Heart failure remains one of the deadliest chronic medical conditions, with 5-year mortality rates approaching 50%, and is the most common diagnosis for adults aged 65 years and older who are admitted to the hospital, according to Albert J. Hicks III, MD.

Dr. Hicks, a cardiologist at Baylor Scott & White Health in Temple, Tex., will discuss the latest challenges and hottest topics surrounding heart failure in the “Updates in Heart Failure” session on Monday, at HM19.

The growth of an aging population in the United States further emphasizes the importance of heart failure as a topic of interest to clinicians, Dr. Hicks said in an interview. He noted that heart failure is the highest medical expenditure for Medicare, and estimates suggest the condition will cost the U.S. health care system $30 billion by the year 2030, he said. With these numbers in mind, the timing of referring patients to an advanced heart failure team is a key issue.

But the timing of referral for advanced care is just one of the hot topics on the agenda for the “Updates in Heart Failure” session, Dr. Hicks said. Other topics include heart failure epidemiology (incidence, prevalence, morbidity, mortality, and disparities); economics of heart failure (burden of care on the U.S. health care system); heart failure hospitalizations and readmissions (risk factors, comorbidities, patient compliance issues); pathophysiology (why heart failure is so deadly); signs and symptoms of heart failure (how to recognize them); treatment of stage C heart failure, with a review of old and new drugs and devices; and treatment of stage D heart failure, including palliative care, mechanical circulatory support, and heart transplantation.

Dr. Hicks’ primary goal for the session is to “increase awareness of the high mortality associated with a heart failure diagnosis,” he said. He also hopes to educate hospitalists about the latest medications, devices, and resources for heart failure patients and to give them the tools and knowledge to help reduce morbidity and mortality in their heart failure patients.

Session attendees also will benefit from Dr. Hicks’ practical advice on identifying warning signs that indicate a heart failure patient may need a medical assist device or a heart transplant and on encouraging early referral of heart failure patients to advanced heart failure specialists before irreversible end-organ damage occurs.

Dr. Hicks hypothesized that the high mortality associated with a heart failure diagnosis, hospital readmission, and late referral will generate the liveliest discussion because issues of costs and resources continue to evolve.

His take-home message: “Early recognition and referral of heart failure patients to a heart failure cardiologist can improve patient costs, morbidity, and survival.

Dr. Hicks had no relevant financial conflicts to disclose.

Updates in Heart Failure
Monday, 2:00-2:40 p.m.
Woodrow Wilson

Heart failure remains one of the deadliest chronic medical conditions, with 5-year mortality rates approaching 50%, and is the most common diagnosis for adults aged 65 years and older who are admitted to the hospital, according to Albert J. Hicks III, MD.

Dr. Hicks, a cardiologist at Baylor Scott & White Health in Temple, Tex., will discuss the latest challenges and hottest topics surrounding heart failure in the “Updates in Heart Failure” session on Monday, at HM19.

The growth of an aging population in the United States further emphasizes the importance of heart failure as a topic of interest to clinicians, Dr. Hicks said in an interview. He noted that heart failure is the highest medical expenditure for Medicare, and estimates suggest the condition will cost the U.S. health care system $30 billion by the year 2030, he said. With these numbers in mind, the timing of referring patients to an advanced heart failure team is a key issue.

But the timing of referral for advanced care is just one of the hot topics on the agenda for the “Updates in Heart Failure” session, Dr. Hicks said. Other topics include heart failure epidemiology (incidence, prevalence, morbidity, mortality, and disparities); economics of heart failure (burden of care on the U.S. health care system); heart failure hospitalizations and readmissions (risk factors, comorbidities, patient compliance issues); pathophysiology (why heart failure is so deadly); signs and symptoms of heart failure (how to recognize them); treatment of stage C heart failure, with a review of old and new drugs and devices; and treatment of stage D heart failure, including palliative care, mechanical circulatory support, and heart transplantation.

Dr. Hicks’ primary goal for the session is to “increase awareness of the high mortality associated with a heart failure diagnosis,” he said. He also hopes to educate hospitalists about the latest medications, devices, and resources for heart failure patients and to give them the tools and knowledge to help reduce morbidity and mortality in their heart failure patients.

Session attendees also will benefit from Dr. Hicks’ practical advice on identifying warning signs that indicate a heart failure patient may need a medical assist device or a heart transplant and on encouraging early referral of heart failure patients to advanced heart failure specialists before irreversible end-organ damage occurs.

Dr. Hicks hypothesized that the high mortality associated with a heart failure diagnosis, hospital readmission, and late referral will generate the liveliest discussion because issues of costs and resources continue to evolve.

His take-home message: “Early recognition and referral of heart failure patients to a heart failure cardiologist can improve patient costs, morbidity, and survival.

Dr. Hicks had no relevant financial conflicts to disclose.

Updates in Heart Failure
Monday, 2:00-2:40 p.m.
Woodrow Wilson

Heart failure remains one of the deadliest chronic medical conditions, with 5-year mortality rates approaching 50%, and is the most common diagnosis for adults aged 65 years and older who are admitted to the hospital, according to Albert J. Hicks III, MD.

Dr. Hicks, a cardiologist at Baylor Scott & White Health in Temple, Tex., will discuss the latest challenges and hottest topics surrounding heart failure in the “Updates in Heart Failure” session on Monday, at HM19.

The growth of an aging population in the United States further emphasizes the importance of heart failure as a topic of interest to clinicians, Dr. Hicks said in an interview. He noted that heart failure is the highest medical expenditure for Medicare, and estimates suggest the condition will cost the U.S. health care system $30 billion by the year 2030, he said. With these numbers in mind, the timing of referring patients to an advanced heart failure team is a key issue.

But the timing of referral for advanced care is just one of the hot topics on the agenda for the “Updates in Heart Failure” session, Dr. Hicks said. Other topics include heart failure epidemiology (incidence, prevalence, morbidity, mortality, and disparities); economics of heart failure (burden of care on the U.S. health care system); heart failure hospitalizations and readmissions (risk factors, comorbidities, patient compliance issues); pathophysiology (why heart failure is so deadly); signs and symptoms of heart failure (how to recognize them); treatment of stage C heart failure, with a review of old and new drugs and devices; and treatment of stage D heart failure, including palliative care, mechanical circulatory support, and heart transplantation.

Dr. Hicks’ primary goal for the session is to “increase awareness of the high mortality associated with a heart failure diagnosis,” he said. He also hopes to educate hospitalists about the latest medications, devices, and resources for heart failure patients and to give them the tools and knowledge to help reduce morbidity and mortality in their heart failure patients.

Session attendees also will benefit from Dr. Hicks’ practical advice on identifying warning signs that indicate a heart failure patient may need a medical assist device or a heart transplant and on encouraging early referral of heart failure patients to advanced heart failure specialists before irreversible end-organ damage occurs.

Dr. Hicks hypothesized that the high mortality associated with a heart failure diagnosis, hospital readmission, and late referral will generate the liveliest discussion because issues of costs and resources continue to evolve.

His take-home message: “Early recognition and referral of heart failure patients to a heart failure cardiologist can improve patient costs, morbidity, and survival.

Dr. Hicks had no relevant financial conflicts to disclose.

Updates in Heart Failure
Monday, 2:00-2:40 p.m.
Woodrow Wilson

It’s taken 2 years for family members to convince this 50-year-old black woman to consult dermatology about dark circles on her arms and trunk. The asymptomatic lesions were only faintly discolored at manifestation but have darkened with each recurrence. The 6 lesions she currently has are in the exact locations they originally manifested in.

Convinced she had “ringworm,” the patient tried several different antifungal creams, to no avail. Then her primary care provider prescribed a 2-month course of oral antifungal medication (terbinafine)—again, with no change to the lesions.

The patient is otherwise healthy except for osteoarthritis, for which she takes ibuprofen (800 mg 2 or 3 times a day). She denies any history of seizure, chronic urinary tract infection, or other chronic infection.

EXAMINATION
The 6 perfectly round, uniformly pigmented, dark brown macular lesions on the patient’s arms and trunk range from 2 to 5 cm in diameter. A faint, rusty brown halo can be seen around the periphery of the lesions, giving them a targetoid look. The surfaces of the lesions are completely smooth.

What’s the diagnosis?

DISCUSSION
The list of dark brown, round macules that come and go in the exact same locations is a short one—in fact, it only includes fixed drug eruption (FDE). This is a unique adverse reaction to one of several medications; common culprits are ibuprofen or other NSAIDs, aspirin, members of the sulfa family, penicillin, and several antiseizure medications.

