Deepak Chitnis

WASHINGTON – Treatment of acute migraine in pediatric patients needs substantial improvement, particularly from providers in metropolitan areas, according to a retrospective observational study presented at the annual meeting of the American Headache Society.

“We know that there are practice parameters outlined by the [American Academy of Neurology] and other organizations, that there are expert recommendations, and [Food and Drug Administration]-approved medications,” said Robert A. Nicholson, Ph.D., director of behavioral medicine at Mercy Clinic Headache Center, St. Louis. “So there is definitely useful and effective treatment information available for dealing with pediatric migraine patients.”

©Jupiterimages/Thinkstockphotos.com

Dr. Nicholson and his coinvestigators collected electronic health records data on 94,444 cases in children aged 6-17 years, including 32,926 children in the study. All subjects presented with primary migraine and headache to 1 of 1,617 metropolitan and nonmetropolitan primary care, specialty care, or emergency departments between January 2009 and June 2014. Children were included based on a multi-input inclusion algorithm, which “determined presence of primary migraine, headache, or undiagnosed primary migraine,” and were excluded for post-traumatic presentation, neoplasms, pregnancy, and “infectious conditions for which headache was secondary.”

Just 16.1% of children received evidence-based medications for their acute migraine, while 37.9% received other medication and 46% did not receive any medication at all. Furthermore, 45.7% of subjects did not receive any diagnosis when they presented; only 17.7% were diagnosed with a migraine, while 36.6% received a headache diagnosis. Evidence-based medications most commonly prescribed were NSAIDs, triptans, and acetaminophen.

The percentage of children who received medication improved as they got older, with those aged 15-17 years receiving diagnoses and medications more consistently. Children who received the correct diagnosis at a younger age were better off in terms of getting medication more consistently as they aged.

“We see here that migraine does go up over time, but even in the best-case scenario, only about one out of four kids who are 15-17 [years] get evidence-based medication,” said Dr. Nicholson. “So although we find that there is a decrease in migraines as kids get older, it’s not as if we suddenly find some magical point at which they receive optimal treatment, it’s just that treatment gets less woeful than it was when kids are younger.”

Nearly 57% of subjects were female, and over 78% were white. Providers were predominantly located in metropolitan areas (78.2% vs. 21.8% nonmetropolitan) and 64.6% of centers were primary centers, 26.5% were emergency or urgent care departments, and 9% were specialty.

“We also found that providers in metropolitan areas were less likely to prescribe evidence-based medicine,” he said. “We don’t yet know much about that, [but] we’re going to do more work on that, as it’s something we found that we thought would be the exact opposite.”

Dr. Nicholson acknowledged the Migraine Research Foundation and the Mercy Research/MTS for their support of this study. He did not report any other relevant disclosures.

[email protected]

WASHINGTON – Treatment of acute migraine in pediatric patients needs substantial improvement, particularly from providers in metropolitan areas, according to a retrospective observational study presented at the annual meeting of the American Headache Society.

“We know that there are practice parameters outlined by the [American Academy of Neurology] and other organizations, that there are expert recommendations, and [Food and Drug Administration]-approved medications,” said Robert A. Nicholson, Ph.D., director of behavioral medicine at Mercy Clinic Headache Center, St. Louis. “So there is definitely useful and effective treatment information available for dealing with pediatric migraine patients.”

©Jupiterimages/Thinkstockphotos.com

Dr. Nicholson and his coinvestigators collected electronic health records data on 94,444 cases in children aged 6-17 years, including 32,926 children in the study. All subjects presented with primary migraine and headache to 1 of 1,617 metropolitan and nonmetropolitan primary care, specialty care, or emergency departments between January 2009 and June 2014. Children were included based on a multi-input inclusion algorithm, which “determined presence of primary migraine, headache, or undiagnosed primary migraine,” and were excluded for post-traumatic presentation, neoplasms, pregnancy, and “infectious conditions for which headache was secondary.”

