treated with antibiotics.

For more information, see “Pneumonic Tularemia Presenting With a Vesicular Eruption.” Cutis. 2015;95(4):E17-E18.

 

 

2. About 10-12 days after hiking in the Appalachian Mountains, this young woman presents with a 7-in circular rash on her upper back that is slightly warm to the touch. She denies fever, pruritus, and joint pain.

Source: Paul Whitten / Science Source [Image number BZ4987]

 

Diagnosis: Lyme disease is the most common tick-borne illness in the United States, with more than 25,000 confirmed cases in 2014. It is concentrated mostly in the northeast and upper Midwest, although in 2014, only five states (Colorado, Hawaii, Louisiana, New Mexico, and Oklahoma) reported no incidence. Lyme disease is caused by Borrelia burgdorferi, which is transmitted to humans by the Ixodes tick.

For more information, see “Beyond the bull's eye: Recognizing Lyme disease.” J Fam Pract. 2016;65(6):373-379.

 

 

3. A 42-year-old Native American farmer in Arizona has a reddish purple petechial rash on his ankles and feet. Upon questioning, he reports that about three weeks ago he had a slight fever with headache and malaise. Then, last week, he noticed small, flat, pink, nonitchy macules on his wrists, forearms, and ankles; they are now spreading to the trunk.

 

Source: CDC
[https://www.cdc.gov/rmsf/symptoms/index.html]

Diagnosis: Rocky Mountain spotted fever, now reported to the CDC as spotted fever rickettsiosis, is a tick-borne illness caused by the gram-negative intracellular bacterium Rickettsia rickettsia. It is endemic in the Southeastern and South Central United States. Most cases occur between April and September, coinciding with the active season of the vector tick species. Early diagnosis is critical because untreated RMSF may progress to fulminant systemic illness.

For more information, see “Fever and Rash in a 3-Year-Old Girl: Rocky Mountain Spotted Fever.” Cutis. 2002;70(3):165-168.

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VIDEO: ERAS for minimally invasive surgery

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Stacy A. Brethauer, MD, FACS, discusses the role of Enhanced Recovery After Surgery (ERAS) in minimally invasive surgical procedures. The goal of the ERAS approach is to minimize surgical stress on the patient, reduce length of stay, and reduce the use of opioids in the recovery phase. Dr. Brethauer discusses a pilot program, the Energy project, which will be conducted in more than 30 institutions for a year to look at an ERAS protocol designed to work with minimally invasive surgical procedures.

 

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Stacy A. Brethauer, MD, FACS, discusses the role of Enhanced Recovery After Surgery (ERAS) in minimally invasive surgical procedures. The goal of the ERAS approach is to minimize surgical stress on the patient, reduce length of stay, and reduce the use of opioids in the recovery phase. Dr. Brethauer discusses a pilot program, the Energy project, which will be conducted in more than 30 institutions for a year to look at an ERAS protocol designed to work with minimally invasive surgical procedures.

 

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Stacy A. Brethauer, MD, FACS, discusses the role of Enhanced Recovery After Surgery (ERAS) in minimally invasive surgical procedures. The goal of the ERAS approach is to minimize surgical stress on the patient, reduce length of stay, and reduce the use of opioids in the recovery phase. Dr. Brethauer discusses a pilot program, the Energy project, which will be conducted in more than 30 institutions for a year to look at an ERAS protocol designed to work with minimally invasive surgical procedures.

 

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Blindness linked to HCQ use rare in rheumatic patients

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– Out of a cohort of nearly 2,900 rheumatic patients, none developed blindness attributable to toxic maculopathy from using hydroxychloroquine, in a single-center retrospective study.

“That’s very reassuring,” lead study author Dilpreet K. Singh, MD, said in an interview at the annual meeting of the American College of Rheumatology. “It’s still important to be vigilant with our screening and also to take note of the hydroxychloroquine dose that they’re on, because a lot of our patients have been on hydroxychloroquine for 10 or 15 years and there may not have been a dose adjustment. It’s also important to focus on the patients’ comorbidities and get them under better control.”