The exact mechanism for this reaction is unknown, but it does appear to involve the localized production of cytokines. There is a range of morphologic presentations for FDE: some lesions are more targetoid than others; some are darker (especially in patients with darker skin) while others are more pink.

Furthermore, many patients develop additional lesions over time. A few, on the other hand, will reach a point at which they stop reacting to the offending product.

Of all the drugs causing FDE, sulfa-based products are among the more consistent offenders. Thus, we always ask about chronic urinary tract infections.

TAKE-HOME LEARNING POINTS

• Fixed drug eruptions (FDE) usually manifest with round, targetoid macules that are occasionally blistery.
• The lesions recur or darken with each “challenge” from the drug, which can be one of several potential offenders.
• The fact that the lesions keep recurring in the same location (ie, fixed) is pathognomic for FDE.
• FDE lesions can occur almost anywhere on the body—even on palms or soles.

It’s taken 2 years for family members to convince this 50-year-old black woman to consult dermatology about dark circles on her arms and trunk. The asymptomatic lesions were only faintly discolored at manifestation but have darkened with each recurrence. The 6 lesions she currently has are in the exact locations they originally manifested in.

Convinced she had “ringworm,” the patient tried several different antifungal creams, to no avail. Then her primary care provider prescribed a 2-month course of oral antifungal medication (terbinafine)—again, with no change to the lesions.

The patient is otherwise healthy except for osteoarthritis, for which she takes ibuprofen (800 mg 2 or 3 times a day). She denies any history of seizure, chronic urinary tract infection, or other chronic infection.

EXAMINATION
The 6 perfectly round, uniformly pigmented, dark brown macular lesions on the patient’s arms and trunk range from 2 to 5 cm in diameter. A faint, rusty brown halo can be seen around the periphery of the lesions, giving them a targetoid look. The surfaces of the lesions are completely smooth.

What’s the diagnosis?

DISCUSSION
The list of dark brown, round macules that come and go in the exact same locations is a short one—in fact, it only includes fixed drug eruption (FDE). This is a unique adverse reaction to one of several medications; common culprits are ibuprofen or other NSAIDs, aspirin, members of the sulfa family, penicillin, and several antiseizure medications.

The exact mechanism for this reaction is unknown, but it does appear to involve the localized production of cytokines. There is a range of morphologic presentations for FDE: some lesions are more targetoid than others; some are darker (especially in patients with darker skin) while others are more pink.

Furthermore, many patients develop additional lesions over time. A few, on the other hand, will reach a point at which they stop reacting to the offending product.

Of all the drugs causing FDE, sulfa-based products are among the more consistent offenders. Thus, we always ask about chronic urinary tract infections.

TAKE-HOME LEARNING POINTS

• Fixed drug eruptions (FDE) usually manifest with round, targetoid macules that are occasionally blistery.
• The lesions recur or darken with each “challenge” from the drug, which can be one of several potential offenders.
• The fact that the lesions keep recurring in the same location (ie, fixed) is pathognomic for FDE.
• FDE lesions can occur almost anywhere on the body—even on palms or soles.

It’s taken 2 years for family members to convince this 50-year-old black woman to consult dermatology about dark circles on her arms and trunk. The asymptomatic lesions were only faintly discolored at manifestation but have darkened with each recurrence. The 6 lesions she currently has are in the exact locations they originally manifested in.

Convinced she had “ringworm,” the patient tried several different antifungal creams, to no avail. Then her primary care provider prescribed a 2-month course of oral antifungal medication (terbinafine)—again, with no change to the lesions.

The patient is otherwise healthy except for osteoarthritis, for which she takes ibuprofen (800 mg 2 or 3 times a day). She denies any history of seizure, chronic urinary tract infection, or other chronic infection.

EXAMINATION
The 6 perfectly round, uniformly pigmented, dark brown macular lesions on the patient’s arms and trunk range from 2 to 5 cm in diameter. A faint, rusty brown halo can be seen around the periphery of the lesions, giving them a targetoid look. The surfaces of the lesions are completely smooth.

What’s the diagnosis?

DISCUSSION
The list of dark brown, round macules that come and go in the exact same locations is a short one—in fact, it only includes fixed drug eruption (FDE). This is a unique adverse reaction to one of several medications; common culprits are ibuprofen or other NSAIDs, aspirin, members of the sulfa family, penicillin, and several antiseizure medications.

The exact mechanism for this reaction is unknown, but it does appear to involve the localized production of cytokines. There is a range of morphologic presentations for FDE: some lesions are more targetoid than others; some are darker (especially in patients with darker skin) while others are more pink.

Furthermore, many patients develop additional lesions over time. A few, on the other hand, will reach a point at which they stop reacting to the offending product.

Of all the drugs causing FDE, sulfa-based products are among the more consistent offenders. Thus, we always ask about chronic urinary tract infections.

TAKE-HOME LEARNING POINTS

• Fixed drug eruptions (FDE) usually manifest with round, targetoid macules that are occasionally blistery.
• The lesions recur or darken with each “challenge” from the drug, which can be one of several potential offenders.
• The fact that the lesions keep recurring in the same location (ie, fixed) is pathognomic for FDE.
• FDE lesions can occur almost anywhere on the body—even on palms or soles.

SAN DIEGO – Patients who develop sepsis in the hospital appear to be in greater risk for mortality than those who bring it with them, a new study suggests. Patients with hospital-onset sepsis were twice as likely to die as those infected in the outside world.

MDedge News/Randy Dotinga

“There could be some differences in quality of care that explains the difference in mortality,” said study lead author Chanu Rhee, MD, assistant professor of population medicine at Harvard Medical School, Boston, in a presentation about the findings at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

In an interview, Dr. Rhee said researchers launched the study to gain a greater understanding of the epidemiology of sepsis in the hospital. They relied on a new Centers for Disease Control and Prevention definition of sepsis that is “enhancing the consistency of surveillance across hospitals and allowing more precise differentiation between hospital-onset versus community-onset sepsis.”

The study authors retrospectively tracked more than 2.2 million patients who were treated at 136 U.S. hospitals from 2009 to 2015. In general, hospital-onset sepsis was defined as patients who had a blood culture, initial antibiotic therapy, and organ dysfunction on their third day in the hospital or later.*

Of the patients, 83,600 had community-onset sepsis and 11,500 had hospital-onset sepsis. Those with sepsis were more likely to be men and have comorbidities such as cancer, congestive heart failure, diabetes, and renal disease.

Patients with hospital-onset sepsis had longer median lengths of stay (19 days) than the community-onset group (8 days) and the no-sepsis group (4 days). The hospital-onset group also had a greater likelihood of ICU admission (61%) than the community-onset (44%) and no-sepsis (9%) groups.

About 34% of those with hospital-onset sepsis died, compared with 17% of the community-onset group and 2% of the patients who didn’t have sepsis. After adjustment, those with hospital-onset sepsis were still more likely to have died (odds ratio, 2.1; 95% confidence interval, 2.0-2.2).

“Other studies have suggested that there may be delays in the recognition and care of patients who develop sepsis in the hospital as opposed to presenting to the hospital with sepsis,” Dr. Rhee said. “It is also possible that hospital-onset sepsis tends to be caused by organisms that are more virulent and resistant to antibiotics.”

Overall, he said, “our findings underscore the importance of targeting hospital-onset sepsis with surveillance, prevention, and quality improvement efforts.”

The study was funded by the CDC and the Agency for Healthcare Research and Quality. The authors reported no relevant disclosures.

SOURCE: Rhee C et al. CCC48, Abstract 29.

*Correction, 3/19/19: An earlier version of this article misstated the definition of sepsis.

SAN DIEGO – Patients who develop sepsis in the hospital appear to be in greater risk for mortality than those who bring it with them, a new study suggests. Patients with hospital-onset sepsis were twice as likely to die as those infected in the outside world.

MDedge News/Randy Dotinga

“There could be some differences in quality of care that explains the difference in mortality,” said study lead author Chanu Rhee, MD, assistant professor of population medicine at Harvard Medical School, Boston, in a presentation about the findings at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

In an interview, Dr. Rhee said researchers launched the study to gain a greater understanding of the epidemiology of sepsis in the hospital. They relied on a new Centers for Disease Control and Prevention definition of sepsis that is “enhancing the consistency of surveillance across hospitals and allowing more precise differentiation between hospital-onset versus community-onset sepsis.”

The study authors retrospectively tracked more than 2.2 million patients who were treated at 136 U.S. hospitals from 2009 to 2015. In general, hospital-onset sepsis was defined as patients who had a blood culture, initial antibiotic therapy, and organ dysfunction on their third day in the hospital or later.*

Of the patients, 83,600 had community-onset sepsis and 11,500 had hospital-onset sepsis. Those with sepsis were more likely to be men and have comorbidities such as cancer, congestive heart failure, diabetes, and renal disease.