Just 16.1% of children received evidence-based medications for their acute migraine, while 37.9% received other medication and 46% did not receive any medication at all. Furthermore, 45.7% of subjects did not receive any diagnosis when they presented; only 17.7% were diagnosed with a migraine, while 36.6% received a headache diagnosis. Evidence-based medications most commonly prescribed were NSAIDs, triptans, and acetaminophen.

The percentage of children who received medication improved as they got older, with those aged 15-17 years receiving diagnoses and medications more consistently. Children who received the correct diagnosis at a younger age were better off in terms of getting medication more consistently as they aged.

“We see here that migraine does go up over time, but even in the best-case scenario, only about one out of four kids who are 15-17 [years] get evidence-based medication,” said Dr. Nicholson. “So although we find that there is a decrease in migraines as kids get older, it’s not as if we suddenly find some magical point at which they receive optimal treatment, it’s just that treatment gets less woeful than it was when kids are younger.”

Nearly 57% of subjects were female, and over 78% were white. Providers were predominantly located in metropolitan areas (78.2% vs. 21.8% nonmetropolitan) and 64.6% of centers were primary centers, 26.5% were emergency or urgent care departments, and 9% were specialty.

“We also found that providers in metropolitan areas were less likely to prescribe evidence-based medicine,” he said. “We don’t yet know much about that, [but] we’re going to do more work on that, as it’s something we found that we thought would be the exact opposite.”

Dr. Nicholson acknowledged the Migraine Research Foundation and the Mercy Research/MTS for their support of this study. He did not report any other relevant disclosures.

[email protected]

WASHINGTON – Treatment of acute migraine in pediatric patients needs substantial improvement, particularly from providers in metropolitan areas, according to a retrospective observational study presented at the annual meeting of the American Headache Society.

“We know that there are practice parameters outlined by the [American Academy of Neurology] and other organizations, that there are expert recommendations, and [Food and Drug Administration]-approved medications,” said Robert A. Nicholson, Ph.D., director of behavioral medicine at Mercy Clinic Headache Center, St. Louis. “So there is definitely useful and effective treatment information available for dealing with pediatric migraine patients.”

©Jupiterimages/Thinkstockphotos.com

Dr. Nicholson and his coinvestigators collected electronic health records data on 94,444 cases in children aged 6-17 years, including 32,926 children in the study. All subjects presented with primary migraine and headache to 1 of 1,617 metropolitan and nonmetropolitan primary care, specialty care, or emergency departments between January 2009 and June 2014. Children were included based on a multi-input inclusion algorithm, which “determined presence of primary migraine, headache, or undiagnosed primary migraine,” and were excluded for post-traumatic presentation, neoplasms, pregnancy, and “infectious conditions for which headache was secondary.”

Just 16.1% of children received evidence-based medications for their acute migraine, while 37.9% received other medication and 46% did not receive any medication at all. Furthermore, 45.7% of subjects did not receive any diagnosis when they presented; only 17.7% were diagnosed with a migraine, while 36.6% received a headache diagnosis. Evidence-based medications most commonly prescribed were NSAIDs, triptans, and acetaminophen.

The percentage of children who received medication improved as they got older, with those aged 15-17 years receiving diagnoses and medications more consistently. Children who received the correct diagnosis at a younger age were better off in terms of getting medication more consistently as they aged.

“We see here that migraine does go up over time, but even in the best-case scenario, only about one out of four kids who are 15-17 [years] get evidence-based medication,” said Dr. Nicholson. “So although we find that there is a decrease in migraines as kids get older, it’s not as if we suddenly find some magical point at which they receive optimal treatment, it’s just that treatment gets less woeful than it was when kids are younger.”

Nearly 57% of subjects were female, and over 78% were white. Providers were predominantly located in metropolitan areas (78.2% vs. 21.8% nonmetropolitan) and 64.6% of centers were primary centers, 26.5% were emergency or urgent care departments, and 9% were specialty.

“We also found that providers in metropolitan areas were less likely to prescribe evidence-based medicine,” he said. “We don’t yet know much about that, [but] we’re going to do more work on that, as it’s something we found that we thought would be the exact opposite.”

Dr. Nicholson acknowledged the Migraine Research Foundation and the Mercy Research/MTS for their support of this study. He did not report any other relevant disclosures.

