TORONTO – A thinner-than-normal layer of retinal nerve fibers in the eye is now linked with cognitive decline – another suggestion that extracranial physical findings could be leveraged into dementia screening tools.

The findings were seen in a cohort of 32,000 people enrolled in the U.K. Biobank– an ongoing prospective study following half a million people and collecting data on cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression, and dementia.

The correlation between retinal nerve fiber thickness and cognition was observed in the large cohort at baseline, Fang Sarah Ko, MD, said during a press briefing at the Alzheimer’s Association International Conference 2016. But after following 1,251 of these subjects for 3 years, she and her colleagues found that the correlation continued unabated.

Courtesy National Eye Institute

“It’s amazing that we found this in such a healthy population,” Dr. Ko said during the briefing. “We wouldn’t have expected in just 3 years to see any cognitive decline in this cohort, much less measurable cognitive decline with a significant association with retinal nerve fiber layer thickness.”

Dr. Ko, an ophthalmologist in private practice in Tallahassee, Fla., said later during her main presentation of the study that the finding suggests a possible role for retinal imaging as a cognitive health screen.

“Thinner nerve fiber layer was associated with worse performance on memory, reasoning, and reaction time at baseline, and with a decline in each of these tests over time,” she said. “It may be that the nerve fiber layer could be used as a biomarker,” because it is easy to observe and measure with equipment available in most ophthalmology offices. “I would say the potential for clinical use is quite high.”

The U.K. Biobank recruits all of its subjects through the U.K. National Health Service patient registry. All undergo a standard battery of numerous tests; among them are tests of cognitive function and spectral-domain optical coherence tomography (S-DOCT) of the eye. S-DOCT is an increasingly common method of imaging the retina. It produces three-dimensional images of extremely fine resolution.

The 32,000 subjects included in the baseline cohort were all free of diabetes and ocular or neurological disease, and they had normal intraocular pressure. They undertook four tests of cognition: prospective memory, pairs matching, numeric and verbal reasoning, and reaction time. The relationship between these test results and retinal nerve fiber thickness was adjusted for age, sex, race, socioeconomic status, height, refraction, and intraocular pressure.

At baseline, the mean retinal nerve fiber layer was significantly thinner among subjects with abnormal scores on any of the cognitive tests. On the prospective memory test, the layer was an average of 53.3 micrometers for subjects who had correct first-time recall, 52.5 micrometers for those with correct second-time recall, and 51.9 micrometers for those who did not recall. The layer was also significantly thinner in subjects who had low scores on pairs matching, numeric and verbal reasoning, and reaction times.

And the relationship between test results and retinal nerve fiber thinning appeared additive, Dr. Ko said. For each test that a subject failed, the layer was about 1 micrometer thinner. In the multivariate analysis, thinner retinal nerve fiber layer was associated with worse performance on all of the tests: The layer was 0.13 micrometer thinner for each incorrect match on pairs matching; 0.14 micrometer thinner for every 2 points lower in score on numeric and verbal reasoning; and 0.14 micrometer thinner for every 100 millisecond slower reaction time.

The 3-year follow-up data confirmed that these baseline findings persisted, and predicted cognitive decline. “Again, this was true after controlling for all the variables,” Dr. Ko said. “We found that those with the thinnest layers at baseline got worse on more of the tests, compared to those who had the thickest nerve fiber layers at baseline.”

Although this is the first time retinal nerve fiber thickness has predicted cognitive decline, the association with cognition has been studied for a few years. A 2015 meta-analysis found 17 studies comparing the marker between patients with Alzheimer’s and healthy controls and 5 studies of patients with mild cognitive impairment MCI) and healthy controls (Alzheimers Dement (Amst). 2015 Apr 23;1[2]:136-43). All of these found significant retinal nerve fiber thinning in Alzheimer’s and MCI patients.

The lead author of that paper, Kelsey Thompson of the University of Edinburgh (United Kingdom), said the retinal ganglion cell axons can be seen as a sentinel marker for neurodegeneration in the brain.

“Retinal nerve fiber layer thinning in [Alzheimer’s disease] has been hypothesized to occur because of retrograde degeneration of the retinal ganglion cell axons, and these changes have been suggested to occur even before memory is affected. There is also a suggestion that neuroretinal atrophy may occur as a result of amyloid-beta plaque deposits within the retina, although this hypothesis remains more speculative.”

Dr. Ko had no financial declarations.

[email protected]

On Twitter @alz_gal

TORONTO – A thinner-than-normal layer of retinal nerve fibers in the eye is now linked with cognitive decline – another suggestion that extracranial physical findings could be leveraged into dementia screening tools.

The findings were seen in a cohort of 32,000 people enrolled in the U.K. Biobank– an ongoing prospective study following half a million people and collecting data on cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression, and dementia.

The correlation between retinal nerve fiber thickness and cognition was observed in the large cohort at baseline, Fang Sarah Ko, MD, said during a press briefing at the Alzheimer’s Association International Conference 2016. But after following 1,251 of these subjects for 3 years, she and her colleagues found that the correlation continued unabated.

Courtesy National Eye Institute

“It’s amazing that we found this in such a healthy population,” Dr. Ko said during the briefing. “We wouldn’t have expected in just 3 years to see any cognitive decline in this cohort, much less measurable cognitive decline with a significant association with retinal nerve fiber layer thickness.”

Dr. Ko, an ophthalmologist in private practice in Tallahassee, Fla., said later during her main presentation of the study that the finding suggests a possible role for retinal imaging as a cognitive health screen.

“Thinner nerve fiber layer was associated with worse performance on memory, reasoning, and reaction time at baseline, and with a decline in each of these tests over time,” she said. “It may be that the nerve fiber layer could be used as a biomarker,” because it is easy to observe and measure with equipment available in most ophthalmology offices. “I would say the potential for clinical use is quite high.”

The U.K. Biobank recruits all of its subjects through the U.K. National Health Service patient registry. All undergo a standard battery of numerous tests; among them are tests of cognitive function and spectral-domain optical coherence tomography (S-DOCT) of the eye. S-DOCT is an increasingly common method of imaging the retina. It produces three-dimensional images of extremely fine resolution.

The 32,000 subjects included in the baseline cohort were all free of diabetes and ocular or neurological disease, and they had normal intraocular pressure. They undertook four tests of cognition: prospective memory, pairs matching, numeric and verbal reasoning, and reaction time. The relationship between these test results and retinal nerve fiber thickness was adjusted for age, sex, race, socioeconomic status, height, refraction, and intraocular pressure.

At baseline, the mean retinal nerve fiber layer was significantly thinner among subjects with abnormal scores on any of the cognitive tests. On the prospective memory test, the layer was an average of 53.3 micrometers for subjects who had correct first-time recall, 52.5 micrometers for those with correct second-time recall, and 51.9 micrometers for those who did not recall. The layer was also significantly thinner in subjects who had low scores on pairs matching, numeric and verbal reasoning, and reaction times.

And the relationship between test results and retinal nerve fiber thinning appeared additive, Dr. Ko said. For each test that a subject failed, the layer was about 1 micrometer thinner. In the multivariate analysis, thinner retinal nerve fiber layer was associated with worse performance on all of the tests: The layer was 0.13 micrometer thinner for each incorrect match on pairs matching; 0.14 micrometer thinner for every 2 points lower in score on numeric and verbal reasoning; and 0.14 micrometer thinner for every 100 millisecond slower reaction time.

The 3-year follow-up data confirmed that these baseline findings persisted, and predicted cognitive decline. “Again, this was true after controlling for all the variables,” Dr. Ko said. “We found that those with the thinnest layers at baseline got worse on more of the tests, compared to those who had the thickest nerve fiber layers at baseline.”

Although this is the first time retinal nerve fiber thickness has predicted cognitive decline, the association with cognition has been studied for a few years. A 2015 meta-analysis found 17 studies comparing the marker between patients with Alzheimer’s and healthy controls and 5 studies of patients with mild cognitive impairment MCI) and healthy controls (Alzheimers Dement (Amst). 2015 Apr 23;1[2]:136-43). All of these found significant retinal nerve fiber thinning in Alzheimer’s and MCI patients.

The lead author of that paper, Kelsey Thompson of the University of Edinburgh (United Kingdom), said the retinal ganglion cell axons can be seen as a sentinel marker for neurodegeneration in the brain.

“Retinal nerve fiber layer thinning in [Alzheimer’s disease] has been hypothesized to occur because of retrograde degeneration of the retinal ganglion cell axons, and these changes have been suggested to occur even before memory is affected. There is also a suggestion that neuroretinal atrophy may occur as a result of amyloid-beta plaque deposits within the retina, although this hypothesis remains more speculative.”

Dr. Ko had no financial declarations.

[email protected]

On Twitter @alz_gal

TORONTO – A thinner-than-normal layer of retinal nerve fibers in the eye is now linked with cognitive decline – another suggestion that extracranial physical findings could be leveraged into dementia screening tools.

The findings were seen in a cohort of 32,000 people enrolled in the U.K. Biobank– an ongoing prospective study following half a million people and collecting data on cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression, and dementia.

The correlation between retinal nerve fiber thickness and cognition was observed in the large cohort at baseline, Fang Sarah Ko, MD, said during a press briefing at the Alzheimer’s Association International Conference 2016. But after following 1,251 of these subjects for 3 years, she and her colleagues found that the correlation continued unabated.

Courtesy National Eye Institute

“It’s amazing that we found this in such a healthy population,” Dr. Ko said during the briefing. “We wouldn’t have expected in just 3 years to see any cognitive decline in this cohort, much less measurable cognitive decline with a significant association with retinal nerve fiber layer thickness.”

Dr. Ko, an ophthalmologist in private practice in Tallahassee, Fla., said later during her main presentation of the study that the finding suggests a possible role for retinal imaging as a cognitive health screen.

“Thinner nerve fiber layer was associated with worse performance on memory, reasoning, and reaction time at baseline, and with a decline in each of these tests over time,” she said. “It may be that the nerve fiber layer could be used as a biomarker,” because it is easy to observe and measure with equipment available in most ophthalmology offices. “I would say the potential for clinical use is quite high.”

The U.K. Biobank recruits all of its subjects through the U.K. National Health Service patient registry. All undergo a standard battery of numerous tests; among them are tests of cognitive function and spectral-domain optical coherence tomography (S-DOCT) of the eye. S-DOCT is an increasingly common method of imaging the retina. It produces three-dimensional images of extremely fine resolution.

The 32,000 subjects included in the baseline cohort were all free of diabetes and ocular or neurological disease, and they had normal intraocular pressure. They undertook four tests of cognition: prospective memory, pairs matching, numeric and verbal reasoning, and reaction time. The relationship between these test results and retinal nerve fiber thickness was adjusted for age, sex, race, socioeconomic status, height, refraction, and intraocular pressure.

At baseline, the mean retinal nerve fiber layer was significantly thinner among subjects with abnormal scores on any of the cognitive tests. On the prospective memory test, the layer was an average of 53.3 micrometers for subjects who had correct first-time recall, 52.5 micrometers for those with correct second-time recall, and 51.9 micrometers for those who did not recall. The layer was also significantly thinner in subjects who had low scores on pairs matching, numeric and verbal reasoning, and reaction times.

And the relationship between test results and retinal nerve fiber thinning appeared additive, Dr. Ko said. For each test that a subject failed, the layer was about 1 micrometer thinner. In the multivariate analysis, thinner retinal nerve fiber layer was associated with worse performance on all of the tests: The layer was 0.13 micrometer thinner for each incorrect match on pairs matching; 0.14 micrometer thinner for every 2 points lower in score on numeric and verbal reasoning; and 0.14 micrometer thinner for every 100 millisecond slower reaction time.

The 3-year follow-up data confirmed that these baseline findings persisted, and predicted cognitive decline. “Again, this was true after controlling for all the variables,” Dr. Ko said. “We found that those with the thinnest layers at baseline got worse on more of the tests, compared to those who had the thickest nerve fiber layers at baseline.”