Patients with hospital-onset sepsis had longer median lengths of stay (19 days) than the community-onset group (8 days) and the no-sepsis group (4 days). The hospital-onset group also had a greater likelihood of ICU admission (61%) than the community-onset (44%) and no-sepsis (9%) groups.

About 34% of those with hospital-onset sepsis died, compared with 17% of the community-onset group and 2% of the patients who didn’t have sepsis. After adjustment, those with hospital-onset sepsis were still more likely to have died (odds ratio, 2.1; 95% confidence interval, 2.0-2.2).

“Other studies have suggested that there may be delays in the recognition and care of patients who develop sepsis in the hospital as opposed to presenting to the hospital with sepsis,” Dr. Rhee said. “It is also possible that hospital-onset sepsis tends to be caused by organisms that are more virulent and resistant to antibiotics.”

Overall, he said, “our findings underscore the importance of targeting hospital-onset sepsis with surveillance, prevention, and quality improvement efforts.”

The study was funded by the CDC and the Agency for Healthcare Research and Quality. The authors reported no relevant disclosures.

SOURCE: Rhee C et al. CCC48, Abstract 29.

*Correction, 3/19/19: An earlier version of this article misstated the definition of sepsis.

SAN DIEGO – Patients who develop sepsis in the hospital appear to be in greater risk for mortality than those who bring it with them, a new study suggests. Patients with hospital-onset sepsis were twice as likely to die as those infected in the outside world.

MDedge News/Randy Dotinga

“There could be some differences in quality of care that explains the difference in mortality,” said study lead author Chanu Rhee, MD, assistant professor of population medicine at Harvard Medical School, Boston, in a presentation about the findings at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

In an interview, Dr. Rhee said researchers launched the study to gain a greater understanding of the epidemiology of sepsis in the hospital. They relied on a new Centers for Disease Control and Prevention definition of sepsis that is “enhancing the consistency of surveillance across hospitals and allowing more precise differentiation between hospital-onset versus community-onset sepsis.”

The study authors retrospectively tracked more than 2.2 million patients who were treated at 136 U.S. hospitals from 2009 to 2015. In general, hospital-onset sepsis was defined as patients who had a blood culture, initial antibiotic therapy, and organ dysfunction on their third day in the hospital or later.*

Of the patients, 83,600 had community-onset sepsis and 11,500 had hospital-onset sepsis. Those with sepsis were more likely to be men and have comorbidities such as cancer, congestive heart failure, diabetes, and renal disease.

Patients with hospital-onset sepsis had longer median lengths of stay (19 days) than the community-onset group (8 days) and the no-sepsis group (4 days). The hospital-onset group also had a greater likelihood of ICU admission (61%) than the community-onset (44%) and no-sepsis (9%) groups.

About 34% of those with hospital-onset sepsis died, compared with 17% of the community-onset group and 2% of the patients who didn’t have sepsis. After adjustment, those with hospital-onset sepsis were still more likely to have died (odds ratio, 2.1; 95% confidence interval, 2.0-2.2).

“Other studies have suggested that there may be delays in the recognition and care of patients who develop sepsis in the hospital as opposed to presenting to the hospital with sepsis,” Dr. Rhee said. “It is also possible that hospital-onset sepsis tends to be caused by organisms that are more virulent and resistant to antibiotics.”

Overall, he said, “our findings underscore the importance of targeting hospital-onset sepsis with surveillance, prevention, and quality improvement efforts.”

The study was funded by the CDC and the Agency for Healthcare Research and Quality. The authors reported no relevant disclosures.

SOURCE: Rhee C et al. CCC48, Abstract 29.

*Correction, 3/19/19: An earlier version of this article misstated the definition of sepsis.

The FP suspected that this was an acral lentiginous melanoma (ALM).

The FP considered the various ways to biopsy this lesion. Doing a biopsy of the whole lesion was neither practical, nor desirable, given that the lesion was >2 cm and located on the bottom of the patient’s foot. And while incomplete sampling could result in a false negative result, this lesion was so suspicious for melanoma that any well-performed biopsy would likely produce a diagnosis of melanoma. (Of course if melanoma was not diagnosable with partial sampling, a full excisional biopsy would be needed.)

The FP also debated doing a 6-mm punch biopsy vs a shave biopsy; his intent was to get below some of the deeper pigment. Incisional biopsy done as a small ellipse with suturing was also an option. It would also be the most time consuming.

The FP presented the biopsy options to the patient and explained that the shave biopsy would require a dressing and the punch biopsy would require sutures, which would need to be removed at the next visit. Both biopsy methods would likely cause the foot to be uncomfortable to walk on for several days.

The FP and patient decided to do a deep shave biopsy (saucerization). After administering local anesthesia with lidocaine and epinephrine, the FP performed a deep shave biopsy that included about 1 cm of the darkest and thickest portion of the suspected melanoma.

The biopsy results indicated that the patient had an acral lentiginous melanoma, which measured 0.7 mm at its deepest point in the biopsied portion. The patient was referred to Orthopedics for a wide excision and repair. A sentinel node biopsy was not needed because the lesion was less than 1 mm in depth and there was no ulceration. The surgery and healing time were challenging for the patient, but she did not lose her foot and has remained cancer free.

‌

Photo courtesy of Jonathan Karnes, MD and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1103-1111.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP suspected that this was an acral lentiginous melanoma (ALM).

The FP considered the various ways to biopsy this lesion. Doing a biopsy of the whole lesion was neither practical, nor desirable, given that the lesion was >2 cm and located on the bottom of the patient’s foot. And while incomplete sampling could result in a false negative result, this lesion was so suspicious for melanoma that any well-performed biopsy would likely produce a diagnosis of melanoma. (Of course if melanoma was not diagnosable with partial sampling, a full excisional biopsy would be needed.)

The FP also debated doing a 6-mm punch biopsy vs a shave biopsy; his intent was to get below some of the deeper pigment. Incisional biopsy done as a small ellipse with suturing was also an option. It would also be the most time consuming.

The FP presented the biopsy options to the patient and explained that the shave biopsy would require a dressing and the punch biopsy would require sutures, which would need to be removed at the next visit. Both biopsy methods would likely cause the foot to be uncomfortable to walk on for several days.

The FP and patient decided to do a deep shave biopsy (saucerization). After administering local anesthesia with lidocaine and epinephrine, the FP performed a deep shave biopsy that included about 1 cm of the darkest and thickest portion of the suspected melanoma.

The biopsy results indicated that the patient had an acral lentiginous melanoma, which measured 0.7 mm at its deepest point in the biopsied portion. The patient was referred to Orthopedics for a wide excision and repair. A sentinel node biopsy was not needed because the lesion was less than 1 mm in depth and there was no ulceration. The surgery and healing time were challenging for the patient, but she did not lose her foot and has remained cancer free.

‌

Photo courtesy of Jonathan Karnes, MD and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1103-1111.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP suspected that this was an acral lentiginous melanoma (ALM).

The FP considered the various ways to biopsy this lesion. Doing a biopsy of the whole lesion was neither practical, nor desirable, given that the lesion was >2 cm and located on the bottom of the patient’s foot. And while incomplete sampling could result in a false negative result, this lesion was so suspicious for melanoma that any well-performed biopsy would likely produce a diagnosis of melanoma. (Of course if melanoma was not diagnosable with partial sampling, a full excisional biopsy would be needed.)

The FP also debated doing a 6-mm punch biopsy vs a shave biopsy; his intent was to get below some of the deeper pigment. Incisional biopsy done as a small ellipse with suturing was also an option. It would also be the most time consuming.

The FP presented the biopsy options to the patient and explained that the shave biopsy would require a dressing and the punch biopsy would require sutures, which would need to be removed at the next visit. Both biopsy methods would likely cause the foot to be uncomfortable to walk on for several days.

The FP and patient decided to do a deep shave biopsy (saucerization). After administering local anesthesia with lidocaine and epinephrine, the FP performed a deep shave biopsy that included about 1 cm of the darkest and thickest portion of the suspected melanoma.

The biopsy results indicated that the patient had an acral lentiginous melanoma, which measured 0.7 mm at its deepest point in the biopsied portion. The patient was referred to Orthopedics for a wide excision and repair. A sentinel node biopsy was not needed because the lesion was less than 1 mm in depth and there was no ulceration. The surgery and healing time were challenging for the patient, but she did not lose her foot and has remained cancer free.

‌

Photo courtesy of Jonathan Karnes, MD and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1103-1111.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

After last month’s column about the difficulty of firing employees, several readers raised the equally dicey issue of dismissing patients from your practice.