Doug Brunk/Frontline Medical News
Dr. Dilpreet K. Singh
Dr. Singh, a rheumatology fellow at MetroHealth Medical Center, which is affiliated with Case Western Reserve University, Cleveland, noted that long-term use of hydroxychloroquine (HCQ) has been associated with retinopathy in a daily and cumulative dose-dependent manner by weight. Less frequently, bull’s eye maculopathy may occur, which is reversible and can lead to blindness, yet little is known about the incidence of this condition. Recent guidelines from the American Academy of Ophthalmology recommend a maximum daily HCQ dose of 5.0 mg/kg real weight and emphasize annual screening for early detection of retinal toxicity.

In an effort to assess the prevalence of blindness in a cohort of rheumatic patients and to identify the characteristics and comorbidities of those with HCQ retinal toxicity, Dr. Singh and her associates retrospectively evaluated 2,898 patients at MetroHealth Medical Center between January 1999 and August of 2017 with diagnoses of rheumatoid arthritis, inflammatory polyarthritis, systemic lupus erythematosus, subacute cutaneous lupus, and discoid lupus erythematosus who had a prescription written for HCQ.

In all, 31 had a diagnosis of “blindness” or “toxic maculopathy,” and these cases were further assessed for patient demographics, comorbidities, use of tamoxifen, weight and dose at initiation and discontinuation of HCQ, and duration of HCQ. Nearly 70% of these patients had hypertension, about 60% had chronic kidney disease, and 35% had cataracts. The researchers confirmed that in each of the cases the blindness was not caused by HCQ ocular toxicity, but instead by stroke, preexisting macular disease, diabetic retinopathy, hypertensive retinopathy, or cataracts.

Only 3 of the 31 patients were found to have HCQ retinal toxicity, each without blindness or change in vision. Two patients had bull’s-eye maculopathy and one had HCQ toxic maculopathy. Each of the three patients had received HCQ for more than 18 years at doses that ranged from 6.3 to 8.2 mg/kg based on documented weight, and none had functional vision loss at diagnosis.

“It’s reassuring to know that there’s a very small percentage of patients that will have HCQ-related toxicity,” Dr. Singh concluded. “We should also be focusing on the comorbidities [such as] diabetes, hypertension, and stroke-related vision loss that are common in our population of rheumatic patients, because these are contributing to visual impairment and blindness.”

She reported having no disclosures.

[email protected]
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– Out of a cohort of nearly 2,900 rheumatic patients, none developed blindness attributable to toxic maculopathy from using hydroxychloroquine, in a single-center retrospective study.

“That’s very reassuring,” lead study author Dilpreet K. Singh, MD, said in an interview at the annual meeting of the American College of Rheumatology. “It’s still important to be vigilant with our screening and also to take note of the hydroxychloroquine dose that they’re on, because a lot of our patients have been on hydroxychloroquine for 10 or 15 years and there may not have been a dose adjustment. It’s also important to focus on the patients’ comorbidities and get them under better control.”

Doug Brunk/Frontline Medical News
Dr. Dilpreet K. Singh
Dr. Singh, a rheumatology fellow at MetroHealth Medical Center, which is affiliated with Case Western Reserve University, Cleveland, noted that long-term use of hydroxychloroquine (HCQ) has been associated with retinopathy in a daily and cumulative dose-dependent manner by weight. Less frequently, bull’s eye maculopathy may occur, which is reversible and can lead to blindness, yet little is known about the incidence of this condition. Recent guidelines from the American Academy of Ophthalmology recommend a maximum daily HCQ dose of 5.0 mg/kg real weight and emphasize annual screening for early detection of retinal toxicity.

In an effort to assess the prevalence of blindness in a cohort of rheumatic patients and to identify the characteristics and comorbidities of those with HCQ retinal toxicity, Dr. Singh and her associates retrospectively evaluated 2,898 patients at MetroHealth Medical Center between January 1999 and August of 2017 with diagnoses of rheumatoid arthritis, inflammatory polyarthritis, systemic lupus erythematosus, subacute cutaneous lupus, and discoid lupus erythematosus who had a prescription written for HCQ.

In all, 31 had a diagnosis of “blindness” or “toxic maculopathy,” and these cases were further assessed for patient demographics, comorbidities, use of tamoxifen, weight and dose at initiation and discontinuation of HCQ, and duration of HCQ. Nearly 70% of these patients had hypertension, about 60% had chronic kidney disease, and 35% had cataracts. The researchers confirmed that in each of the cases the blindness was not caused by HCQ ocular toxicity, but instead by stroke, preexisting macular disease, diabetic retinopathy, hypertensive retinopathy, or cataracts.