Although this is the first time retinal nerve fiber thickness has predicted cognitive decline, the association with cognition has been studied for a few years. A 2015 meta-analysis found 17 studies comparing the marker between patients with Alzheimer’s and healthy controls and 5 studies of patients with mild cognitive impairment MCI) and healthy controls (Alzheimers Dement (Amst). 2015 Apr 23;1[2]:136-43). All of these found significant retinal nerve fiber thinning in Alzheimer’s and MCI patients.

The lead author of that paper, Kelsey Thompson of the University of Edinburgh (United Kingdom), said the retinal ganglion cell axons can be seen as a sentinel marker for neurodegeneration in the brain.

“Retinal nerve fiber layer thinning in [Alzheimer’s disease] has been hypothesized to occur because of retrograde degeneration of the retinal ganglion cell axons, and these changes have been suggested to occur even before memory is affected. There is also a suggestion that neuroretinal atrophy may occur as a result of amyloid-beta plaque deposits within the retina, although this hypothesis remains more speculative.”

Dr. Ko had no financial declarations.

[email protected]

On Twitter @alz_gal

DURBAN, SOUTH AFRICA – Same-day HIV testing and initiation of antiretroviral therapy results in significantly better outcomes at 12 months than does the common practice of delaying ART for days to weeks in order to provide counseling and conduct further tests, Serena Koenig, MD, reported at the 21st International AIDS Conference.

“With standard testing protocols, patients are given the terrible news that they are HIV-positive and then discharged home without treatment. We believe that if we roll out the red carpet on that very challenging first day and provide extra attention and same-day ART, we increase a sense of hope, optimism, and connectedness to health care providers,” explained Dr. Koenig of Brigham and Women’s Hospital, Boston.

Bruce Jancin/Frontline Medical News

She presented a randomized, prospective clinical trial involving 577 patients at the GHESKIO Clinic in Port-au-Prince, Haiti, the world’s oldest HIV/AIDS treatment clinic and the largest provider of HIV/AIDS care in the Caribbean. Participants, all of whom had a positive HIV test, were randomized to same-day initiation of ART or to standard care, which was discharge home with instructions to return once per week for three counseling and clinical evaluation visits, with ART to begin on day 21.

Both groups received identical services and the same number of contacts with physicians and social workers in the first month following their HIV diagnosis. The only difference was the timing of ART initiation.

Study eligibility was restricted to patients with World Health Organization stage 1 or 2 HIV disease and a same-day chest x-ray showing no indication of tuberculosis or pneumonia.

The primary study endpoint was the rate of retention in care with a plasma HIV RNA viral load of less than 50 copies/mL at 12 months follow-up. This target was achieved in 54% of the same-day ART group, compared with 42% of controls.

Same-day ART also proved significantly better than the standard protocol in terms of the secondary study endpoints. It was associated with 3% mortality at 12 months, compared with 7% in the control arm. Also, 61% of patients in the same-day ART group were retained in care with a viral load of less than 1,000 copies/mL at 12 months, compared with 50% of controls.

In a multivariate regression analysis adjusted for patient demographics and clinical factors, same-day ART was independently associated with a 76% greater likelihood of retention in care with a viral load below 50 copies/mL at 12 months, a 65% reduction in the risk of mortality, and a 67% greater likelihood of retention in care with a viral load of less than 1,000 copies/mL.

The usual rationale for scheduling multiple pre-ART clinic visits is that patients may need time to come to grips with the reality that they require lifelong treatment, coupled with a feeling among many clinicians that there is no real urgency regarding ART initiation. But Dr. Koenig characterized the standard practice of requiring several clinic visits before starting ART as “a missed opportunity.”

“Delays in treatment are associated with increased mortality, diminished recovery of CD4+ cells, higher cost of treatment for opportunistic infections, and ongoing HIV transmission,” she said. “In addition to making things logistically easy, a big part of our study of same-day ART was the foundation of hope.”

Dr. Koenig reported having no financial conflicts with regard to this study, which was funded by the National Institute of Allergy and Infectious Diseases.

[email protected]

DURBAN, SOUTH AFRICA – Same-day HIV testing and initiation of antiretroviral therapy results in significantly better outcomes at 12 months than does the common practice of delaying ART for days to weeks in order to provide counseling and conduct further tests, Serena Koenig, MD, reported at the 21st International AIDS Conference.

“With standard testing protocols, patients are given the terrible news that they are HIV-positive and then discharged home without treatment. We believe that if we roll out the red carpet on that very challenging first day and provide extra attention and same-day ART, we increase a sense of hope, optimism, and connectedness to health care providers,” explained Dr. Koenig of Brigham and Women’s Hospital, Boston.

Bruce Jancin/Frontline Medical News

She presented a randomized, prospective clinical trial involving 577 patients at the GHESKIO Clinic in Port-au-Prince, Haiti, the world’s oldest HIV/AIDS treatment clinic and the largest provider of HIV/AIDS care in the Caribbean. Participants, all of whom had a positive HIV test, were randomized to same-day initiation of ART or to standard care, which was discharge home with instructions to return once per week for three counseling and clinical evaluation visits, with ART to begin on day 21.

Both groups received identical services and the same number of contacts with physicians and social workers in the first month following their HIV diagnosis. The only difference was the timing of ART initiation.

Study eligibility was restricted to patients with World Health Organization stage 1 or 2 HIV disease and a same-day chest x-ray showing no indication of tuberculosis or pneumonia.

The primary study endpoint was the rate of retention in care with a plasma HIV RNA viral load of less than 50 copies/mL at 12 months follow-up. This target was achieved in 54% of the same-day ART group, compared with 42% of controls.

Same-day ART also proved significantly better than the standard protocol in terms of the secondary study endpoints. It was associated with 3% mortality at 12 months, compared with 7% in the control arm. Also, 61% of patients in the same-day ART group were retained in care with a viral load of less than 1,000 copies/mL at 12 months, compared with 50% of controls.

In a multivariate regression analysis adjusted for patient demographics and clinical factors, same-day ART was independently associated with a 76% greater likelihood of retention in care with a viral load below 50 copies/mL at 12 months, a 65% reduction in the risk of mortality, and a 67% greater likelihood of retention in care with a viral load of less than 1,000 copies/mL.

The usual rationale for scheduling multiple pre-ART clinic visits is that patients may need time to come to grips with the reality that they require lifelong treatment, coupled with a feeling among many clinicians that there is no real urgency regarding ART initiation. But Dr. Koenig characterized the standard practice of requiring several clinic visits before starting ART as “a missed opportunity.”

“Delays in treatment are associated with increased mortality, diminished recovery of CD4+ cells, higher cost of treatment for opportunistic infections, and ongoing HIV transmission,” she said. “In addition to making things logistically easy, a big part of our study of same-day ART was the foundation of hope.”

Dr. Koenig reported having no financial conflicts with regard to this study, which was funded by the National Institute of Allergy and Infectious Diseases.

[email protected]

DURBAN, SOUTH AFRICA – Same-day HIV testing and initiation of antiretroviral therapy results in significantly better outcomes at 12 months than does the common practice of delaying ART for days to weeks in order to provide counseling and conduct further tests, Serena Koenig, MD, reported at the 21st International AIDS Conference.

“With standard testing protocols, patients are given the terrible news that they are HIV-positive and then discharged home without treatment. We believe that if we roll out the red carpet on that very challenging first day and provide extra attention and same-day ART, we increase a sense of hope, optimism, and connectedness to health care providers,” explained Dr. Koenig of Brigham and Women’s Hospital, Boston.

Bruce Jancin/Frontline Medical News

She presented a randomized, prospective clinical trial involving 577 patients at the GHESKIO Clinic in Port-au-Prince, Haiti, the world’s oldest HIV/AIDS treatment clinic and the largest provider of HIV/AIDS care in the Caribbean. Participants, all of whom had a positive HIV test, were randomized to same-day initiation of ART or to standard care, which was discharge home with instructions to return once per week for three counseling and clinical evaluation visits, with ART to begin on day 21.

Both groups received identical services and the same number of contacts with physicians and social workers in the first month following their HIV diagnosis. The only difference was the timing of ART initiation.

Study eligibility was restricted to patients with World Health Organization stage 1 or 2 HIV disease and a same-day chest x-ray showing no indication of tuberculosis or pneumonia.

The primary study endpoint was the rate of retention in care with a plasma HIV RNA viral load of less than 50 copies/mL at 12 months follow-up. This target was achieved in 54% of the same-day ART group, compared with 42% of controls.

Same-day ART also proved significantly better than the standard protocol in terms of the secondary study endpoints. It was associated with 3% mortality at 12 months, compared with 7% in the control arm. Also, 61% of patients in the same-day ART group were retained in care with a viral load of less than 1,000 copies/mL at 12 months, compared with 50% of controls.

In a multivariate regression analysis adjusted for patient demographics and clinical factors, same-day ART was independently associated with a 76% greater likelihood of retention in care with a viral load below 50 copies/mL at 12 months, a 65% reduction in the risk of mortality, and a 67% greater likelihood of retention in care with a viral load of less than 1,000 copies/mL.

The usual rationale for scheduling multiple pre-ART clinic visits is that patients may need time to come to grips with the reality that they require lifelong treatment, coupled with a feeling among many clinicians that there is no real urgency regarding ART initiation. But Dr. Koenig characterized the standard practice of requiring several clinic visits before starting ART as “a missed opportunity.”

“Delays in treatment are associated with increased mortality, diminished recovery of CD4+ cells, higher cost of treatment for opportunistic infections, and ongoing HIV transmission,” she said. “In addition to making things logistically easy, a big part of our study of same-day ART was the foundation of hope.”

Dr. Koenig reported having no financial conflicts with regard to this study, which was funded by the National Institute of Allergy and Infectious Diseases.

[email protected]

As state governments struggle to find a balance between access to hepatitis C drugs and being able to afford them, it appears that individual deals with drug manufacturers will be the way to get these drugs to a wider portion of the population.

Most recently, MassHealth, Massachusetts’ state Medicaid agency, negotiated with Gilead Sciences on new rebates that the agency said will “significantly” lower the cost on the hepatitis C drug Harvoni.

©s-c-s/Thinkstock

“I think it probably is the direction we are going in hepatitis C coverage,” Matt Salo, executive director of the National Association of Medicaid Directors (NAMD), said in an interivew. “Pricing has been a real challenge nationwide, certainly for Medicaid itself. Medicaid’s got an obligation to … like state budgets, balance a budget every single year. When we’ve got massive cost spikes in any one particular area, it generally tends to come with trade-offs you have to make elsewhere that aren’t necessarily in the best interest of everybody involved.”

According to the deal, Harvoni will be the exclusive drug used to treat hepatitis C for about 80% of patients in need. MassHealth also negotiated rebates for Gilead’s Sovaldi and Bristol-Myers Squibb’s Daklinza, which are indicated for about 20% of hepatitis C patients. The state expects to be able to cover most people in the state with hepatitis C.

Given the cost of hepatitis C drugs, which can reach into the $90,000 range for a course of treatment, state Medicaid agencies were putting access restrictions on the drug. However, as lawsuits were limiting states’ abilities to apply utilization management, negotiations with the drug companies became another avenue.

“When those lawsuits hit and were decided, most recently in Washington state and Delaware, it basically said and basically confirmed that Medicaid has to cover everybody,” Mr. Salo said. “That put the pricing issue right back in the forefront, because states like Massachusetts, Florida, and New York are going down this road of trying to figure out if we are going to open up coverage to everybody. How do we manage this?”

He noted that competition has helped make the price more manageable, but challenges still remain because of the cost of these drugs and prices still need to come down.

“Now that you’ve got three manufacturers – Gilead, AbbVie, and Merck – there is a little bit more of a competitive market at play,” Mr. Salo noted. “When the Merck product came on, they intentionally priced it lower than the other stuff in the market, which is good. These are all good things, but I still think the challenge we are going to face now is it’s still not gotten down to a price that’s low enough to really make it affordable to cover a million people in the Medicaid program.”