One might assume that, just as patients are free to choose or reject their doctors, physicians have an equal right to reject their patients; and to a certain extent, that’s true. There are no specific laws prohibiting a provider from terminating a patient relationship for any reason, other than a discriminatory one – race, nationality, religion, age, sex, sexual orientation, and so on. However, our ethical obligations to “do no harm” and to place our patients’ welfare above our own self-interests dictate that dismissing a patient should be the absolute last resort, after all other options have been exhausted.

First, to avoid charges of arbitrary termination, you should draw up a specific list of situations that could merit a dismissal from your office, and add it to your office manual. Every list will probably differ in some respects, but for the sake of example, here is mine:

• Threats or violence toward physicians or staff.
• Inappropriate sexual advances toward physicians or staff.
• Providing false or misleading medical history.
• Repeated rude or disruptive behavior.
• Demands for unapproved, unindicated, or inappropriate treatments or medications (particularly controlled substances).
• Refusal to adhere to agreed-upon treatment plans.
• Repeated failure to keep scheduled appointments.
• Repeated failure to pay medical bills.

As with pretty much everything in a private practice, accurate and written documentation of dismissible behavior is essential. Record all incidents and assemble as much material evidence as possible from all available sources.

In most cases (except the first two infractions on our list, for which we have zero tolerance), we make every effort to resolve the problem amicably. We communicate with the patients in question, explain our concerns, and discuss options for resolution. I also may send a letter, repeating my concerns and proposed solutions, as further documentation of our efforts to achieve an amicable resolution. All verbal and written warnings are, of course, documented as well. If the patient has a managed care policy, we review the managed care contract, which sometimes includes specific requirements for dismissal of its patients.

When such efforts fail, we send the patient two letters – one certified with return receipt, the other by conventional first class, in case the patient refuses the certified copy – explaining the reason for dismissal, and that care will be discontinued in 30 days from the letter’s date. (Most attorneys and medical associations agree that 30 days is sufficient reasonable notice.) We offer to provide care during the interim period, include a list of names and contact information for potential alternate providers, and offer to transfer records after receiving written permission.

Following these precautions will usually protect you from charges of “patient abandonment,” which is generally defined as the unilateral severance by the physician of the physician-patient relationship without giving the patient sufficient advance notice to obtain the services of another practitioner, and at a time when the patient still requires medical attention.

Some states have their own unique definitions of patient abandonment. You should check with your state’s health department, and your attorney, for any unusual requirements in your state, because violating these could lead to intervention by your state licensing board. There also is the risk of civil litigation, which typically is not covered by malpractice policies and may not be covered by your general liability policy either.

Patients who feel that termination was unjustified also may respond with negative reviews on social media, which I’ve discussed in recent columns, and will again, soon.

If something untrue is posted about you on a doctor-rating site, take action. Reputable sites have their own reputations to protect and can usually be persuaded to remove anything that is demonstrably false, although you may need a lawyer’s letter to get their attention. Try to get the error removed entirely or corrected within the original posting. An erratum on some distant page of the website is likely to be ignored, and will leave the false information online, intact.

Unfair comments are unlikely to be removed unless they are blatantly libelous; but many sites allow you to post a response, giving your side of the story. (More on that in the near future.) Also, there is nothing wrong with encouraging happy patients to write favorable reviews on those same sites. Sauce for the goose, and all that.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

After last month’s column about the difficulty of firing employees, several readers raised the equally dicey issue of dismissing patients from your practice.

One might assume that, just as patients are free to choose or reject their doctors, physicians have an equal right to reject their patients; and to a certain extent, that’s true. There are no specific laws prohibiting a provider from terminating a patient relationship for any reason, other than a discriminatory one – race, nationality, religion, age, sex, sexual orientation, and so on. However, our ethical obligations to “do no harm” and to place our patients’ welfare above our own self-interests dictate that dismissing a patient should be the absolute last resort, after all other options have been exhausted.

First, to avoid charges of arbitrary termination, you should draw up a specific list of situations that could merit a dismissal from your office, and add it to your office manual. Every list will probably differ in some respects, but for the sake of example, here is mine:

• Threats or violence toward physicians or staff.
• Inappropriate sexual advances toward physicians or staff.
• Providing false or misleading medical history.
• Repeated rude or disruptive behavior.
• Demands for unapproved, unindicated, or inappropriate treatments or medications (particularly controlled substances).
• Refusal to adhere to agreed-upon treatment plans.
• Repeated failure to keep scheduled appointments.
• Repeated failure to pay medical bills.

As with pretty much everything in a private practice, accurate and written documentation of dismissible behavior is essential. Record all incidents and assemble as much material evidence as possible from all available sources.

In most cases (except the first two infractions on our list, for which we have zero tolerance), we make every effort to resolve the problem amicably. We communicate with the patients in question, explain our concerns, and discuss options for resolution. I also may send a letter, repeating my concerns and proposed solutions, as further documentation of our efforts to achieve an amicable resolution. All verbal and written warnings are, of course, documented as well. If the patient has a managed care policy, we review the managed care contract, which sometimes includes specific requirements for dismissal of its patients.

When such efforts fail, we send the patient two letters – one certified with return receipt, the other by conventional first class, in case the patient refuses the certified copy – explaining the reason for dismissal, and that care will be discontinued in 30 days from the letter’s date. (Most attorneys and medical associations agree that 30 days is sufficient reasonable notice.) We offer to provide care during the interim period, include a list of names and contact information for potential alternate providers, and offer to transfer records after receiving written permission.

Following these precautions will usually protect you from charges of “patient abandonment,” which is generally defined as the unilateral severance by the physician of the physician-patient relationship without giving the patient sufficient advance notice to obtain the services of another practitioner, and at a time when the patient still requires medical attention.

Some states have their own unique definitions of patient abandonment. You should check with your state’s health department, and your attorney, for any unusual requirements in your state, because violating these could lead to intervention by your state licensing board. There also is the risk of civil litigation, which typically is not covered by malpractice policies and may not be covered by your general liability policy either.

Patients who feel that termination was unjustified also may respond with negative reviews on social media, which I’ve discussed in recent columns, and will again, soon.

If something untrue is posted about you on a doctor-rating site, take action. Reputable sites have their own reputations to protect and can usually be persuaded to remove anything that is demonstrably false, although you may need a lawyer’s letter to get their attention. Try to get the error removed entirely or corrected within the original posting. An erratum on some distant page of the website is likely to be ignored, and will leave the false information online, intact.

Unfair comments are unlikely to be removed unless they are blatantly libelous; but many sites allow you to post a response, giving your side of the story. (More on that in the near future.) Also, there is nothing wrong with encouraging happy patients to write favorable reviews on those same sites. Sauce for the goose, and all that.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

After last month’s column about the difficulty of firing employees, several readers raised the equally dicey issue of dismissing patients from your practice.

One might assume that, just as patients are free to choose or reject their doctors, physicians have an equal right to reject their patients; and to a certain extent, that’s true. There are no specific laws prohibiting a provider from terminating a patient relationship for any reason, other than a discriminatory one – race, nationality, religion, age, sex, sexual orientation, and so on. However, our ethical obligations to “do no harm” and to place our patients’ welfare above our own self-interests dictate that dismissing a patient should be the absolute last resort, after all other options have been exhausted.

First, to avoid charges of arbitrary termination, you should draw up a specific list of situations that could merit a dismissal from your office, and add it to your office manual. Every list will probably differ in some respects, but for the sake of example, here is mine:

• Threats or violence toward physicians or staff.
• Inappropriate sexual advances toward physicians or staff.
• Providing false or misleading medical history.
• Repeated rude or disruptive behavior.
• Demands for unapproved, unindicated, or inappropriate treatments or medications (particularly controlled substances).
• Refusal to adhere to agreed-upon treatment plans.
• Repeated failure to keep scheduled appointments.
• Repeated failure to pay medical bills.

As with pretty much everything in a private practice, accurate and written documentation of dismissible behavior is essential. Record all incidents and assemble as much material evidence as possible from all available sources.

In most cases (except the first two infractions on our list, for which we have zero tolerance), we make every effort to resolve the problem amicably. We communicate with the patients in question, explain our concerns, and discuss options for resolution. I also may send a letter, repeating my concerns and proposed solutions, as further documentation of our efforts to achieve an amicable resolution. All verbal and written warnings are, of course, documented as well. If the patient has a managed care policy, we review the managed care contract, which sometimes includes specific requirements for dismissal of its patients.

When such efforts fail, we send the patient two letters – one certified with return receipt, the other by conventional first class, in case the patient refuses the certified copy – explaining the reason for dismissal, and that care will be discontinued in 30 days from the letter’s date. (Most attorneys and medical associations agree that 30 days is sufficient reasonable notice.) We offer to provide care during the interim period, include a list of names and contact information for potential alternate providers, and offer to transfer records after receiving written permission.