[email protected]

WASHINGTON – Chronic migraine can have a noticeable impact on child-rearing and affect the overall quality of care provided to children by an afflicted parent or domestic partner, according to findings from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study presented at the annual meeting of the American Headache Society.

“Limited data exists on the burden of migraine on family members, [but] no one has actually studied the burden to family members of chronic migraine,” explained Dawn C. Buse, Ph.D., of the Albert Einstein College of Medicine in New York.

©Getty Images

The CaMEO study was initiated in the fall of 2012 as a prospective, web-based study that surveyed individuals with migraine and chronic migraine, with “cross-sectional modules embedded in a longitudinal design.” This module, called by investigators the Family Burden module, surveyed 13,064 individuals with migraine, of whom 994 met the criteria for chronic migraine – that is, subjects experienced at least 15 headache days per month for the last 3 months.

To assess the burden of chronic migraine on children and other family members, subjects and their partners/spouses responded to questions designed for exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). The questions covered reduced participation in, or enjoyment of, family activities; missed or canceled family events; effects of migraine on family members’ activities and emotions; and effect of migraine on migraineur’s interaction with children. Each question was answered with a number of 1-4, with 1 being complete disagreement and 4 being complete agreement.

“We also collected data directly from children who were age 13 and older,” said Dr. Buse. “That data, however, will be coming out next year.”

Unsurprisingly, 75.1% of migraine sufferers said that the noise of their child’s activities can cause or aggravate their headaches, but 66% said they get more easily angry or annoyed with their children when they have a headache, and 71.7% of parents said that they would be a better parent if they did not have chromic migraines.

For questions pertaining to participation and enjoyment of family events, 44.4% of migraineurs and 19.6% of partners “somewhat or completely” agreed that their migraines reduced their ability to properly parent their children. Forty-nine percent of migraneurs responded that chronic migraines reduced their enjoyment of children’s activities, 56.5% said that chronic migraines reduced their enjoyment of a significant event in the past year, and 65.3% said that migraines reduced their enjoyment of family activities.

Nearly 39% of subjects experiencing chronic migraines said that the affliction caused them to miss a holiday in the last year, 39% canceled an important holiday celebration in their own home over the last year, 33% said their children missed a scheduled activity in the last 30 days due to their parent’s migraine, and 33.9% said their children either missed a day of school or was dropped off/picked up late because the parent had a migraine.

Almost 32% of partners said that migraineurs were more demanding of their children because of their migraine, while 30.3% of subjects with migraines said that it has caused conflict between them and their children. Thirty percent of migraineurs said that the condition causes stress with their children, regardless of whether they’ve actually experienced a headache that day.

“Probands with chronic migraine and their spouses perceive a higher rate of burden on children,” Dr. Buse concluded. “Generally, the probands are harder on themselves than their spouses are; probands feel guiltier, sadder, angrier, more frustrated, or that their kids are more affected than their spouses perceive, and going forward, we’ll be analyzing what the kids say themselves.”

The CaMEO study was sponsored by Allergan. Dr. Buse disclosed that she has received grant support and honoraria from Allergan, the American Headache Society, and the National Headache Foundation; that she is an employee of Montefiore Medical Center, which has received research support funded by Allergan, CoLucid, Endo Pharmaceuticals, GlaxoSmithKline, MAP Pharmaceuticals, Merck, NuPathe, Novartis, Ortho-McNeil, and Zogenix, both directly and via grants from the National Headache Foundation.

[email protected]

WASHINGTON – Chronic migraine can have a noticeable impact on child-rearing and affect the overall quality of care provided to children by an afflicted parent or domestic partner, according to findings from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study presented at the annual meeting of the American Headache Society.

“Limited data exists on the burden of migraine on family members, [but] no one has actually studied the burden to family members of chronic migraine,” explained Dawn C. Buse, Ph.D., of the Albert Einstein College of Medicine in New York.