However, Mr. Salo said he does not see prices themselves coming down much further, unless perhaps a new competitor can come in and shake the market up further. As such, NAMD is looking toward legislative solutions to address the hepatitis C drug market.

He narrowed it down to three areas: price, cost, and access control.

Mr. Salo was quick to note that Congress doing something about price would look very much like price controls and would probably be a tough sell politically.

However, the federal government could help in other ways, such as creating a fund similar to the one the government uses to help pay for HIV/AIDS drugs.

“These are a bunch of things that wouldn’t touch on the manufacturers’ profit margin but might be things like an increased federal match for the drugs or perhaps creating a separate standalone federal program to provide hepatitis C treatments for patients much in the same way that Congress created the Ryan White program when it was clear that the cost of HIV/AIDS treatments were too much for the market to bear,” he said.

He also suggested that perhaps Medicare could help pay for the Medicaid coverage of hepatitis C drugs.

“If you think about cost savings to the system, the savings will be reaped by Medicare because it won’t be until those folks are 65 and older that the liver fibrosis and other types of things will really start to take effect,” he said. “Is there a way to bring Medicare in to offset some of the cost?”

Finally, he suggested Congress give state Medicaid agencies explicit authority to apply utilization management to help prioritize patients in need of these treatments.

[email protected]

As state governments struggle to find a balance between access to hepatitis C drugs and being able to afford them, it appears that individual deals with drug manufacturers will be the way to get these drugs to a wider portion of the population.

Most recently, MassHealth, Massachusetts’ state Medicaid agency, negotiated with Gilead Sciences on new rebates that the agency said will “significantly” lower the cost on the hepatitis C drug Harvoni.

©s-c-s/Thinkstock

“I think it probably is the direction we are going in hepatitis C coverage,” Matt Salo, executive director of the National Association of Medicaid Directors (NAMD), said in an interivew. “Pricing has been a real challenge nationwide, certainly for Medicaid itself. Medicaid’s got an obligation to … like state budgets, balance a budget every single year. When we’ve got massive cost spikes in any one particular area, it generally tends to come with trade-offs you have to make elsewhere that aren’t necessarily in the best interest of everybody involved.”

According to the deal, Harvoni will be the exclusive drug used to treat hepatitis C for about 80% of patients in need. MassHealth also negotiated rebates for Gilead’s Sovaldi and Bristol-Myers Squibb’s Daklinza, which are indicated for about 20% of hepatitis C patients. The state expects to be able to cover most people in the state with hepatitis C.

Given the cost of hepatitis C drugs, which can reach into the $90,000 range for a course of treatment, state Medicaid agencies were putting access restrictions on the drug. However, as lawsuits were limiting states’ abilities to apply utilization management, negotiations with the drug companies became another avenue.

“When those lawsuits hit and were decided, most recently in Washington state and Delaware, it basically said and basically confirmed that Medicaid has to cover everybody,” Mr. Salo said. “That put the pricing issue right back in the forefront, because states like Massachusetts, Florida, and New York are going down this road of trying to figure out if we are going to open up coverage to everybody. How do we manage this?”

He noted that competition has helped make the price more manageable, but challenges still remain because of the cost of these drugs and prices still need to come down.

“Now that you’ve got three manufacturers – Gilead, AbbVie, and Merck – there is a little bit more of a competitive market at play,” Mr. Salo noted. “When the Merck product came on, they intentionally priced it lower than the other stuff in the market, which is good. These are all good things, but I still think the challenge we are going to face now is it’s still not gotten down to a price that’s low enough to really make it affordable to cover a million people in the Medicaid program.”

However, Mr. Salo said he does not see prices themselves coming down much further, unless perhaps a new competitor can come in and shake the market up further. As such, NAMD is looking toward legislative solutions to address the hepatitis C drug market.

He narrowed it down to three areas: price, cost, and access control.

Mr. Salo was quick to note that Congress doing something about price would look very much like price controls and would probably be a tough sell politically.

However, the federal government could help in other ways, such as creating a fund similar to the one the government uses to help pay for HIV/AIDS drugs.

“These are a bunch of things that wouldn’t touch on the manufacturers’ profit margin but might be things like an increased federal match for the drugs or perhaps creating a separate standalone federal program to provide hepatitis C treatments for patients much in the same way that Congress created the Ryan White program when it was clear that the cost of HIV/AIDS treatments were too much for the market to bear,” he said.

He also suggested that perhaps Medicare could help pay for the Medicaid coverage of hepatitis C drugs.

“If you think about cost savings to the system, the savings will be reaped by Medicare because it won’t be until those folks are 65 and older that the liver fibrosis and other types of things will really start to take effect,” he said. “Is there a way to bring Medicare in to offset some of the cost?”

Finally, he suggested Congress give state Medicaid agencies explicit authority to apply utilization management to help prioritize patients in need of these treatments.

[email protected]

As state governments struggle to find a balance between access to hepatitis C drugs and being able to afford them, it appears that individual deals with drug manufacturers will be the way to get these drugs to a wider portion of the population.

Most recently, MassHealth, Massachusetts’ state Medicaid agency, negotiated with Gilead Sciences on new rebates that the agency said will “significantly” lower the cost on the hepatitis C drug Harvoni.

©s-c-s/Thinkstock

“I think it probably is the direction we are going in hepatitis C coverage,” Matt Salo, executive director of the National Association of Medicaid Directors (NAMD), said in an interivew. “Pricing has been a real challenge nationwide, certainly for Medicaid itself. Medicaid’s got an obligation to … like state budgets, balance a budget every single year. When we’ve got massive cost spikes in any one particular area, it generally tends to come with trade-offs you have to make elsewhere that aren’t necessarily in the best interest of everybody involved.”

According to the deal, Harvoni will be the exclusive drug used to treat hepatitis C for about 80% of patients in need. MassHealth also negotiated rebates for Gilead’s Sovaldi and Bristol-Myers Squibb’s Daklinza, which are indicated for about 20% of hepatitis C patients. The state expects to be able to cover most people in the state with hepatitis C.

Given the cost of hepatitis C drugs, which can reach into the $90,000 range for a course of treatment, state Medicaid agencies were putting access restrictions on the drug. However, as lawsuits were limiting states’ abilities to apply utilization management, negotiations with the drug companies became another avenue.

“When those lawsuits hit and were decided, most recently in Washington state and Delaware, it basically said and basically confirmed that Medicaid has to cover everybody,” Mr. Salo said. “That put the pricing issue right back in the forefront, because states like Massachusetts, Florida, and New York are going down this road of trying to figure out if we are going to open up coverage to everybody. How do we manage this?”

He noted that competition has helped make the price more manageable, but challenges still remain because of the cost of these drugs and prices still need to come down.

“Now that you’ve got three manufacturers – Gilead, AbbVie, and Merck – there is a little bit more of a competitive market at play,” Mr. Salo noted. “When the Merck product came on, they intentionally priced it lower than the other stuff in the market, which is good. These are all good things, but I still think the challenge we are going to face now is it’s still not gotten down to a price that’s low enough to really make it affordable to cover a million people in the Medicaid program.”

However, Mr. Salo said he does not see prices themselves coming down much further, unless perhaps a new competitor can come in and shake the market up further. As such, NAMD is looking toward legislative solutions to address the hepatitis C drug market.

He narrowed it down to three areas: price, cost, and access control.

Mr. Salo was quick to note that Congress doing something about price would look very much like price controls and would probably be a tough sell politically.

However, the federal government could help in other ways, such as creating a fund similar to the one the government uses to help pay for HIV/AIDS drugs.

“These are a bunch of things that wouldn’t touch on the manufacturers’ profit margin but might be things like an increased federal match for the drugs or perhaps creating a separate standalone federal program to provide hepatitis C treatments for patients much in the same way that Congress created the Ryan White program when it was clear that the cost of HIV/AIDS treatments were too much for the market to bear,” he said.

He also suggested that perhaps Medicare could help pay for the Medicaid coverage of hepatitis C drugs.

“If you think about cost savings to the system, the savings will be reaped by Medicare because it won’t be until those folks are 65 and older that the liver fibrosis and other types of things will really start to take effect,” he said. “Is there a way to bring Medicare in to offset some of the cost?”

Finally, he suggested Congress give state Medicaid agencies explicit authority to apply utilization management to help prioritize patients in need of these treatments.

[email protected]

BOSTON – Malignancy in a chronic leg wound can be very aggressive, and multidisciplinary care is a must – particularly in those who oppose amputation, according to Tania J. Phillips, MD.

“When you get a more advanced, malignant, ulcerated wound, this is really a complex situation that requires multidisciplinary care,” she said at the American Academy of Dermatology summer meeting.

In addition to dermatologic care, patients may need medical oncology, surgery, radiation, and good nursing care, she explained.

For patients with malignancy who oppose amputation, a palliative care team may also be a necessity, said Dr. Phillips, professor of dermatology at Boston University. She described one patient she cared for who had an ulcerated wound with squamous cell carcinoma. The patient was treated daily 5 days per week for 2 months. The wound did not heal.

“In these kinds of patients you may not heal the wound; you may just have to try to keep the wound clean, free of pain, and free of infection, she said.

COMFORT is a valuable mnemonic device for caring for such patients, she said: Care for pain and itching, use Odor control, Manage exudate and bleeding, Fight infection, Optimize peri-wound skin integrity, use Reparative and aesthetic wound dressings, Treat the cancer.

Pain is a major issue in patients with such wounds. It is important assess the wound etiology and treat the underlying disease, but it is also important to assess the pain and try to manage it, Dr. Phillips said. Often, addressing local wound management will help with the pain. Appropriate dressing selection is particularly important, as dressing changes can be very painful, she said, recommending the use of non-stick dressings that keep the wound moist. Local and systemic treatment may also be necessary to control pain and itching, she said.

Odor control is another concern. Necrotic tissue has a lot of odor, so debridement can help.

“Use a 19-guage needle to cleanse the wound,” she suggested, noting that this provides higher pressure that can be effective for cleansing.

Dressings that contain nanocrystalline silver or activated charcoal can also help.

As for managing exudate and bleeding, dressing choice is again an important consideration. More absorbent dressings like alginates are useful and have hemostatic properties that can also help with bleeding. Frequent dressing changes are also important.

“And obviously, you want to treat infection,” Dr. Phillips added. Metronidazole gel or powder can help with both infection and odor, she noted.

Peri-wound skin can be very fragile, so it is important to provide protection. In some cases, this can be addressed simply with zinc oxide or petrolatum. Various skin sealants are also available, and can be used to form a barrier to dressings that can be damaging to the skin.

Silicone dressings are very powerful because they don’t stick to the skin, and are not painful or damaging when removed, she said.

The use of a window with hydrocolloid dressing, which allows for changing only the inside of the dressing, is another useful approach, and using mesh rather than tape to hold the dressing in place can help to protect peri-wound skin.

Dr. Phillips reported a financial relationship with Hygeia.

[email protected]

BOSTON – Malignancy in a chronic leg wound can be very aggressive, and multidisciplinary care is a must – particularly in those who oppose amputation, according to Tania J. Phillips, MD.

“When you get a more advanced, malignant, ulcerated wound, this is really a complex situation that requires multidisciplinary care,” she said at the American Academy of Dermatology summer meeting.

In addition to dermatologic care, patients may need medical oncology, surgery, radiation, and good nursing care, she explained.

For patients with malignancy who oppose amputation, a palliative care team may also be a necessity, said Dr. Phillips, professor of dermatology at Boston University. She described one patient she cared for who had an ulcerated wound with squamous cell carcinoma. The patient was treated daily 5 days per week for 2 months. The wound did not heal.

“In these kinds of patients you may not heal the wound; you may just have to try to keep the wound clean, free of pain, and free of infection, she said.

COMFORT is a valuable mnemonic device for caring for such patients, she said: Care for pain and itching, use Odor control, Manage exudate and bleeding, Fight infection, Optimize peri-wound skin integrity, use Reparative and aesthetic wound dressings, Treat the cancer.