Following these precautions will usually protect you from charges of “patient abandonment,” which is generally defined as the unilateral severance by the physician of the physician-patient relationship without giving the patient sufficient advance notice to obtain the services of another practitioner, and at a time when the patient still requires medical attention.

Some states have their own unique definitions of patient abandonment. You should check with your state’s health department, and your attorney, for any unusual requirements in your state, because violating these could lead to intervention by your state licensing board. There also is the risk of civil litigation, which typically is not covered by malpractice policies and may not be covered by your general liability policy either.

Patients who feel that termination was unjustified also may respond with negative reviews on social media, which I’ve discussed in recent columns, and will again, soon.

If something untrue is posted about you on a doctor-rating site, take action. Reputable sites have their own reputations to protect and can usually be persuaded to remove anything that is demonstrably false, although you may need a lawyer’s letter to get their attention. Try to get the error removed entirely or corrected within the original posting. An erratum on some distant page of the website is likely to be ignored, and will leave the false information online, intact.

Unfair comments are unlikely to be removed unless they are blatantly libelous; but many sites allow you to post a response, giving your side of the story. (More on that in the near future.) Also, there is nothing wrong with encouraging happy patients to write favorable reviews on those same sites. Sauce for the goose, and all that.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

A combination approach to type 2 diabetes that could improve glycemic control and increase weight loss. Also today, patients with HIV may have a greater risk of opioid overdose, why Eisenmeyer syndrome can be a minefield for unwary physicians, and heart attacks and strokes spike in the month after cancer diagnosis.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

A combination approach to type 2 diabetes that could improve glycemic control and increase weight loss. Also today, patients with HIV may have a greater risk of opioid overdose, why Eisenmeyer syndrome can be a minefield for unwary physicians, and heart attacks and strokes spike in the month after cancer diagnosis.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

A combination approach to type 2 diabetes that could improve glycemic control and increase weight loss. Also today, patients with HIV may have a greater risk of opioid overdose, why Eisenmeyer syndrome can be a minefield for unwary physicians, and heart attacks and strokes spike in the month after cancer diagnosis.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

In this episode, Stefan Barta, MD, of the University of Pennsylvania, joins David Henry, MD, to discuss the treatment and diagnosis of lymphoma in patients with HIV.

And in this week’s Clinical Correlation, Ilana Yurkiewicz, MD, has Part 2 of her discussion on informed consent in cancer. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple Podcasts
Google Podcasts

Show notes
 

By Emily Bryer, DO
Resident in the department of internal medicine, University of Pennsylvania Health System

Immunosuppression in patients with HIV, especially with low CD4 counts, is associated with the development of lymphomas.

Diffuse large B-cell lymphoma is the most common lymphoma in patients with HIV followed by Burkitt lymphoma and Hodgkin lymphoma.

Extra-nodal manifestations of lymphoma are more common in patients with HIV, especially with lower CD4 counts.

Following pathologic diagnosis, staging of lymphoma should include:
- CT scan, PET scan, evaluation of CNS (MRI brain and LP), bone marrow biopsy, and evaluation for hepatitis B and C co-infection.
- Fluorescence in situ hybridization (FISH) is a molecular technique that identifies portions of DNA and helps to identify translocations and rearrangements.
- cMYC, BCL2, and BCL6 are all pro-proliferative genes and commonly implicated in lymphoma.
- cMYC rearrangement poses higher risk of CNS involvement and CNS relapse.
- cMYC rearrangement (as opposed to cMYC translocation) requires therapy that is more aggressive therapy than R-CHOP.


Treatment of high grade diffuse large B-cell lymphoma:
- R-EPOCH
- Ibrutinib plus R-EPOCH

Resources:AIDS Malignancy ConsortiumBlood. 2004;103:275-82.
Blood. 2010 Apr 15; 115(15): 3008–16.
NCT03220022: Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas






 

In this episode, Stefan Barta, MD, of the University of Pennsylvania, joins David Henry, MD, to discuss the treatment and diagnosis of lymphoma in patients with HIV.

And in this week’s Clinical Correlation, Ilana Yurkiewicz, MD, has Part 2 of her discussion on informed consent in cancer. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple Podcasts
Google Podcasts

Show notes
 

By Emily Bryer, DO
Resident in the department of internal medicine, University of Pennsylvania Health System

Immunosuppression in patients with HIV, especially with low CD4 counts, is associated with the development of lymphomas.

Diffuse large B-cell lymphoma is the most common lymphoma in patients with HIV followed by Burkitt lymphoma and Hodgkin lymphoma.

Extra-nodal manifestations of lymphoma are more common in patients with HIV, especially with lower CD4 counts.

Following pathologic diagnosis, staging of lymphoma should include:
- CT scan, PET scan, evaluation of CNS (MRI brain and LP), bone marrow biopsy, and evaluation for hepatitis B and C co-infection.
- Fluorescence in situ hybridization (FISH) is a molecular technique that identifies portions of DNA and helps to identify translocations and rearrangements.
- cMYC, BCL2, and BCL6 are all pro-proliferative genes and commonly implicated in lymphoma.
- cMYC rearrangement poses higher risk of CNS involvement and CNS relapse.
- cMYC rearrangement (as opposed to cMYC translocation) requires therapy that is more aggressive therapy than R-CHOP.


Treatment of high grade diffuse large B-cell lymphoma:
- R-EPOCH
- Ibrutinib plus R-EPOCH

Resources:AIDS Malignancy ConsortiumBlood. 2004;103:275-82.
Blood. 2010 Apr 15; 115(15): 3008–16.
NCT03220022: Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas






 

In this episode, Stefan Barta, MD, of the University of Pennsylvania, joins David Henry, MD, to discuss the treatment and diagnosis of lymphoma in patients with HIV.

And in this week’s Clinical Correlation, Ilana Yurkiewicz, MD, has Part 2 of her discussion on informed consent in cancer. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple Podcasts
Google Podcasts

Show notes
 

By Emily Bryer, DO
Resident in the department of internal medicine, University of Pennsylvania Health System

Immunosuppression in patients with HIV, especially with low CD4 counts, is associated with the development of lymphomas.

Diffuse large B-cell lymphoma is the most common lymphoma in patients with HIV followed by Burkitt lymphoma and Hodgkin lymphoma.

Extra-nodal manifestations of lymphoma are more common in patients with HIV, especially with lower CD4 counts.

Following pathologic diagnosis, staging of lymphoma should include:
- CT scan, PET scan, evaluation of CNS (MRI brain and LP), bone marrow biopsy, and evaluation for hepatitis B and C co-infection.
- Fluorescence in situ hybridization (FISH) is a molecular technique that identifies portions of DNA and helps to identify translocations and rearrangements.
- cMYC, BCL2, and BCL6 are all pro-proliferative genes and commonly implicated in lymphoma.
- cMYC rearrangement poses higher risk of CNS involvement and CNS relapse.
- cMYC rearrangement (as opposed to cMYC translocation) requires therapy that is more aggressive therapy than R-CHOP.


Treatment of high grade diffuse large B-cell lymphoma:
- R-EPOCH
- Ibrutinib plus R-EPOCH

Resources:AIDS Malignancy ConsortiumBlood. 2004;103:275-82.
Blood. 2010 Apr 15; 115(15): 3008–16.
NCT03220022: Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas






 

The primary endpoint – first case of tuberculosis or death from tuberculosis or unknown cause among patients with HIV – was reported in 2% of both arms in the open-label, phase 3, noninferiority trial BRIEF TB (NCT01404312).

iLexx/Thinkstock

In the New England Journal of Medicine (2019 Mar 14;380[11]:1001-11), 3,000 patients with HIV were randomized to receive either 1 month of rifapentine/isoniazid or 9 months of isoniazid monotherapy for prevention of tuberculosis. Although safety was also similar between arms, the completion rate was significantly higher in the combination treatment arm, compared with the monotherapy arm (97% vs. 90%; P less than .001).

We covered this story at the annual Conference on Retroviruses & Opportunistic Infections. See our coverage at the link below.

cpalmer@mdedge.com

The primary endpoint – first case of tuberculosis or death from tuberculosis or unknown cause among patients with HIV – was reported in 2% of both arms in the open-label, phase 3, noninferiority trial BRIEF TB (NCT01404312).

iLexx/Thinkstock

In the New England Journal of Medicine (2019 Mar 14;380[11]:1001-11), 3,000 patients with HIV were randomized to receive either 1 month of rifapentine/isoniazid or 9 months of isoniazid monotherapy for prevention of tuberculosis. Although safety was also similar between arms, the completion rate was significantly higher in the combination treatment arm, compared with the monotherapy arm (97% vs. 90%; P less than .001).