©Getty Images

The CaMEO study was initiated in the fall of 2012 as a prospective, web-based study that surveyed individuals with migraine and chronic migraine, with “cross-sectional modules embedded in a longitudinal design.” This module, called by investigators the Family Burden module, surveyed 13,064 individuals with migraine, of whom 994 met the criteria for chronic migraine – that is, subjects experienced at least 15 headache days per month for the last 3 months.

To assess the burden of chronic migraine on children and other family members, subjects and their partners/spouses responded to questions designed for exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). The questions covered reduced participation in, or enjoyment of, family activities; missed or canceled family events; effects of migraine on family members’ activities and emotions; and effect of migraine on migraineur’s interaction with children. Each question was answered with a number of 1-4, with 1 being complete disagreement and 4 being complete agreement.

“We also collected data directly from children who were age 13 and older,” said Dr. Buse. “That data, however, will be coming out next year.”

Unsurprisingly, 75.1% of migraine sufferers said that the noise of their child’s activities can cause or aggravate their headaches, but 66% said they get more easily angry or annoyed with their children when they have a headache, and 71.7% of parents said that they would be a better parent if they did not have chromic migraines.

For questions pertaining to participation and enjoyment of family events, 44.4% of migraineurs and 19.6% of partners “somewhat or completely” agreed that their migraines reduced their ability to properly parent their children. Forty-nine percent of migraneurs responded that chronic migraines reduced their enjoyment of children’s activities, 56.5% said that chronic migraines reduced their enjoyment of a significant event in the past year, and 65.3% said that migraines reduced their enjoyment of family activities.

Nearly 39% of subjects experiencing chronic migraines said that the affliction caused them to miss a holiday in the last year, 39% canceled an important holiday celebration in their own home over the last year, 33% said their children missed a scheduled activity in the last 30 days due to their parent’s migraine, and 33.9% said their children either missed a day of school or was dropped off/picked up late because the parent had a migraine.

Almost 32% of partners said that migraineurs were more demanding of their children because of their migraine, while 30.3% of subjects with migraines said that it has caused conflict between them and their children. Thirty percent of migraineurs said that the condition causes stress with their children, regardless of whether they’ve actually experienced a headache that day.

“Probands with chronic migraine and their spouses perceive a higher rate of burden on children,” Dr. Buse concluded. “Generally, the probands are harder on themselves than their spouses are; probands feel guiltier, sadder, angrier, more frustrated, or that their kids are more affected than their spouses perceive, and going forward, we’ll be analyzing what the kids say themselves.”

The CaMEO study was sponsored by Allergan. Dr. Buse disclosed that she has received grant support and honoraria from Allergan, the American Headache Society, and the National Headache Foundation; that she is an employee of Montefiore Medical Center, which has received research support funded by Allergan, CoLucid, Endo Pharmaceuticals, GlaxoSmithKline, MAP Pharmaceuticals, Merck, NuPathe, Novartis, Ortho-McNeil, and Zogenix, both directly and via grants from the National Headache Foundation.

[email protected]

WASHINGTON – Chronic migraine can have a noticeable impact on child-rearing and affect the overall quality of care provided to children by an afflicted parent or domestic partner, according to findings from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study presented at the annual meeting of the American Headache Society.

“Limited data exists on the burden of migraine on family members, [but] no one has actually studied the burden to family members of chronic migraine,” explained Dawn C. Buse, Ph.D., of the Albert Einstein College of Medicine in New York.

©Getty Images

The CaMEO study was initiated in the fall of 2012 as a prospective, web-based study that surveyed individuals with migraine and chronic migraine, with “cross-sectional modules embedded in a longitudinal design.” This module, called by investigators the Family Burden module, surveyed 13,064 individuals with migraine, of whom 994 met the criteria for chronic migraine – that is, subjects experienced at least 15 headache days per month for the last 3 months.

To assess the burden of chronic migraine on children and other family members, subjects and their partners/spouses responded to questions designed for exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). The questions covered reduced participation in, or enjoyment of, family activities; missed or canceled family events; effects of migraine on family members’ activities and emotions; and effect of migraine on migraineur’s interaction with children. Each question was answered with a number of 1-4, with 1 being complete disagreement and 4 being complete agreement.