Pain is a major issue in patients with such wounds. It is important assess the wound etiology and treat the underlying disease, but it is also important to assess the pain and try to manage it, Dr. Phillips said. Often, addressing local wound management will help with the pain. Appropriate dressing selection is particularly important, as dressing changes can be very painful, she said, recommending the use of non-stick dressings that keep the wound moist. Local and systemic treatment may also be necessary to control pain and itching, she said.

Odor control is another concern. Necrotic tissue has a lot of odor, so debridement can help.

“Use a 19-guage needle to cleanse the wound,” she suggested, noting that this provides higher pressure that can be effective for cleansing.

Dressings that contain nanocrystalline silver or activated charcoal can also help.

As for managing exudate and bleeding, dressing choice is again an important consideration. More absorbent dressings like alginates are useful and have hemostatic properties that can also help with bleeding. Frequent dressing changes are also important.

“And obviously, you want to treat infection,” Dr. Phillips added. Metronidazole gel or powder can help with both infection and odor, she noted.

Peri-wound skin can be very fragile, so it is important to provide protection. In some cases, this can be addressed simply with zinc oxide or petrolatum. Various skin sealants are also available, and can be used to form a barrier to dressings that can be damaging to the skin.

Silicone dressings are very powerful because they don’t stick to the skin, and are not painful or damaging when removed, she said.

The use of a window with hydrocolloid dressing, which allows for changing only the inside of the dressing, is another useful approach, and using mesh rather than tape to hold the dressing in place can help to protect peri-wound skin.

Dr. Phillips reported a financial relationship with Hygeia.

[email protected]

BOSTON – Malignancy in a chronic leg wound can be very aggressive, and multidisciplinary care is a must – particularly in those who oppose amputation, according to Tania J. Phillips, MD.

“When you get a more advanced, malignant, ulcerated wound, this is really a complex situation that requires multidisciplinary care,” she said at the American Academy of Dermatology summer meeting.

In addition to dermatologic care, patients may need medical oncology, surgery, radiation, and good nursing care, she explained.

For patients with malignancy who oppose amputation, a palliative care team may also be a necessity, said Dr. Phillips, professor of dermatology at Boston University. She described one patient she cared for who had an ulcerated wound with squamous cell carcinoma. The patient was treated daily 5 days per week for 2 months. The wound did not heal.

“In these kinds of patients you may not heal the wound; you may just have to try to keep the wound clean, free of pain, and free of infection, she said.

COMFORT is a valuable mnemonic device for caring for such patients, she said: Care for pain and itching, use Odor control, Manage exudate and bleeding, Fight infection, Optimize peri-wound skin integrity, use Reparative and aesthetic wound dressings, Treat the cancer.

Pain is a major issue in patients with such wounds. It is important assess the wound etiology and treat the underlying disease, but it is also important to assess the pain and try to manage it, Dr. Phillips said. Often, addressing local wound management will help with the pain. Appropriate dressing selection is particularly important, as dressing changes can be very painful, she said, recommending the use of non-stick dressings that keep the wound moist. Local and systemic treatment may also be necessary to control pain and itching, she said.

Odor control is another concern. Necrotic tissue has a lot of odor, so debridement can help.

“Use a 19-guage needle to cleanse the wound,” she suggested, noting that this provides higher pressure that can be effective for cleansing.

Dressings that contain nanocrystalline silver or activated charcoal can also help.

As for managing exudate and bleeding, dressing choice is again an important consideration. More absorbent dressings like alginates are useful and have hemostatic properties that can also help with bleeding. Frequent dressing changes are also important.

“And obviously, you want to treat infection,” Dr. Phillips added. Metronidazole gel or powder can help with both infection and odor, she noted.

Peri-wound skin can be very fragile, so it is important to provide protection. In some cases, this can be addressed simply with zinc oxide or petrolatum. Various skin sealants are also available, and can be used to form a barrier to dressings that can be damaging to the skin.

Silicone dressings are very powerful because they don’t stick to the skin, and are not painful or damaging when removed, she said.

The use of a window with hydrocolloid dressing, which allows for changing only the inside of the dressing, is another useful approach, and using mesh rather than tape to hold the dressing in place can help to protect peri-wound skin.

Dr. Phillips reported a financial relationship with Hygeia.

[email protected]

TORONTO – For patients with Alzheimer’s disease, early treatment may translate into lower health care costs and better survival, based on study results reported at the Alzheimer’s Association International Conference 2016.

A review of Medicare claims data from more than 1,300 patients who received a diagnosis of Alzheimer’s disease during 2010-2013 found that patients who got standard anti-dementia therapy within a month of an Alzheimer’s diagnosis had a 28% lower risk of dying by 6 months than did patients who weren’t treated. And while their health care costs spiked at the time of diagnosis, monthly costs were consistently lower, yielding an overall savings of about $1,700 by the end of the study.

©Kheng guan Toh/Thinkstock

It’s not that the drugs themselves exerted any lifesaving effects, said study co-author Christopher Black, associate director of outcomes research at Merck Research Laboratories, Rahway, N.J. Rather, the observed benefit is probably because the patients who got treated also then got consistent medical attention for health-threatening comorbidities.

“This is an important caveat,” Mr. Black said in an interview at the meeting. “We are not saying that anti-dementia treatment is causing longer survival. It’s a proxy for better care. Typically, dementia patients die of complications from comorbidities that are exacerbated by Alzheimer’s symptoms.”

Mr. Black and his colleagues examined healthcare costs and utilization during the 12 months before diagnosis and in the 6 months after diagnosis. They also looked at mortality incidence. He and his colleagues identified 6,553 incident Alzheimer’s patients. Just 35% received a prescription for an anti-dementia medication within the month after diagnosis. Most patients (67%) got donepezil. Other prescribed medications were memantine (19%), rivastigmine (12%) and galantamine (2%).

There were several significant differences between the treated and untreated groups. Untreated patients were older (84 vs. 81 years) and had a significantly higher Charlson comorbidity index (3.5 vs. 3.2). To account for these differences, the researchers used propensity score matching on the basis of medical comorbidities, age, and other demographics to compare 694 patients from each group.

At the end of 6 months, treated patients had a 28% lower risk of dying (hazard ratio, 0.72) than did non-treated patients. Health care costs and utilization showed significant differences as well. Before diagnosis, monthly medical costs were similar (average $665). During the month of diagnosis, costs surged for both groups, although more so in the group that was untreated (mean $6,711 vs. $5,535). This probably reflected the general health differences between the two groups, as well as the cost of transitioning into a hospital, or from a hospital to a long-term care facility, Mr. Black said.

“This spike at the time of diagnosis is important,” he said in an interview. “The major cost driver was inpatient hospitalization and skilled nursing home placement, and this was driven by 10% of the patients.”

After the first month, costs declined and stabilized in each group. However, the between-group differences remained. There were half as many hospice visits per month among the treated patients (0.04 vs. 0.09; P = .0001). Monthly costs overall were lower, but not to a statistically significant extent ($2,207 vs. $2,349; P = .3037). Total health care costs by the end of the follow-up period averaged about $1,700 less in treated patients.

“Even after adjusting for demographic and clinical differences, results suggested that treated Alzheimer’s patients had lower all-cause health care costs and lower mortality rates compared to untreated patients,” Mr. Black said. “The arguments for early treatment are myriad, but this study shows greater survival and less all-cause health care costs among those receiving treatment for dementia. These results indicate that choosing not to treat, or even a delay in starting treatment, may lead to less favorable results. Early diagnosis and time to treatment should be a priority for policymakers, physicians and the public.”

TORONTO – For patients with Alzheimer’s disease, early treatment may translate into lower health care costs and better survival, based on study results reported at the Alzheimer’s Association International Conference 2016.

A review of Medicare claims data from more than 1,300 patients who received a diagnosis of Alzheimer’s disease during 2010-2013 found that patients who got standard anti-dementia therapy within a month of an Alzheimer’s diagnosis had a 28% lower risk of dying by 6 months than did patients who weren’t treated. And while their health care costs spiked at the time of diagnosis, monthly costs were consistently lower, yielding an overall savings of about $1,700 by the end of the study.

©Kheng guan Toh/Thinkstock

It’s not that the drugs themselves exerted any lifesaving effects, said study co-author Christopher Black, associate director of outcomes research at Merck Research Laboratories, Rahway, N.J. Rather, the observed benefit is probably because the patients who got treated also then got consistent medical attention for health-threatening comorbidities.

“This is an important caveat,” Mr. Black said in an interview at the meeting. “We are not saying that anti-dementia treatment is causing longer survival. It’s a proxy for better care. Typically, dementia patients die of complications from comorbidities that are exacerbated by Alzheimer’s symptoms.”

Mr. Black and his colleagues examined healthcare costs and utilization during the 12 months before diagnosis and in the 6 months after diagnosis. They also looked at mortality incidence. He and his colleagues identified 6,553 incident Alzheimer’s patients. Just 35% received a prescription for an anti-dementia medication within the month after diagnosis. Most patients (67%) got donepezil. Other prescribed medications were memantine (19%), rivastigmine (12%) and galantamine (2%).

There were several significant differences between the treated and untreated groups. Untreated patients were older (84 vs. 81 years) and had a significantly higher Charlson comorbidity index (3.5 vs. 3.2). To account for these differences, the researchers used propensity score matching on the basis of medical comorbidities, age, and other demographics to compare 694 patients from each group.

At the end of 6 months, treated patients had a 28% lower risk of dying (hazard ratio, 0.72) than did non-treated patients. Health care costs and utilization showed significant differences as well. Before diagnosis, monthly medical costs were similar (average $665). During the month of diagnosis, costs surged for both groups, although more so in the group that was untreated (mean $6,711 vs. $5,535). This probably reflected the general health differences between the two groups, as well as the cost of transitioning into a hospital, or from a hospital to a long-term care facility, Mr. Black said.

“This spike at the time of diagnosis is important,” he said in an interview. “The major cost driver was inpatient hospitalization and skilled nursing home placement, and this was driven by 10% of the patients.”

After the first month, costs declined and stabilized in each group. However, the between-group differences remained. There were half as many hospice visits per month among the treated patients (0.04 vs. 0.09; P = .0001). Monthly costs overall were lower, but not to a statistically significant extent ($2,207 vs. $2,349; P = .3037). Total health care costs by the end of the follow-up period averaged about $1,700 less in treated patients.

“Even after adjusting for demographic and clinical differences, results suggested that treated Alzheimer’s patients had lower all-cause health care costs and lower mortality rates compared to untreated patients,” Mr. Black said. “The arguments for early treatment are myriad, but this study shows greater survival and less all-cause health care costs among those receiving treatment for dementia. These results indicate that choosing not to treat, or even a delay in starting treatment, may lead to less favorable results. Early diagnosis and time to treatment should be a priority for policymakers, physicians and the public.”

TORONTO – For patients with Alzheimer’s disease, early treatment may translate into lower health care costs and better survival, based on study results reported at the Alzheimer’s Association International Conference 2016.

A review of Medicare claims data from more than 1,300 patients who received a diagnosis of Alzheimer’s disease during 2010-2013 found that patients who got standard anti-dementia therapy within a month of an Alzheimer’s diagnosis had a 28% lower risk of dying by 6 months than did patients who weren’t treated. And while their health care costs spiked at the time of diagnosis, monthly costs were consistently lower, yielding an overall savings of about $1,700 by the end of the study.

©Kheng guan Toh/Thinkstock

It’s not that the drugs themselves exerted any lifesaving effects, said study co-author Christopher Black, associate director of outcomes research at Merck Research Laboratories, Rahway, N.J. Rather, the observed benefit is probably because the patients who got treated also then got consistent medical attention for health-threatening comorbidities.

“This is an important caveat,” Mr. Black said in an interview at the meeting. “We are not saying that anti-dementia treatment is causing longer survival. It’s a proxy for better care. Typically, dementia patients die of complications from comorbidities that are exacerbated by Alzheimer’s symptoms.”

Mr. Black and his colleagues examined healthcare costs and utilization during the 12 months before diagnosis and in the 6 months after diagnosis. They also looked at mortality incidence. He and his colleagues identified 6,553 incident Alzheimer’s patients. Just 35% received a prescription for an anti-dementia medication within the month after diagnosis. Most patients (67%) got donepezil. Other prescribed medications were memantine (19%), rivastigmine (12%) and galantamine (2%).