We covered this story at the annual Conference on Retroviruses & Opportunistic Infections. See our coverage at the link below.

cpalmer@mdedge.com

The primary endpoint – first case of tuberculosis or death from tuberculosis or unknown cause among patients with HIV – was reported in 2% of both arms in the open-label, phase 3, noninferiority trial BRIEF TB (NCT01404312).

iLexx/Thinkstock

In the New England Journal of Medicine (2019 Mar 14;380[11]:1001-11), 3,000 patients with HIV were randomized to receive either 1 month of rifapentine/isoniazid or 9 months of isoniazid monotherapy for prevention of tuberculosis. Although safety was also similar between arms, the completion rate was significantly higher in the combination treatment arm, compared with the monotherapy arm (97% vs. 90%; P less than .001).

We covered this story at the annual Conference on Retroviruses & Opportunistic Infections. See our coverage at the link below.

cpalmer@mdedge.com

A novel, oral drug, bempedoic acid, safely cut LDL cholesterol levels by almost 20% in patients who had maxed out their statin treatment, in a pivotal trial with more than 2,000 patients. These findings were the centerpiece of a 4,000-patient-experience labeling application submitted to the Food and Drug Administration in late February 2019 for this first member of the ATP citrate lyase inhibitor class. Based on its performance, bempedoic acid seems on track for agency approval.

Aside from demonstrating safety, the efficacy goal of the CLEAR Harmony (Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk) trial was to cut LDL cholesterol as an add-on to maximally tolerated statin treatment, as well as discretionary use of other lipid-lowering agents in patients with atherosclerotic cardiovascular disease.

That goal appeared to be met by the CLEAR Harmony results, as well as the results from four other studies that contributed data to the approval application filed for bempedoic acid. A clinical outcomes study is underway with more than 12,000 patients aimed at showing incremental clinical benefit from bempedoic acid on top of approved treatments for lowering LDL cholesterol, but those results are not expected until 2022. Until then, the application’s data focus on the evidence that the new drug safely lowers LDL cholesterol when used on top of existing treatments.

“Bempedoic acid provides an additional therapeutic option to safely lower LDL cholesterol in patients with high risk for atherosclerotic cardiovascular disease already treated with a statin,” Kausik K. Ray, MD, said when he first reported these findings during the annual meeting of the European Society of Cardiology last August in Munich. The same results appeared in a newly released article (N Engl J Med. 2019 Mar 14;380[11]:1022-32).

Mitchel L. Zoler/MDedge News

Maximum recommended statin dosages exist because, for every doubling of the statin dosage, LDL cholesterol levels drop by about another 6%, but adverse events grow more common. Because bempedoic acid and other ATP citrate lyase inhibitors work via the same metabolic pathway as that of statins – HMG CoA reductase inhibitors – “we did not know whether squeezing another 20% of LDL cholesterol lowering would be tolerated. What we have clearly and reassuringly shown is it is well tolerated,” said Dr. Ray, a cardiologist and professor of public health at Imperial College, London.

The CLEAR Harmony results showed in 2,230 randomized patients that treatment with bempedoic acid cut LDL cholesterol levels by an average of 18% more compared with placebo in the intention-to-treat analysis, and by 20% in an on-treatment analysis.

By seeking U.S. marketing approval for bempedoic acid based on LDL-lowering and safety only, but without data on clinical endpoints, the company developing the drug is following a path already established by several other lipid-lowering drug classes.

“Statins, ezetimibe and the PCSK9 inhibitors were all approved based on clinical trial results that showed LDL-cholesterol reductions with what the FDA judged to be acceptable safety, but without results from completed outcomes trials,” Christie M. Ballantyne, MD, a coauthor of the CLEAR Harmony study and professor and chief of cardiology at Baylor College of Medicine in Houston, said in an interview.

Stephen Nicholls, MD, professor of cardiology at Monash University in Melbourne, added in an interview that “the precedent has been to conditionally approve LDL cholesterol–lowering drugs at this stage of development, based on the large body of evidence demonstrating that LDL cholesterol–lowering consistently produces clinical benefit.”

Mitchel L. Zoler/MDedge News

This finding “strengthens the likelihood that an outcome trial will show benefits,” Steven E. Nissen, MD, chairman of cardiovascular medicine at the Cleveland Clinic Foundation, and a lead investigator in the bempedoic acid outcomes trial, CLEAR Outcomes, said in an interview.

Dr. Nicholls noted that, on the basis of the genetic study’s results “it would seem very reasonable to extrapolate and expect that bempedoic acid should reduce cardiovascular events.”

The data reported by Dr. Ray and his associates from the CLEAR Harmony trial showed that overall, the adverse-event rates associated with bempedoic acid treatment were similar to the rates seen in patients who received placebo. But Michael V. Holmes, MD, who wrote an editorial that accompanied both reports, highlighted a few differences in the adverse event rates that concerned him. These were a statistically significant higher rate of gout and blood uric acid levels on bempedoic acid treatment compared with controls, a significantly higher rate of discontinuations because of adverse events, and nominally higher rates of death, cardiovascular death, and heart failure hospitalization, said Dr. Holmes, an epidemiologist at the University of Oxford, England.

But Dr. Nissen said that “the safety ‘signals’ involve very small numbers of patients and do not raise major concerns. The increases in gout and uric acid are worth noting, but are less weighty than the disease the drug is intended to treat: major cardiovascular events.”

Dr. Nichols added that “the large cardiovascular outcome trial will provide the opportunity to further study safety and potential side effects. I’m hesitant to overinterpret event data from a relatively small clinical trial that primarily focused on the lipid effects.”

Despite recent success of the PCSK9 inhibitors as an add-on or substitute for statin treatment of elevated LDL cholesterol, the cost of the drugs in this class has made the cardiovascular disease community eager for another alternative to statins.

“The PCSK9 inhibitors are extremely effective, but uptake has been slow due to their cost and formulary restrictions,” said Dr. Ballantyne. “Many high-risk patients continue to have persistently elevated levels of LDL cholesterol.” Bempedoic acid is “a new therapy that can help people who continue to have elevations of LDL cholesterol despite current therapies.”

CLEAR Harmony and the genetic study were sponsored by Esperion, the company developing bempedoic acid. Dr. Ray has been a consultant to several drug companies but had no other financial relationship to Esperion. Dr. Ballantyne and Dr. Nicholls have been consultants to and have received research funding from Esperion and from several other companies. Dr. Nissen is leading an Esperion-sponsored study but has no financial relationships with the company or with other companies.

mzoler@mdedge.com

SOURCEs: N Engl J Med. 2019 Mar 14;380[11]:1022-32 and 1033-42.

A novel, oral drug, bempedoic acid, safely cut LDL cholesterol levels by almost 20% in patients who had maxed out their statin treatment, in a pivotal trial with more than 2,000 patients. These findings were the centerpiece of a 4,000-patient-experience labeling application submitted to the Food and Drug Administration in late February 2019 for this first member of the ATP citrate lyase inhibitor class. Based on its performance, bempedoic acid seems on track for agency approval.

Aside from demonstrating safety, the efficacy goal of the CLEAR Harmony (Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk) trial was to cut LDL cholesterol as an add-on to maximally tolerated statin treatment, as well as discretionary use of other lipid-lowering agents in patients with atherosclerotic cardiovascular disease.

That goal appeared to be met by the CLEAR Harmony results, as well as the results from four other studies that contributed data to the approval application filed for bempedoic acid. A clinical outcomes study is underway with more than 12,000 patients aimed at showing incremental clinical benefit from bempedoic acid on top of approved treatments for lowering LDL cholesterol, but those results are not expected until 2022. Until then, the application’s data focus on the evidence that the new drug safely lowers LDL cholesterol when used on top of existing treatments.

“Bempedoic acid provides an additional therapeutic option to safely lower LDL cholesterol in patients with high risk for atherosclerotic cardiovascular disease already treated with a statin,” Kausik K. Ray, MD, said when he first reported these findings during the annual meeting of the European Society of Cardiology last August in Munich. The same results appeared in a newly released article (N Engl J Med. 2019 Mar 14;380[11]:1022-32).

Mitchel L. Zoler/MDedge News

Maximum recommended statin dosages exist because, for every doubling of the statin dosage, LDL cholesterol levels drop by about another 6%, but adverse events grow more common. Because bempedoic acid and other ATP citrate lyase inhibitors work via the same metabolic pathway as that of statins – HMG CoA reductase inhibitors – “we did not know whether squeezing another 20% of LDL cholesterol lowering would be tolerated. What we have clearly and reassuringly shown is it is well tolerated,” said Dr. Ray, a cardiologist and professor of public health at Imperial College, London.