Only 3 of the 31 patients were found to have HCQ retinal toxicity, each without blindness or change in vision. Two patients had bull’s-eye maculopathy and one had HCQ toxic maculopathy. Each of the three patients had received HCQ for more than 18 years at doses that ranged from 6.3 to 8.2 mg/kg based on documented weight, and none had functional vision loss at diagnosis.

“It’s reassuring to know that there’s a very small percentage of patients that will have HCQ-related toxicity,” Dr. Singh concluded. “We should also be focusing on the comorbidities [such as] diabetes, hypertension, and stroke-related vision loss that are common in our population of rheumatic patients, because these are contributing to visual impairment and blindness.”

She reported having no disclosures.

[email protected]

– Out of a cohort of nearly 2,900 rheumatic patients, none developed blindness attributable to toxic maculopathy from using hydroxychloroquine, in a single-center retrospective study.

“That’s very reassuring,” lead study author Dilpreet K. Singh, MD, said in an interview at the annual meeting of the American College of Rheumatology. “It’s still important to be vigilant with our screening and also to take note of the hydroxychloroquine dose that they’re on, because a lot of our patients have been on hydroxychloroquine for 10 or 15 years and there may not have been a dose adjustment. It’s also important to focus on the patients’ comorbidities and get them under better control.”

Doug Brunk/Frontline Medical News
Dr. Dilpreet K. Singh
Dr. Singh, a rheumatology fellow at MetroHealth Medical Center, which is affiliated with Case Western Reserve University, Cleveland, noted that long-term use of hydroxychloroquine (HCQ) has been associated with retinopathy in a daily and cumulative dose-dependent manner by weight. Less frequently, bull’s eye maculopathy may occur, which is reversible and can lead to blindness, yet little is known about the incidence of this condition. Recent guidelines from the American Academy of Ophthalmology recommend a maximum daily HCQ dose of 5.0 mg/kg real weight and emphasize annual screening for early detection of retinal toxicity.

In an effort to assess the prevalence of blindness in a cohort of rheumatic patients and to identify the characteristics and comorbidities of those with HCQ retinal toxicity, Dr. Singh and her associates retrospectively evaluated 2,898 patients at MetroHealth Medical Center between January 1999 and August of 2017 with diagnoses of rheumatoid arthritis, inflammatory polyarthritis, systemic lupus erythematosus, subacute cutaneous lupus, and discoid lupus erythematosus who had a prescription written for HCQ.

In all, 31 had a diagnosis of “blindness” or “toxic maculopathy,” and these cases were further assessed for patient demographics, comorbidities, use of tamoxifen, weight and dose at initiation and discontinuation of HCQ, and duration of HCQ. Nearly 70% of these patients had hypertension, about 60% had chronic kidney disease, and 35% had cataracts. The researchers confirmed that in each of the cases the blindness was not caused by HCQ ocular toxicity, but instead by stroke, preexisting macular disease, diabetic retinopathy, hypertensive retinopathy, or cataracts.

Only 3 of the 31 patients were found to have HCQ retinal toxicity, each without blindness or change in vision. Two patients had bull’s-eye maculopathy and one had HCQ toxic maculopathy. Each of the three patients had received HCQ for more than 18 years at doses that ranged from 6.3 to 8.2 mg/kg based on documented weight, and none had functional vision loss at diagnosis.

“It’s reassuring to know that there’s a very small percentage of patients that will have HCQ-related toxicity,” Dr. Singh concluded. “We should also be focusing on the comorbidities [such as] diabetes, hypertension, and stroke-related vision loss that are common in our population of rheumatic patients, because these are contributing to visual impairment and blindness.”

She reported having no disclosures.

[email protected]
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Key clinical point: The incidence of blindness due to hydroxychloroquine toxicity is very low.

Major finding: No patients developed blindness attributable to toxic maculopathy from using hydroxychloroquine.

Study details: A single-center retrospective study of 2,898 rheumatic patients.

Disclosures: Dr. Singh reported having no disclosures.

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