There were several significant differences between the treated and untreated groups. Untreated patients were older (84 vs. 81 years) and had a significantly higher Charlson comorbidity index (3.5 vs. 3.2). To account for these differences, the researchers used propensity score matching on the basis of medical comorbidities, age, and other demographics to compare 694 patients from each group.

At the end of 6 months, treated patients had a 28% lower risk of dying (hazard ratio, 0.72) than did non-treated patients. Health care costs and utilization showed significant differences as well. Before diagnosis, monthly medical costs were similar (average $665). During the month of diagnosis, costs surged for both groups, although more so in the group that was untreated (mean $6,711 vs. $5,535). This probably reflected the general health differences between the two groups, as well as the cost of transitioning into a hospital, or from a hospital to a long-term care facility, Mr. Black said.

“This spike at the time of diagnosis is important,” he said in an interview. “The major cost driver was inpatient hospitalization and skilled nursing home placement, and this was driven by 10% of the patients.”

After the first month, costs declined and stabilized in each group. However, the between-group differences remained. There were half as many hospice visits per month among the treated patients (0.04 vs. 0.09; P = .0001). Monthly costs overall were lower, but not to a statistically significant extent ($2,207 vs. $2,349; P = .3037). Total health care costs by the end of the follow-up period averaged about $1,700 less in treated patients.

“Even after adjusting for demographic and clinical differences, results suggested that treated Alzheimer’s patients had lower all-cause health care costs and lower mortality rates compared to untreated patients,” Mr. Black said. “The arguments for early treatment are myriad, but this study shows greater survival and less all-cause health care costs among those receiving treatment for dementia. These results indicate that choosing not to treat, or even a delay in starting treatment, may lead to less favorable results. Early diagnosis and time to treatment should be a priority for policymakers, physicians and the public.”

TORONTO – For patients with Alzheimer’s disease, early treatment may translate into lower health care costs and better survival, based on study results reported at the Alzheimer’s Association International Conference 2016.

A review of Medicare claims data from more than 1,300 patients who received a diagnosis of Alzheimer’s disease during 2010-2013 found that patients who got standard anti-dementia therapy within a month of an Alzheimer’s diagnosis had a 28% lower risk of dying by 6 months than did patients who weren’t treated. And while their health care costs spiked at the time of diagnosis, monthly costs were consistently lower, yielding an overall savings of about $1,700 by the end of the study.

©Kheng guan Toh/Thinkstock

It’s not that the drugs themselves exerted any lifesaving effects, said study co-author Christopher Black, associate director of outcomes research at Merck Research Laboratories, Rahway, N.J. Rather, the observed benefit is probably because the patients who got treated also then got consistent medical attention for health-threatening comorbidities.

“This is an important caveat,” Mr. Black said in an interview at the meeting. “We are not saying that anti-dementia treatment is causing longer survival. It’s a proxy for better care. Typically, dementia patients die of complications from comorbidities that are exacerbated by Alzheimer’s symptoms.”

Mr. Black and his colleagues examined healthcare costs and utilization during the 12 months before diagnosis and in the 6 months after diagnosis. They also looked at mortality incidence. He and his colleagues identified 6,553 incident Alzheimer’s patients. Just 35% received a prescription for an anti-dementia medication within the month after diagnosis. Most patients (67%) got donepezil. Other prescribed medications were memantine (19%), rivastigmine (12%) and galantamine (2%).

There were several significant differences between the treated and untreated groups. Untreated patients were older (84 vs. 81 years) and had a significantly higher Charlson comorbidity index (3.5 vs. 3.2). To account for these differences, the researchers used propensity score matching on the basis of medical comorbidities, age, and other demographics to compare 694 patients from each group.

At the end of 6 months, treated patients had a 28% lower risk of dying (hazard ratio, 0.72) than did non-treated patients. Health care costs and utilization showed significant differences as well. Before diagnosis, monthly medical costs were similar (average $665). During the month of diagnosis, costs surged for both groups, although more so in the group that was untreated (mean $6,711 vs. $5,535). This probably reflected the general health differences between the two groups, as well as the cost of transitioning into a hospital, or from a hospital to a long-term care facility, Mr. Black said.

“This spike at the time of diagnosis is important,” he said in an interview. “The major cost driver was inpatient hospitalization and skilled nursing home placement, and this was driven by 10% of the patients.”

After the first month, costs declined and stabilized in each group. However, the between-group differences remained. There were half as many hospice visits per month among the treated patients (0.04 vs. 0.09; P = .0001). Monthly costs overall were lower, but not to a statistically significant extent ($2,207 vs. $2,349; P = .3037). Total health care costs by the end of the follow-up period averaged about $1,700 less in treated patients.

“Even after adjusting for demographic and clinical differences, results suggested that treated Alzheimer’s patients had lower all-cause health care costs and lower mortality rates compared to untreated patients,” Mr. Black said. “The arguments for early treatment are myriad, but this study shows greater survival and less all-cause health care costs among those receiving treatment for dementia. These results indicate that choosing not to treat, or even a delay in starting treatment, may lead to less favorable results. Early diagnosis and time to treatment should be a priority for policymakers, physicians and the public.”

[email protected]

On Twitter @alz_gal

TORONTO – For patients with Alzheimer’s disease, early treatment may translate into lower health care costs and better survival, based on study results reported at the Alzheimer’s Association International Conference 2016.

A review of Medicare claims data from more than 1,300 patients who received a diagnosis of Alzheimer’s disease during 2010-2013 found that patients who got standard anti-dementia therapy within a month of an Alzheimer’s diagnosis had a 28% lower risk of dying by 6 months than did patients who weren’t treated. And while their health care costs spiked at the time of diagnosis, monthly costs were consistently lower, yielding an overall savings of about $1,700 by the end of the study.

©Kheng guan Toh/Thinkstock

It’s not that the drugs themselves exerted any lifesaving effects, said study co-author Christopher Black, associate director of outcomes research at Merck Research Laboratories, Rahway, N.J. Rather, the observed benefit is probably because the patients who got treated also then got consistent medical attention for health-threatening comorbidities.

“This is an important caveat,” Mr. Black said in an interview at the meeting. “We are not saying that anti-dementia treatment is causing longer survival. It’s a proxy for better care. Typically, dementia patients die of complications from comorbidities that are exacerbated by Alzheimer’s symptoms.”

Mr. Black and his colleagues examined healthcare costs and utilization during the 12 months before diagnosis and in the 6 months after diagnosis. They also looked at mortality incidence. He and his colleagues identified 6,553 incident Alzheimer’s patients. Just 35% received a prescription for an anti-dementia medication within the month after diagnosis. Most patients (67%) got donepezil. Other prescribed medications were memantine (19%), rivastigmine (12%) and galantamine (2%).

There were several significant differences between the treated and untreated groups. Untreated patients were older (84 vs. 81 years) and had a significantly higher Charlson comorbidity index (3.5 vs. 3.2). To account for these differences, the researchers used propensity score matching on the basis of medical comorbidities, age, and other demographics to compare 694 patients from each group.

At the end of 6 months, treated patients had a 28% lower risk of dying (hazard ratio, 0.72) than did non-treated patients. Health care costs and utilization showed significant differences as well. Before diagnosis, monthly medical costs were similar (average $665). During the month of diagnosis, costs surged for both groups, although more so in the group that was untreated (mean $6,711 vs. $5,535). This probably reflected the general health differences between the two groups, as well as the cost of transitioning into a hospital, or from a hospital to a long-term care facility, Mr. Black said.

“This spike at the time of diagnosis is important,” he said in an interview. “The major cost driver was inpatient hospitalization and skilled nursing home placement, and this was driven by 10% of the patients.”

After the first month, costs declined and stabilized in each group. However, the between-group differences remained. There were half as many hospice visits per month among the treated patients (0.04 vs. 0.09; P = .0001). Monthly costs overall were lower, but not to a statistically significant extent ($2,207 vs. $2,349; P = .3037). Total health care costs by the end of the follow-up period averaged about $1,700 less in treated patients.

“Even after adjusting for demographic and clinical differences, results suggested that treated Alzheimer’s patients had lower all-cause health care costs and lower mortality rates compared to untreated patients,” Mr. Black said. “The arguments for early treatment are myriad, but this study shows greater survival and less all-cause health care costs among those receiving treatment for dementia. These results indicate that choosing not to treat, or even a delay in starting treatment, may lead to less favorable results. Early diagnosis and time to treatment should be a priority for policymakers, physicians and the public.”

[email protected]

On Twitter @alz_gal

TORONTO – For patients with Alzheimer’s disease, early treatment may translate into lower health care costs and better survival, based on study results reported at the Alzheimer’s Association International Conference 2016.

A review of Medicare claims data from more than 1,300 patients who received a diagnosis of Alzheimer’s disease during 2010-2013 found that patients who got standard anti-dementia therapy within a month of an Alzheimer’s diagnosis had a 28% lower risk of dying by 6 months than did patients who weren’t treated. And while their health care costs spiked at the time of diagnosis, monthly costs were consistently lower, yielding an overall savings of about $1,700 by the end of the study.

©Kheng guan Toh/Thinkstock

It’s not that the drugs themselves exerted any lifesaving effects, said study co-author Christopher Black, associate director of outcomes research at Merck Research Laboratories, Rahway, N.J. Rather, the observed benefit is probably because the patients who got treated also then got consistent medical attention for health-threatening comorbidities.

“This is an important caveat,” Mr. Black said in an interview at the meeting. “We are not saying that anti-dementia treatment is causing longer survival. It’s a proxy for better care. Typically, dementia patients die of complications from comorbidities that are exacerbated by Alzheimer’s symptoms.”

Mr. Black and his colleagues examined healthcare costs and utilization during the 12 months before diagnosis and in the 6 months after diagnosis. They also looked at mortality incidence. He and his colleagues identified 6,553 incident Alzheimer’s patients. Just 35% received a prescription for an anti-dementia medication within the month after diagnosis. Most patients (67%) got donepezil. Other prescribed medications were memantine (19%), rivastigmine (12%) and galantamine (2%).

There were several significant differences between the treated and untreated groups. Untreated patients were older (84 vs. 81 years) and had a significantly higher Charlson comorbidity index (3.5 vs. 3.2). To account for these differences, the researchers used propensity score matching on the basis of medical comorbidities, age, and other demographics to compare 694 patients from each group.

At the end of 6 months, treated patients had a 28% lower risk of dying (hazard ratio, 0.72) than did non-treated patients. Health care costs and utilization showed significant differences as well. Before diagnosis, monthly medical costs were similar (average $665). During the month of diagnosis, costs surged for both groups, although more so in the group that was untreated (mean $6,711 vs. $5,535). This probably reflected the general health differences between the two groups, as well as the cost of transitioning into a hospital, or from a hospital to a long-term care facility, Mr. Black said.

“This spike at the time of diagnosis is important,” he said in an interview. “The major cost driver was inpatient hospitalization and skilled nursing home placement, and this was driven by 10% of the patients.”

After the first month, costs declined and stabilized in each group. However, the between-group differences remained. There were half as many hospice visits per month among the treated patients (0.04 vs. 0.09; P = .0001). Monthly costs overall were lower, but not to a statistically significant extent ($2,207 vs. $2,349; P = .3037). Total health care costs by the end of the follow-up period averaged about $1,700 less in treated patients.

“Even after adjusting for demographic and clinical differences, results suggested that treated Alzheimer’s patients had lower all-cause health care costs and lower mortality rates compared to untreated patients,” Mr. Black said. “The arguments for early treatment are myriad, but this study shows greater survival and less all-cause health care costs among those receiving treatment for dementia. These results indicate that choosing not to treat, or even a delay in starting treatment, may lead to less favorable results. Early diagnosis and time to treatment should be a priority for policymakers, physicians and the public.”