The CLEAR Harmony results showed in 2,230 randomized patients that treatment with bempedoic acid cut LDL cholesterol levels by an average of 18% more compared with placebo in the intention-to-treat analysis, and by 20% in an on-treatment analysis.

By seeking U.S. marketing approval for bempedoic acid based on LDL-lowering and safety only, but without data on clinical endpoints, the company developing the drug is following a path already established by several other lipid-lowering drug classes.

“Statins, ezetimibe and the PCSK9 inhibitors were all approved based on clinical trial results that showed LDL-cholesterol reductions with what the FDA judged to be acceptable safety, but without results from completed outcomes trials,” Christie M. Ballantyne, MD, a coauthor of the CLEAR Harmony study and professor and chief of cardiology at Baylor College of Medicine in Houston, said in an interview.

Stephen Nicholls, MD, professor of cardiology at Monash University in Melbourne, added in an interview that “the precedent has been to conditionally approve LDL cholesterol–lowering drugs at this stage of development, based on the large body of evidence demonstrating that LDL cholesterol–lowering consistently produces clinical benefit.”

Mitchel L. Zoler/MDedge News

This finding “strengthens the likelihood that an outcome trial will show benefits,” Steven E. Nissen, MD, chairman of cardiovascular medicine at the Cleveland Clinic Foundation, and a lead investigator in the bempedoic acid outcomes trial, CLEAR Outcomes, said in an interview.

Dr. Nicholls noted that, on the basis of the genetic study’s results “it would seem very reasonable to extrapolate and expect that bempedoic acid should reduce cardiovascular events.”

The data reported by Dr. Ray and his associates from the CLEAR Harmony trial showed that overall, the adverse-event rates associated with bempedoic acid treatment were similar to the rates seen in patients who received placebo. But Michael V. Holmes, MD, who wrote an editorial that accompanied both reports, highlighted a few differences in the adverse event rates that concerned him. These were a statistically significant higher rate of gout and blood uric acid levels on bempedoic acid treatment compared with controls, a significantly higher rate of discontinuations because of adverse events, and nominally higher rates of death, cardiovascular death, and heart failure hospitalization, said Dr. Holmes, an epidemiologist at the University of Oxford, England.

But Dr. Nissen said that “the safety ‘signals’ involve very small numbers of patients and do not raise major concerns. The increases in gout and uric acid are worth noting, but are less weighty than the disease the drug is intended to treat: major cardiovascular events.”

Dr. Nichols added that “the large cardiovascular outcome trial will provide the opportunity to further study safety and potential side effects. I’m hesitant to overinterpret event data from a relatively small clinical trial that primarily focused on the lipid effects.”

Despite recent success of the PCSK9 inhibitors as an add-on or substitute for statin treatment of elevated LDL cholesterol, the cost of the drugs in this class has made the cardiovascular disease community eager for another alternative to statins.

“The PCSK9 inhibitors are extremely effective, but uptake has been slow due to their cost and formulary restrictions,” said Dr. Ballantyne. “Many high-risk patients continue to have persistently elevated levels of LDL cholesterol.” Bempedoic acid is “a new therapy that can help people who continue to have elevations of LDL cholesterol despite current therapies.”

CLEAR Harmony and the genetic study were sponsored by Esperion, the company developing bempedoic acid. Dr. Ray has been a consultant to several drug companies but had no other financial relationship to Esperion. Dr. Ballantyne and Dr. Nicholls have been consultants to and have received research funding from Esperion and from several other companies. Dr. Nissen is leading an Esperion-sponsored study but has no financial relationships with the company or with other companies.

mzoler@mdedge.com

SOURCEs: N Engl J Med. 2019 Mar 14;380[11]:1022-32 and 1033-42.

A novel, oral drug, bempedoic acid, safely cut LDL cholesterol levels by almost 20% in patients who had maxed out their statin treatment, in a pivotal trial with more than 2,000 patients. These findings were the centerpiece of a 4,000-patient-experience labeling application submitted to the Food and Drug Administration in late February 2019 for this first member of the ATP citrate lyase inhibitor class. Based on its performance, bempedoic acid seems on track for agency approval.

Aside from demonstrating safety, the efficacy goal of the CLEAR Harmony (Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk) trial was to cut LDL cholesterol as an add-on to maximally tolerated statin treatment, as well as discretionary use of other lipid-lowering agents in patients with atherosclerotic cardiovascular disease.

That goal appeared to be met by the CLEAR Harmony results, as well as the results from four other studies that contributed data to the approval application filed for bempedoic acid. A clinical outcomes study is underway with more than 12,000 patients aimed at showing incremental clinical benefit from bempedoic acid on top of approved treatments for lowering LDL cholesterol, but those results are not expected until 2022. Until then, the application’s data focus on the evidence that the new drug safely lowers LDL cholesterol when used on top of existing treatments.

“Bempedoic acid provides an additional therapeutic option to safely lower LDL cholesterol in patients with high risk for atherosclerotic cardiovascular disease already treated with a statin,” Kausik K. Ray, MD, said when he first reported these findings during the annual meeting of the European Society of Cardiology last August in Munich. The same results appeared in a newly released article (N Engl J Med. 2019 Mar 14;380[11]:1022-32).

Mitchel L. Zoler/MDedge News

Maximum recommended statin dosages exist because, for every doubling of the statin dosage, LDL cholesterol levels drop by about another 6%, but adverse events grow more common. Because bempedoic acid and other ATP citrate lyase inhibitors work via the same metabolic pathway as that of statins – HMG CoA reductase inhibitors – “we did not know whether squeezing another 20% of LDL cholesterol lowering would be tolerated. What we have clearly and reassuringly shown is it is well tolerated,” said Dr. Ray, a cardiologist and professor of public health at Imperial College, London.

The CLEAR Harmony results showed in 2,230 randomized patients that treatment with bempedoic acid cut LDL cholesterol levels by an average of 18% more compared with placebo in the intention-to-treat analysis, and by 20% in an on-treatment analysis.

By seeking U.S. marketing approval for bempedoic acid based on LDL-lowering and safety only, but without data on clinical endpoints, the company developing the drug is following a path already established by several other lipid-lowering drug classes.

“Statins, ezetimibe and the PCSK9 inhibitors were all approved based on clinical trial results that showed LDL-cholesterol reductions with what the FDA judged to be acceptable safety, but without results from completed outcomes trials,” Christie M. Ballantyne, MD, a coauthor of the CLEAR Harmony study and professor and chief of cardiology at Baylor College of Medicine in Houston, said in an interview.

Stephen Nicholls, MD, professor of cardiology at Monash University in Melbourne, added in an interview that “the precedent has been to conditionally approve LDL cholesterol–lowering drugs at this stage of development, based on the large body of evidence demonstrating that LDL cholesterol–lowering consistently produces clinical benefit.”

Mitchel L. Zoler/MDedge News

This finding “strengthens the likelihood that an outcome trial will show benefits,” Steven E. Nissen, MD, chairman of cardiovascular medicine at the Cleveland Clinic Foundation, and a lead investigator in the bempedoic acid outcomes trial, CLEAR Outcomes, said in an interview.

Dr. Nicholls noted that, on the basis of the genetic study’s results “it would seem very reasonable to extrapolate and expect that bempedoic acid should reduce cardiovascular events.”

The data reported by Dr. Ray and his associates from the CLEAR Harmony trial showed that overall, the adverse-event rates associated with bempedoic acid treatment were similar to the rates seen in patients who received placebo. But Michael V. Holmes, MD, who wrote an editorial that accompanied both reports, highlighted a few differences in the adverse event rates that concerned him. These were a statistically significant higher rate of gout and blood uric acid levels on bempedoic acid treatment compared with controls, a significantly higher rate of discontinuations because of adverse events, and nominally higher rates of death, cardiovascular death, and heart failure hospitalization, said Dr. Holmes, an epidemiologist at the University of Oxford, England.

But Dr. Nissen said that “the safety ‘signals’ involve very small numbers of patients and do not raise major concerns. The increases in gout and uric acid are worth noting, but are less weighty than the disease the drug is intended to treat: major cardiovascular events.”

Dr. Nichols added that “the large cardiovascular outcome trial will provide the opportunity to further study safety and potential side effects. I’m hesitant to overinterpret event data from a relatively small clinical trial that primarily focused on the lipid effects.”

Despite recent success of the PCSK9 inhibitors as an add-on or substitute for statin treatment of elevated LDL cholesterol, the cost of the drugs in this class has made the cardiovascular disease community eager for another alternative to statins.