[email protected]

On Twitter @alz_gal

One of the most frustrating problems we encounter is helping patients with skin issues that we cannot immediately fix or cure. Teaching them the art of concealing skin blemishes gives patients a sense of relief. Color correction is an art and requires an understanding of basic color theory and Fitzpatrick skin type.

On the color wheel, each color sits directly across from another color, making them complementary colors.

Thoth_Adan (thinkstockimages)

If we look at red, the color opposing it is green. When red and green are combined, they neutralize each other. One of the greatest dermatologists of all time and my mentor, Timothy Berger, MD, taught me that in dermatology color “hue” is a clue to understanding morphology. Everything that is red cannot just be called “erythematous.” There is orange/red (pityriasis rosea, tinea versicolor, seborrheic dermatitis), deep red (cellulitis, Sweet’s syndrome, acne scars, rosacea, psoriasis), purple/red (vasculitis, lichen planus (LP), veins, under-eye circles), brown/red (pigmented purpura, pigmented acne scars, sarcoid).

The combination of the underlying pathology, morphology, and Fitzpatrick type is both a clue to diagnosis and a pallet for skin concealers. We can use the following techniques to help patients color correct skin imperfections:

Red: rosacea, acne scars, acne

Green-based concealers and primers are the best option to significantly reduce the redness. While green primers and correctors tend to be great for Fitzpatrick skin types I-III, a yellow-based concealer/corrector can help to cover redness on those with skin types IV-VI.

Blue: periorbital veins

If you are dealing with blue-toned skin lesions, such as periorbital veins, the ideal corrector is one with a peach or orange undertones. For skin types I-III, a peach/salmon corrector works best, whereas skin types IV-VI requires an orange-toned corrector.

Purple: under-eye circles, LP, postprocedure bruising

If under-eye circles tend to have a more purple hue to them, a yellow-based corrector works best for skin types I-III. For skin types IV-VI skin types, you will need a corrector with a red undertone.

Yellow: bruising

Purple/lavender correctors are best suited for eliminating yellow tones from the face. Purple also combats sallow undertones of the skin.

Brown: lentigines, melasma, seborrheic keratosis, post-inflammatory hyperpigmentation, nevi, café au lait spots

Brown is actually the hardest of all colors to correct. The deeper the pigment (ashy dermatitis, melasma) the more gray the areas appear with skin concealers. The more superficial the pigment (ephelides, lentigines), the easier it is to correct. Generally speaking, peach toned concealers work best, not beige or brown. The corrector, however, should be lighter than the skin tone or the lesion itself will appear darker.

Helping patients conceal imperfections with these simple guidelines is a great way to help relieve some anxiety and help our patients fell more confident in their skin.

Dr. Talakoub and Dr. Wesley are co-contributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected].

One of the most frustrating problems we encounter is helping patients with skin issues that we cannot immediately fix or cure. Teaching them the art of concealing skin blemishes gives patients a sense of relief. Color correction is an art and requires an understanding of basic color theory and Fitzpatrick skin type.

On the color wheel, each color sits directly across from another color, making them complementary colors.

Thoth_Adan (thinkstockimages)

If we look at red, the color opposing it is green. When red and green are combined, they neutralize each other. One of the greatest dermatologists of all time and my mentor, Timothy Berger, MD, taught me that in dermatology color “hue” is a clue to understanding morphology. Everything that is red cannot just be called “erythematous.” There is orange/red (pityriasis rosea, tinea versicolor, seborrheic dermatitis), deep red (cellulitis, Sweet’s syndrome, acne scars, rosacea, psoriasis), purple/red (vasculitis, lichen planus (LP), veins, under-eye circles), brown/red (pigmented purpura, pigmented acne scars, sarcoid).

The combination of the underlying pathology, morphology, and Fitzpatrick type is both a clue to diagnosis and a pallet for skin concealers. We can use the following techniques to help patients color correct skin imperfections:

Red: rosacea, acne scars, acne

Green-based concealers and primers are the best option to significantly reduce the redness. While green primers and correctors tend to be great for Fitzpatrick skin types I-III, a yellow-based concealer/corrector can help to cover redness on those with skin types IV-VI.

Blue: periorbital veins

If you are dealing with blue-toned skin lesions, such as periorbital veins, the ideal corrector is one with a peach or orange undertones. For skin types I-III, a peach/salmon corrector works best, whereas skin types IV-VI requires an orange-toned corrector.

Purple: under-eye circles, LP, postprocedure bruising

If under-eye circles tend to have a more purple hue to them, a yellow-based corrector works best for skin types I-III. For skin types IV-VI skin types, you will need a corrector with a red undertone.

Yellow: bruising

Purple/lavender correctors are best suited for eliminating yellow tones from the face. Purple also combats sallow undertones of the skin.

Brown: lentigines, melasma, seborrheic keratosis, post-inflammatory hyperpigmentation, nevi, café au lait spots

Brown is actually the hardest of all colors to correct. The deeper the pigment (ashy dermatitis, melasma) the more gray the areas appear with skin concealers. The more superficial the pigment (ephelides, lentigines), the easier it is to correct. Generally speaking, peach toned concealers work best, not beige or brown. The corrector, however, should be lighter than the skin tone or the lesion itself will appear darker.

Helping patients conceal imperfections with these simple guidelines is a great way to help relieve some anxiety and help our patients fell more confident in their skin.

Dr. Talakoub and Dr. Wesley are co-contributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected].

One of the most frustrating problems we encounter is helping patients with skin issues that we cannot immediately fix or cure. Teaching them the art of concealing skin blemishes gives patients a sense of relief. Color correction is an art and requires an understanding of basic color theory and Fitzpatrick skin type.

On the color wheel, each color sits directly across from another color, making them complementary colors.

Thoth_Adan (thinkstockimages)

If we look at red, the color opposing it is green. When red and green are combined, they neutralize each other. One of the greatest dermatologists of all time and my mentor, Timothy Berger, MD, taught me that in dermatology color “hue” is a clue to understanding morphology. Everything that is red cannot just be called “erythematous.” There is orange/red (pityriasis rosea, tinea versicolor, seborrheic dermatitis), deep red (cellulitis, Sweet’s syndrome, acne scars, rosacea, psoriasis), purple/red (vasculitis, lichen planus (LP), veins, under-eye circles), brown/red (pigmented purpura, pigmented acne scars, sarcoid).

The combination of the underlying pathology, morphology, and Fitzpatrick type is both a clue to diagnosis and a pallet for skin concealers. We can use the following techniques to help patients color correct skin imperfections:

Red: rosacea, acne scars, acne

Green-based concealers and primers are the best option to significantly reduce the redness. While green primers and correctors tend to be great for Fitzpatrick skin types I-III, a yellow-based concealer/corrector can help to cover redness on those with skin types IV-VI.

Blue: periorbital veins

If you are dealing with blue-toned skin lesions, such as periorbital veins, the ideal corrector is one with a peach or orange undertones. For skin types I-III, a peach/salmon corrector works best, whereas skin types IV-VI requires an orange-toned corrector.

Purple: under-eye circles, LP, postprocedure bruising

If under-eye circles tend to have a more purple hue to them, a yellow-based corrector works best for skin types I-III. For skin types IV-VI skin types, you will need a corrector with a red undertone.

Yellow: bruising

Purple/lavender correctors are best suited for eliminating yellow tones from the face. Purple also combats sallow undertones of the skin.

Brown: lentigines, melasma, seborrheic keratosis, post-inflammatory hyperpigmentation, nevi, café au lait spots

Brown is actually the hardest of all colors to correct. The deeper the pigment (ashy dermatitis, melasma) the more gray the areas appear with skin concealers. The more superficial the pigment (ephelides, lentigines), the easier it is to correct. Generally speaking, peach toned concealers work best, not beige or brown. The corrector, however, should be lighter than the skin tone or the lesion itself will appear darker.

Helping patients conceal imperfections with these simple guidelines is a great way to help relieve some anxiety and help our patients fell more confident in their skin.

Dr. Talakoub and Dr. Wesley are co-contributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected].

PARIS – Same-day discharge after uncomplicated transradial-access percutaneous coronary intervention (PCI) in patients with stable coronary artery disease is both feasible and safe, according to the findings of a multicenter prospective Spanish registry study.

Under the Spanish investigators’ protocol for same-day discharge, roughly three-quarters of patients successfully completed the 4- to 12-hour post-PCI surveillance period and were expeditiously sent home without spending a night in the hospital, Juan Gabriel Cordoba Soriano, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

The other 26% of patients were admitted, most often because they showed clinical instability during the surveillance period, less frequently due to a suboptimal angiographic result, explained Dr. Cordoba Soriano of the University of Albacete, Spain.

The rationale for same-day discharge post PCI – provided it has first been shown to be safe, as was the case using the Spanish criteria – is that it reduces costs by avoiding an expensive hospital bed. Also, most patients prefer to sleep in their own bed and avoid a hospital stay, he continued.

Eligibility for same-day discharge in the Spanish study was restricted to patients with stable coronary artery disease undergoing elective transradial PCI with no complications during the procedure and with clinical stability during the subsequent 4- to 12-hour observation period. Patients undergoing complex PCIs – for example, treatment of left main lesions, complex bifurcation lesions, or chronic total occlusions – were ineligible.

Why restrict eligibility to patients undergoing transradial PCI? Multiple studies convincingly show it is safer than femoral access. And outside of the United States, it is by far the more popular access route. In a show of hands, virtually all of Dr. Cordoba Soriano’s audience indicated they perform more than 70% of their PCIs via transradial access. And patients with stable CAD are less likely to experience stent thrombosis or acute occlusion of the treated artery or side branches, he continued.

Of 989 patients who presented to the three participating Spanish medical centers for elective PCI, 257 were immediately excluded from the registry because they underwent elective femoral access. That left 732 patients, 74% of whom got same-day discharge.

The same-day discharge and hospital admission groups were closely similar in terms of baseline characteristics with two exceptions: The prevalence of peripheral arterial disease in the same-day discharge group was less than half of the 10% figure in the hospitalized group, and kidney function was better in patients who ultimately received same-day discharge as evidenced by a serum creatinine of 0.9 mg/dL, half that of the hospitalized patients.

Procedural characteristics were mostly similar for the two groups as well. Although the same-day discharge group had a 26-minute shorter median procedure time, were less likely to undergo multivessel PCI, and had fewer stents implanted per patient, in a multivariate regression analysis the only independent predictors of admission post PCI were the presence of peripheral arterial disease, with an associated 2.2-fold increased risk; multivessel PCI, with a 1.8-fold risk; ad hoc as opposed to a scheduled PCI, with a 4.0-fold increased risk; and a history of prior transradial catheterization, which cut the risk of hospitalization in half.

Turning to the safety of same-day discharge, the cardiologist deemed the rate of major complications in the first 24 hours to be acceptable at 0.18% for a single case of significant bleeding. Minor complications were confined to a 1.8% incidence of hematomas greater than 5 cm in size.

The major complication rate from 24 hours to 30 days post PCI was 0.54% (two deaths, one stroke), with a 2.2% incidence of minor complications.

Dr. Cordoba Soriano noted that investigators at the Quebec Heart and Lung Institute have published a meta-analysis of 13 studies of same-day discharge after PCI totaling more than 111,000 patients (JACC Cardiovasc Interv. 2013 Feb;6[2]:99-112). The investigators concluded that a definitive randomized trial would require more than 17,000 subjects, and in the absence of such evidence same-day discharge after uncomplicated PCI “seems a reasonable approach in selected patients.”

Stanford University investigators have published a separate meta-analysis of same-day discharge after PCI in nearly 13,000 patients in 30 observational and 7 randomized controlled trials. They concluded that it appears to be as safe as overnight observation (J Am Coll Cardiol. 2013 Jul 23;62[4]:275-85).

Nevertheless, the Society for Cardiovascular Angiography and Interventions has yet to update its 2009 expert consensus document stating that the standard of care is an overnight stay following PCI (Catheter Cardiovasc Interv. 2009 Jun 1;73[7]:847-58), Dr. Cordoba Soriano observed.

He reported having no financial conflicts regarding the registry study, which was conducted with university research funds.

[email protected]

PARIS – Same-day discharge after uncomplicated transradial-access percutaneous coronary intervention (PCI) in patients with stable coronary artery disease is both feasible and safe, according to the findings of a multicenter prospective Spanish registry study.

Under the Spanish investigators’ protocol for same-day discharge, roughly three-quarters of patients successfully completed the 4- to 12-hour post-PCI surveillance period and were expeditiously sent home without spending a night in the hospital, Juan Gabriel Cordoba Soriano, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

The other 26% of patients were admitted, most often because they showed clinical instability during the surveillance period, less frequently due to a suboptimal angiographic result, explained Dr. Cordoba Soriano of the University of Albacete, Spain.

The rationale for same-day discharge post PCI – provided it has first been shown to be safe, as was the case using the Spanish criteria – is that it reduces costs by avoiding an expensive hospital bed. Also, most patients prefer to sleep in their own bed and avoid a hospital stay, he continued.

Eligibility for same-day discharge in the Spanish study was restricted to patients with stable coronary artery disease undergoing elective transradial PCI with no complications during the procedure and with clinical stability during the subsequent 4- to 12-hour observation period. Patients undergoing complex PCIs – for example, treatment of left main lesions, complex bifurcation lesions, or chronic total occlusions – were ineligible.

Why restrict eligibility to patients undergoing transradial PCI? Multiple studies convincingly show it is safer than femoral access. And outside of the United States, it is by far the more popular access route. In a show of hands, virtually all of Dr. Cordoba Soriano’s audience indicated they perform more than 70% of their PCIs via transradial access. And patients with stable CAD are less likely to experience stent thrombosis or acute occlusion of the treated artery or side branches, he continued.

Of 989 patients who presented to the three participating Spanish medical centers for elective PCI, 257 were immediately excluded from the registry because they underwent elective femoral access. That left 732 patients, 74% of whom got same-day discharge.

The same-day discharge and hospital admission groups were closely similar in terms of baseline characteristics with two exceptions: The prevalence of peripheral arterial disease in the same-day discharge group was less than half of the 10% figure in the hospitalized group, and kidney function was better in patients who ultimately received same-day discharge as evidenced by a serum creatinine of 0.9 mg/dL, half that of the hospitalized patients.

Procedural characteristics were mostly similar for the two groups as well. Although the same-day discharge group had a 26-minute shorter median procedure time, were less likely to undergo multivessel PCI, and had fewer stents implanted per patient, in a multivariate regression analysis the only independent predictors of admission post PCI were the presence of peripheral arterial disease, with an associated 2.2-fold increased risk; multivessel PCI, with a 1.8-fold risk; ad hoc as opposed to a scheduled PCI, with a 4.0-fold increased risk; and a history of prior transradial catheterization, which cut the risk of hospitalization in half.

Turning to the safety of same-day discharge, the cardiologist deemed the rate of major complications in the first 24 hours to be acceptable at 0.18% for a single case of significant bleeding. Minor complications were confined to a 1.8% incidence of hematomas greater than 5 cm in size.

The major complication rate from 24 hours to 30 days post PCI was 0.54% (two deaths, one stroke), with a 2.2% incidence of minor complications.

Dr. Cordoba Soriano noted that investigators at the Quebec Heart and Lung Institute have published a meta-analysis of 13 studies of same-day discharge after PCI totaling more than 111,000 patients (JACC Cardiovasc Interv. 2013 Feb;6[2]:99-112). The investigators concluded that a definitive randomized trial would require more than 17,000 subjects, and in the absence of such evidence same-day discharge after uncomplicated PCI “seems a reasonable approach in selected patients.”

Stanford University investigators have published a separate meta-analysis of same-day discharge after PCI in nearly 13,000 patients in 30 observational and 7 randomized controlled trials. They concluded that it appears to be as safe as overnight observation (J Am Coll Cardiol. 2013 Jul 23;62[4]:275-85).

Nevertheless, the Society for Cardiovascular Angiography and Interventions has yet to update its 2009 expert consensus document stating that the standard of care is an overnight stay following PCI (Catheter Cardiovasc Interv. 2009 Jun 1;73[7]:847-58), Dr. Cordoba Soriano observed.

He reported having no financial conflicts regarding the registry study, which was conducted with university research funds.

[email protected]

PARIS – Same-day discharge after uncomplicated transradial-access percutaneous coronary intervention (PCI) in patients with stable coronary artery disease is both feasible and safe, according to the findings of a multicenter prospective Spanish registry study.

Under the Spanish investigators’ protocol for same-day discharge, roughly three-quarters of patients successfully completed the 4- to 12-hour post-PCI surveillance period and were expeditiously sent home without spending a night in the hospital, Juan Gabriel Cordoba Soriano, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

The other 26% of patients were admitted, most often because they showed clinical instability during the surveillance period, less frequently due to a suboptimal angiographic result, explained Dr. Cordoba Soriano of the University of Albacete, Spain.

The rationale for same-day discharge post PCI – provided it has first been shown to be safe, as was the case using the Spanish criteria – is that it reduces costs by avoiding an expensive hospital bed. Also, most patients prefer to sleep in their own bed and avoid a hospital stay, he continued.

Eligibility for same-day discharge in the Spanish study was restricted to patients with stable coronary artery disease undergoing elective transradial PCI with no complications during the procedure and with clinical stability during the subsequent 4- to 12-hour observation period. Patients undergoing complex PCIs – for example, treatment of left main lesions, complex bifurcation lesions, or chronic total occlusions – were ineligible.

Why restrict eligibility to patients undergoing transradial PCI? Multiple studies convincingly show it is safer than femoral access. And outside of the United States, it is by far the more popular access route. In a show of hands, virtually all of Dr. Cordoba Soriano’s audience indicated they perform more than 70% of their PCIs via transradial access. And patients with stable CAD are less likely to experience stent thrombosis or acute occlusion of the treated artery or side branches, he continued.

Of 989 patients who presented to the three participating Spanish medical centers for elective PCI, 257 were immediately excluded from the registry because they underwent elective femoral access. That left 732 patients, 74% of whom got same-day discharge.

The same-day discharge and hospital admission groups were closely similar in terms of baseline characteristics with two exceptions: The prevalence of peripheral arterial disease in the same-day discharge group was less than half of the 10% figure in the hospitalized group, and kidney function was better in patients who ultimately received same-day discharge as evidenced by a serum creatinine of 0.9 mg/dL, half that of the hospitalized patients.

Procedural characteristics were mostly similar for the two groups as well. Although the same-day discharge group had a 26-minute shorter median procedure time, were less likely to undergo multivessel PCI, and had fewer stents implanted per patient, in a multivariate regression analysis the only independent predictors of admission post PCI were the presence of peripheral arterial disease, with an associated 2.2-fold increased risk; multivessel PCI, with a 1.8-fold risk; ad hoc as opposed to a scheduled PCI, with a 4.0-fold increased risk; and a history of prior transradial catheterization, which cut the risk of hospitalization in half.

Turning to the safety of same-day discharge, the cardiologist deemed the rate of major complications in the first 24 hours to be acceptable at 0.18% for a single case of significant bleeding. Minor complications were confined to a 1.8% incidence of hematomas greater than 5 cm in size.

The major complication rate from 24 hours to 30 days post PCI was 0.54% (two deaths, one stroke), with a 2.2% incidence of minor complications.

Dr. Cordoba Soriano noted that investigators at the Quebec Heart and Lung Institute have published a meta-analysis of 13 studies of same-day discharge after PCI totaling more than 111,000 patients (JACC Cardiovasc Interv. 2013 Feb;6[2]:99-112). The investigators concluded that a definitive randomized trial would require more than 17,000 subjects, and in the absence of such evidence same-day discharge after uncomplicated PCI “seems a reasonable approach in selected patients.”

Stanford University investigators have published a separate meta-analysis of same-day discharge after PCI in nearly 13,000 patients in 30 observational and 7 randomized controlled trials. They concluded that it appears to be as safe as overnight observation (J Am Coll Cardiol. 2013 Jul 23;62[4]:275-85).

Nevertheless, the Society for Cardiovascular Angiography and Interventions has yet to update its 2009 expert consensus document stating that the standard of care is an overnight stay following PCI (Catheter Cardiovasc Interv. 2009 Jun 1;73[7]:847-58), Dr. Cordoba Soriano observed.

He reported having no financial conflicts regarding the registry study, which was conducted with university research funds.

[email protected]

In the August podcast for The Journal of Community and Supportive Oncology, Dr David Henry discusses recent approvals by the Food and Drug Administration – for uridine triacetate as an antidote for 5-fluorouracil overdose and toxicity, and for two therapies for multiple myeloma, the monoclonal antibody elotuzumab and the proteasome inhibitor ixazomib. Also in this month’s line-up are study findings on abnormal vaginal bleeding and contraception counseling in women who are undergoing chemotherapy; the effects of IV iron treatment with ferumoxytol on health-related quality of life of patients with iron deficiency anemia; and on mindfulness-based cancer recovery in survivors recovering from chemotherapy and radiation. Two Case Reports focus on gastrointestinal cancers, one in a patients with high-grade leiomyosarcoma of the transverse colon and who presented with bowel perforation, and another on 1,25-dihydroxyvitamin D hypercalcemia and imatinib hepatotoxicity in a patient with GIST, and the New Therapies feature provides a detailed examination of recent advances in managing gynecologic cancers.

Listen to the podcast below.

In the August podcast for The Journal of Community and Supportive Oncology, Dr David Henry discusses recent approvals by the Food and Drug Administration – for uridine triacetate as an antidote for 5-fluorouracil overdose and toxicity, and for two therapies for multiple myeloma, the monoclonal antibody elotuzumab and the proteasome inhibitor ixazomib. Also in this month’s line-up are study findings on abnormal vaginal bleeding and contraception counseling in women who are undergoing chemotherapy; the effects of IV iron treatment with ferumoxytol on health-related quality of life of patients with iron deficiency anemia; and on mindfulness-based cancer recovery in survivors recovering from chemotherapy and radiation. Two Case Reports focus on gastrointestinal cancers, one in a patients with high-grade leiomyosarcoma of the transverse colon and who presented with bowel perforation, and another on 1,25-dihydroxyvitamin D hypercalcemia and imatinib hepatotoxicity in a patient with GIST, and the New Therapies feature provides a detailed examination of recent advances in managing gynecologic cancers.

Listen to the podcast below.

In the August podcast for The Journal of Community and Supportive Oncology, Dr David Henry discusses recent approvals by the Food and Drug Administration – for uridine triacetate as an antidote for 5-fluorouracil overdose and toxicity, and for two therapies for multiple myeloma, the monoclonal antibody elotuzumab and the proteasome inhibitor ixazomib. Also in this month’s line-up are study findings on abnormal vaginal bleeding and contraception counseling in women who are undergoing chemotherapy; the effects of IV iron treatment with ferumoxytol on health-related quality of life of patients with iron deficiency anemia; and on mindfulness-based cancer recovery in survivors recovering from chemotherapy and radiation. Two Case Reports focus on gastrointestinal cancers, one in a patients with high-grade leiomyosarcoma of the transverse colon and who presented with bowel perforation, and another on 1,25-dihydroxyvitamin D hypercalcemia and imatinib hepatotoxicity in a patient with GIST, and the New Therapies feature provides a detailed examination of recent advances in managing gynecologic cancers.

Listen to the podcast below.

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Projected growth in the HIV provider workforce by 2019 will not accommodate the increased number of HIV-infected persons requiring care, according to a study in Clinical Infectious Diseases. The authors said facilities funded by the Ryan White HIV/AIDS Program may face attrition of highly qualified providers.

©alexskopje/ThinkStock.com

South African HIV-infected children receiving antiretroviral therapy have lower bone mass, compared with HIV-uninfected controls, according to a study by the CHANGES Bone Study group. The authors said accrued bone mass is positively associated with switching to efavirenz-based ART, compared with remaining on ritonavir-boosted lopinavir.