“The PCSK9 inhibitors are extremely effective, but uptake has been slow due to their cost and formulary restrictions,” said Dr. Ballantyne. “Many high-risk patients continue to have persistently elevated levels of LDL cholesterol.” Bempedoic acid is “a new therapy that can help people who continue to have elevations of LDL cholesterol despite current therapies.”

CLEAR Harmony and the genetic study were sponsored by Esperion, the company developing bempedoic acid. Dr. Ray has been a consultant to several drug companies but had no other financial relationship to Esperion. Dr. Ballantyne and Dr. Nicholls have been consultants to and have received research funding from Esperion and from several other companies. Dr. Nissen is leading an Esperion-sponsored study but has no financial relationships with the company or with other companies.

mzoler@mdedge.com

SOURCEs: N Engl J Med. 2019 Mar 14;380[11]:1022-32 and 1033-42.

WASHINGTON – As a result of remarkably sustained antihypertensive effect, interest is intensifying in the potential for a pivotal trial to associate a novel endovascular device with unprecedented blood pressure control in patients with treatment-resistant hypertension, according to an update presented at CRT 2019, sponsored by MedStar Heart & Vascular Institute.

With up to 3 years of follow-up, “systolic blood pressures have remained persistently reduced by as much as 24 mm Hg,” reported John P. Reilly, MD, an interventional cardiologist in Southampton, N.Y., who presented follow-up data for some of those enrolled in the first-in-human study of this device.

When the stent-like device is placed in the carotid artery, it alters its geometric shape, which increases pulsatile wall strain. The increase on wall strain alters an afferent signaling loop controlled by carotid baroreceptors that inhibits sympathetic outflow to lower blood pressure.

In the proof-of-principle, first-in-human CALM study, 47 patients were implanted with the device (MobiusHD, Vascular Dynamics). The initial study enrolled 30 subjects in Europe and 17 in the United States. Initial findings in the cohort of European patients, which included a mean 21–mm Hg reduction in systolic blood pressure and a 12–mm Hg reduction in diastolic blood pressure measured by ambulatory monitoring at 6 months, were published in the Lancet (2017 Dec 16;390[10113]:2655-661).

The patients enrolled in the proof-of-principle CALM trial were required to have highly-treatment-resistant hypertension, defined as a systolic blood pressure greater than or equal to 160 mm Hg despite at least three antihypertensive medications. The average number of medications was 4.4, according to Dr. Reilly. The mean blood pressure at entry was 165/98 mm Hg. Nearly 20% had previously undergone renal denervation.

The device was successfully deployed in all of the patients who participated in the open-label CALM study. Most of the 10 serious adverse events were related to hypotension, according to Dr. Reilly. Others included a wound infection and a case of intermittent claudication. Two instances of neurologic complaints, such as numbness and weakness, experienced within a day of device placement were considered potential transient ischemic attacks, but these resolved completely and no defects were observed on imaging.

In an update on CALM, Dr. Reilly reported that the large reductions in blood pressure previously reported at 6 months have been sustained. Follow-up is approximately 3 years in most patients, and the reductions previously reported have persisted in responders. When a clinically significant response is defined as a 10–mm Hg or more reduction in office blood pressure or 5–mm Hg or more reduction in ambulatory blood pressure, 75% of patients enrolled are still responding, but the more important point is that there has been no substantial reduction in blood pressure control over time in responders, according to Dr. Reilly.

When patients were stratified by a pulse pressure of greater or less than 70 mm Hg at study entry, response rates have been similar, he added.

WASHINGTON – As a result of remarkably sustained antihypertensive effect, interest is intensifying in the potential for a pivotal trial to associate a novel endovascular device with unprecedented blood pressure control in patients with treatment-resistant hypertension, according to an update presented at CRT 2019, sponsored by MedStar Heart & Vascular Institute.

With up to 3 years of follow-up, “systolic blood pressures have remained persistently reduced by as much as 24 mm Hg,” reported John P. Reilly, MD, an interventional cardiologist in Southampton, N.Y., who presented follow-up data for some of those enrolled in the first-in-human study of this device.

When the stent-like device is placed in the carotid artery, it alters its geometric shape, which increases pulsatile wall strain. The increase on wall strain alters an afferent signaling loop controlled by carotid baroreceptors that inhibits sympathetic outflow to lower blood pressure.

In the proof-of-principle, first-in-human CALM study, 47 patients were implanted with the device (MobiusHD, Vascular Dynamics). The initial study enrolled 30 subjects in Europe and 17 in the United States. Initial findings in the cohort of European patients, which included a mean 21–mm Hg reduction in systolic blood pressure and a 12–mm Hg reduction in diastolic blood pressure measured by ambulatory monitoring at 6 months, were published in the Lancet (2017 Dec 16;390[10113]:2655-661).

The patients enrolled in the proof-of-principle CALM trial were required to have highly-treatment-resistant hypertension, defined as a systolic blood pressure greater than or equal to 160 mm Hg despite at least three antihypertensive medications. The average number of medications was 4.4, according to Dr. Reilly. The mean blood pressure at entry was 165/98 mm Hg. Nearly 20% had previously undergone renal denervation.

The device was successfully deployed in all of the patients who participated in the open-label CALM study. Most of the 10 serious adverse events were related to hypotension, according to Dr. Reilly. Others included a wound infection and a case of intermittent claudication. Two instances of neurologic complaints, such as numbness and weakness, experienced within a day of device placement were considered potential transient ischemic attacks, but these resolved completely and no defects were observed on imaging.

In an update on CALM, Dr. Reilly reported that the large reductions in blood pressure previously reported at 6 months have been sustained. Follow-up is approximately 3 years in most patients, and the reductions previously reported have persisted in responders. When a clinically significant response is defined as a 10–mm Hg or more reduction in office blood pressure or 5–mm Hg or more reduction in ambulatory blood pressure, 75% of patients enrolled are still responding, but the more important point is that there has been no substantial reduction in blood pressure control over time in responders, according to Dr. Reilly.

When patients were stratified by a pulse pressure of greater or less than 70 mm Hg at study entry, response rates have been similar, he added.

WASHINGTON – As a result of remarkably sustained antihypertensive effect, interest is intensifying in the potential for a pivotal trial to associate a novel endovascular device with unprecedented blood pressure control in patients with treatment-resistant hypertension, according to an update presented at CRT 2019, sponsored by MedStar Heart & Vascular Institute.

With up to 3 years of follow-up, “systolic blood pressures have remained persistently reduced by as much as 24 mm Hg,” reported John P. Reilly, MD, an interventional cardiologist in Southampton, N.Y., who presented follow-up data for some of those enrolled in the first-in-human study of this device.

When the stent-like device is placed in the carotid artery, it alters its geometric shape, which increases pulsatile wall strain. The increase on wall strain alters an afferent signaling loop controlled by carotid baroreceptors that inhibits sympathetic outflow to lower blood pressure.

In the proof-of-principle, first-in-human CALM study, 47 patients were implanted with the device (MobiusHD, Vascular Dynamics). The initial study enrolled 30 subjects in Europe and 17 in the United States. Initial findings in the cohort of European patients, which included a mean 21–mm Hg reduction in systolic blood pressure and a 12–mm Hg reduction in diastolic blood pressure measured by ambulatory monitoring at 6 months, were published in the Lancet (2017 Dec 16;390[10113]:2655-661).

The patients enrolled in the proof-of-principle CALM trial were required to have highly-treatment-resistant hypertension, defined as a systolic blood pressure greater than or equal to 160 mm Hg despite at least three antihypertensive medications. The average number of medications was 4.4, according to Dr. Reilly. The mean blood pressure at entry was 165/98 mm Hg. Nearly 20% had previously undergone renal denervation.

The device was successfully deployed in all of the patients who participated in the open-label CALM study. Most of the 10 serious adverse events were related to hypotension, according to Dr. Reilly. Others included a wound infection and a case of intermittent claudication. Two instances of neurologic complaints, such as numbness and weakness, experienced within a day of device placement were considered potential transient ischemic attacks, but these resolved completely and no defects were observed on imaging.

In an update on CALM, Dr. Reilly reported that the large reductions in blood pressure previously reported at 6 months have been sustained. Follow-up is approximately 3 years in most patients, and the reductions previously reported have persisted in responders. When a clinically significant response is defined as a 10–mm Hg or more reduction in office blood pressure or 5–mm Hg or more reduction in ambulatory blood pressure, 75% of patients enrolled are still responding, but the more important point is that there has been no substantial reduction in blood pressure control over time in responders, according to Dr. Reilly.

When patients were stratified by a pulse pressure of greater or less than 70 mm Hg at study entry, response rates have been similar, he added.