Sexually transmitted infection acquisition in HIV-infected adolescents and young adults is associated with older age, female sex, nonperinatal HIV acquisition, and poorly controlled HIV infection, according to a study in the Journal of the Pediatric Infectious Diseases Society.

A study in the journal AIDS found that viral escape in the Nef peptide is elevated preferentially in STEP vaccine–treated individuals, suggesting that vaccination primarily modulated initial cytotoxic T-lymphocyte responses.

A clinical HIV vaccine trial found that vaccination was associated with increases in HIV cell-associated RNA and HIV-specific responses during antiretroviral therapy.

The European Medicines Agency (EMA) has recommended granting a marketing authorization in the European Union (EU) for Truvada (emtricitabine/tenofovir disoproxil) for preexposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Five-year outcomes from the IMPAACT-P1060 trial of HIV-infected antiretroviral-eligible children supported the WHO recommendation of lopinavir/ritonavir (LPV/r) in first-line ART regimens for HIV-infected children.

A systematic review of medical literature, published in Tropical Medicine & International Health, found that rigorously evaluated interventions for adult posttraumatic stress disorder in people living with HIV are rare.

HIV-infected adolescents and young adults are vulnerable to virologic failure, especially during the transitional period, a recent study found. The authors said identification of HIV-infected adolescents at high risk for virologic failure might help to improve treatment success.

Treatment for HIV infection can be started on the day of diagnosis without impacting the safety or acceptability of antiretroviral therapy, according to a study in JAIDS, and may shorten the time to virologic suppression.

New research indicates that Measurement-Based Care (MBC) interventions on depression, if implemented among HIV-infected depressed adults in routine care, may be less effective than in randomized controlled trials but can still be expected to reduce depression.

A study published in Mycoses revealed that H. capsulatum is an important agent of disseminated disease in AIDS patients in Brazil. The authors said this reinforces the importance of making available modern diagnostic tests as well as safer antifungal agents for the treatment of histoplasmosis.

An epidemiologic analysis indicates that substantial decreases in HIV incidence are possible in South Africa from sufficient uptake of both primary prevention and antiretroviral therapy, but with continuation of the status quo, HIV elimination in the country is unlikely within a 50-year time scale.

A meta-analysis showed a consistent increased risk of mortality for HIV-exposed uninfected vs. HIV-unexposed uninfected infants and children, although the authors said longitudinal research is needed to elucidate underlying mechanisms, which may help explain the differences in mortality.

A number of factors can identify HIV-infected patients at low risk of rebound with protease inhibitor (PI) monotherapy, said investigators in the PIVOT trial, and this may help to better target those who may benefit from this management strategy.

Concomitant administration of cytotoxic chemotherapy and combination antiretroviral therapy does not induce expression of membrane drug transporter protein (MTP) in HIV-infected patients, according to a study in HIV Clinical Trials. The authors said no significant changes in viral resistance were observed before and after chemotherapy, suggesting mutagenic cytotoxic chemotherapy seems not to induce mutations in HIV pro-viral DNA.

A study of HIV-infected patients with cryptococcal meningitis in the Ivory Coast revealed a high genetic diversity among Cryptococcus isolates, the occurrence of mixed infections and a high antifungal susceptibility for the majority of Ivorian cryptococcal isolates.

A Zambian study found no associations between hormonal contraception use among HIV-positive women and the risk of female-to-male HIV transmission.

Despite late presentation to HIV care, foreign-born persons can subsequently engage in their own HIV care as well as U.S.-born persons, according to a study in AIDS Care. The authors recommend interventions that promote HIV screening in foreign-born persons as a promising way to improve outcomes in these populations.

[email protected]

On Twitter @richpizzi

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Projected growth in the HIV provider workforce by 2019 will not accommodate the increased number of HIV-infected persons requiring care, according to a study in Clinical Infectious Diseases. The authors said facilities funded by the Ryan White HIV/AIDS Program may face attrition of highly qualified providers.

©alexskopje/ThinkStock.com

South African HIV-infected children receiving antiretroviral therapy have lower bone mass, compared with HIV-uninfected controls, according to a study by the CHANGES Bone Study group. The authors said accrued bone mass is positively associated with switching to efavirenz-based ART, compared with remaining on ritonavir-boosted lopinavir.

Sexually transmitted infection acquisition in HIV-infected adolescents and young adults is associated with older age, female sex, nonperinatal HIV acquisition, and poorly controlled HIV infection, according to a study in the Journal of the Pediatric Infectious Diseases Society.

A study in the journal AIDS found that viral escape in the Nef peptide is elevated preferentially in STEP vaccine–treated individuals, suggesting that vaccination primarily modulated initial cytotoxic T-lymphocyte responses.

A clinical HIV vaccine trial found that vaccination was associated with increases in HIV cell-associated RNA and HIV-specific responses during antiretroviral therapy.

The European Medicines Agency (EMA) has recommended granting a marketing authorization in the European Union (EU) for Truvada (emtricitabine/tenofovir disoproxil) for preexposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Five-year outcomes from the IMPAACT-P1060 trial of HIV-infected antiretroviral-eligible children supported the WHO recommendation of lopinavir/ritonavir (LPV/r) in first-line ART regimens for HIV-infected children.

A systematic review of medical literature, published in Tropical Medicine & International Health, found that rigorously evaluated interventions for adult posttraumatic stress disorder in people living with HIV are rare.

HIV-infected adolescents and young adults are vulnerable to virologic failure, especially during the transitional period, a recent study found. The authors said identification of HIV-infected adolescents at high risk for virologic failure might help to improve treatment success.

Treatment for HIV infection can be started on the day of diagnosis without impacting the safety or acceptability of antiretroviral therapy, according to a study in JAIDS, and may shorten the time to virologic suppression.

New research indicates that Measurement-Based Care (MBC) interventions on depression, if implemented among HIV-infected depressed adults in routine care, may be less effective than in randomized controlled trials but can still be expected to reduce depression.

A study published in Mycoses revealed that H. capsulatum is an important agent of disseminated disease in AIDS patients in Brazil. The authors said this reinforces the importance of making available modern diagnostic tests as well as safer antifungal agents for the treatment of histoplasmosis.

An epidemiologic analysis indicates that substantial decreases in HIV incidence are possible in South Africa from sufficient uptake of both primary prevention and antiretroviral therapy, but with continuation of the status quo, HIV elimination in the country is unlikely within a 50-year time scale.

A meta-analysis showed a consistent increased risk of mortality for HIV-exposed uninfected vs. HIV-unexposed uninfected infants and children, although the authors said longitudinal research is needed to elucidate underlying mechanisms, which may help explain the differences in mortality.

A number of factors can identify HIV-infected patients at low risk of rebound with protease inhibitor (PI) monotherapy, said investigators in the PIVOT trial, and this may help to better target those who may benefit from this management strategy.

Concomitant administration of cytotoxic chemotherapy and combination antiretroviral therapy does not induce expression of membrane drug transporter protein (MTP) in HIV-infected patients, according to a study in HIV Clinical Trials. The authors said no significant changes in viral resistance were observed before and after chemotherapy, suggesting mutagenic cytotoxic chemotherapy seems not to induce mutations in HIV pro-viral DNA.

A study of HIV-infected patients with cryptococcal meningitis in the Ivory Coast revealed a high genetic diversity among Cryptococcus isolates, the occurrence of mixed infections and a high antifungal susceptibility for the majority of Ivorian cryptococcal isolates.

A Zambian study found no associations between hormonal contraception use among HIV-positive women and the risk of female-to-male HIV transmission.

Despite late presentation to HIV care, foreign-born persons can subsequently engage in their own HIV care as well as U.S.-born persons, according to a study in AIDS Care. The authors recommend interventions that promote HIV screening in foreign-born persons as a promising way to improve outcomes in these populations.

[email protected]

On Twitter @richpizzi

A great volume of HIV and AIDS research enters the medical literature every month. It’s difficult to monitor everything, so here’s a quick look at some notable news items and journal articles published over the past few weeks.

Projected growth in the HIV provider workforce by 2019 will not accommodate the increased number of HIV-infected persons requiring care, according to a study in Clinical Infectious Diseases. The authors said facilities funded by the Ryan White HIV/AIDS Program may face attrition of highly qualified providers.

©alexskopje/ThinkStock.com

South African HIV-infected children receiving antiretroviral therapy have lower bone mass, compared with HIV-uninfected controls, according to a study by the CHANGES Bone Study group. The authors said accrued bone mass is positively associated with switching to efavirenz-based ART, compared with remaining on ritonavir-boosted lopinavir.

Sexually transmitted infection acquisition in HIV-infected adolescents and young adults is associated with older age, female sex, nonperinatal HIV acquisition, and poorly controlled HIV infection, according to a study in the Journal of the Pediatric Infectious Diseases Society.

A study in the journal AIDS found that viral escape in the Nef peptide is elevated preferentially in STEP vaccine–treated individuals, suggesting that vaccination primarily modulated initial cytotoxic T-lymphocyte responses.

A clinical HIV vaccine trial found that vaccination was associated with increases in HIV cell-associated RNA and HIV-specific responses during antiretroviral therapy.

The European Medicines Agency (EMA) has recommended granting a marketing authorization in the European Union (EU) for Truvada (emtricitabine/tenofovir disoproxil) for preexposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Five-year outcomes from the IMPAACT-P1060 trial of HIV-infected antiretroviral-eligible children supported the WHO recommendation of lopinavir/ritonavir (LPV/r) in first-line ART regimens for HIV-infected children.

A systematic review of medical literature, published in Tropical Medicine & International Health, found that rigorously evaluated interventions for adult posttraumatic stress disorder in people living with HIV are rare.

HIV-infected adolescents and young adults are vulnerable to virologic failure, especially during the transitional period, a recent study found. The authors said identification of HIV-infected adolescents at high risk for virologic failure might help to improve treatment success.

Treatment for HIV infection can be started on the day of diagnosis without impacting the safety or acceptability of antiretroviral therapy, according to a study in JAIDS, and may shorten the time to virologic suppression.

New research indicates that Measurement-Based Care (MBC) interventions on depression, if implemented among HIV-infected depressed adults in routine care, may be less effective than in randomized controlled trials but can still be expected to reduce depression.

A study published in Mycoses revealed that H. capsulatum is an important agent of disseminated disease in AIDS patients in Brazil. The authors said this reinforces the importance of making available modern diagnostic tests as well as safer antifungal agents for the treatment of histoplasmosis.

An epidemiologic analysis indicates that substantial decreases in HIV incidence are possible in South Africa from sufficient uptake of both primary prevention and antiretroviral therapy, but with continuation of the status quo, HIV elimination in the country is unlikely within a 50-year time scale.

A meta-analysis showed a consistent increased risk of mortality for HIV-exposed uninfected vs. HIV-unexposed uninfected infants and children, although the authors said longitudinal research is needed to elucidate underlying mechanisms, which may help explain the differences in mortality.

A number of factors can identify HIV-infected patients at low risk of rebound with protease inhibitor (PI) monotherapy, said investigators in the PIVOT trial, and this may help to better target those who may benefit from this management strategy.

Concomitant administration of cytotoxic chemotherapy and combination antiretroviral therapy does not induce expression of membrane drug transporter protein (MTP) in HIV-infected patients, according to a study in HIV Clinical Trials. The authors said no significant changes in viral resistance were observed before and after chemotherapy, suggesting mutagenic cytotoxic chemotherapy seems not to induce mutations in HIV pro-viral DNA.

A study of HIV-infected patients with cryptococcal meningitis in the Ivory Coast revealed a high genetic diversity among Cryptococcus isolates, the occurrence of mixed infections and a high antifungal susceptibility for the majority of Ivorian cryptococcal isolates.

A Zambian study found no associations between hormonal contraception use among HIV-positive women and the risk of female-to-male HIV transmission.

Despite late presentation to HIV care, foreign-born persons can subsequently engage in their own HIV care as well as U.S.-born persons, according to a study in AIDS Care. The authors recommend interventions that promote HIV screening in foreign-born persons as a promising way to improve outcomes in these populations.

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