“We also collected data directly from children who were age 13 and older,” said Dr. Buse. “That data, however, will be coming out next year.”

Unsurprisingly, 75.1% of migraine sufferers said that the noise of their child’s activities can cause or aggravate their headaches, but 66% said they get more easily angry or annoyed with their children when they have a headache, and 71.7% of parents said that they would be a better parent if they did not have chromic migraines.

For questions pertaining to participation and enjoyment of family events, 44.4% of migraineurs and 19.6% of partners “somewhat or completely” agreed that their migraines reduced their ability to properly parent their children. Forty-nine percent of migraneurs responded that chronic migraines reduced their enjoyment of children’s activities, 56.5% said that chronic migraines reduced their enjoyment of a significant event in the past year, and 65.3% said that migraines reduced their enjoyment of family activities.

Nearly 39% of subjects experiencing chronic migraines said that the affliction caused them to miss a holiday in the last year, 39% canceled an important holiday celebration in their own home over the last year, 33% said their children missed a scheduled activity in the last 30 days due to their parent’s migraine, and 33.9% said their children either missed a day of school or was dropped off/picked up late because the parent had a migraine.

Almost 32% of partners said that migraineurs were more demanding of their children because of their migraine, while 30.3% of subjects with migraines said that it has caused conflict between them and their children. Thirty percent of migraineurs said that the condition causes stress with their children, regardless of whether they’ve actually experienced a headache that day.

“Probands with chronic migraine and their spouses perceive a higher rate of burden on children,” Dr. Buse concluded. “Generally, the probands are harder on themselves than their spouses are; probands feel guiltier, sadder, angrier, more frustrated, or that their kids are more affected than their spouses perceive, and going forward, we’ll be analyzing what the kids say themselves.”

The CaMEO study was sponsored by Allergan. Dr. Buse disclosed that she has received grant support and honoraria from Allergan, the American Headache Society, and the National Headache Foundation; that she is an employee of Montefiore Medical Center, which has received research support funded by Allergan, CoLucid, Endo Pharmaceuticals, GlaxoSmithKline, MAP Pharmaceuticals, Merck, NuPathe, Novartis, Ortho-McNeil, and Zogenix, both directly and via grants from the National Headache Foundation.

[email protected]

PHILADELPHIA – Drug-induced liver injury (DILI) continues to be a hot topic, but new advances have helped increase the amount of research done and improve the quality of treatment for patients suffering from the condition.

“It’s been 10 years since the DILI Network was started at [the National Institutes of Health], and it’s giving us a lot of important information about what’s happening with [DILI] in the United States,” explained Dr. James H. Lewis of Georgetown University in Washington, D.C. “However, we are still playing catch up with many nations around the world, who have had similar registries for a longer time.”

While incidents of DILI and, more important, severe DILI, continue to be low in the United States, DILI is the leading cause of acute liver failure in Americans, and a major cause of emergency liver transplant. Further research into new drugs is stymied by hepatoxicity, which is “the main reason why many drugs are pulled from development.”

“When it comes to drugs that are causing injury, these are fairly old friends,” said Dr. Lewis. “They’ve been around for a long time and they don’t change a whole lot, Very interesting [is] that the TB drugs lead the list, especially INH [isoniazid] and pyrazinamide, as well as antibiotics, especially augmentin.”

Nevertheless, activity continues to increase in the DILI field. Looking at PubMed, said Dr. Lewis, there are already over 300 citations involving DILI from January through April of this year, over 1,500 in all of 2014, and over 6,000 from 2010 to 2014. Compared to that, there were around 7,000 in total from 2000 to 2009.

The relationship between dosage and likelihood of liver injury still needs examination, declared Dr. Lewis, citing separate works done by Dr. Hy Zimmerman and Dr. Jack Uetretcht. The former determined that there were certain drugs for which the likelihood of liver injury could be predicted, such as acetaminophen, and those for which such risk was idiosyncratic.

Dr. Uetrecht determined that 10-mg doses were the cutoff at which liver injury became possible. In 2008, work by Lammert et al., published in Hepatology, revealed that doses of 10 mg or less resulted in a 9% risk of DILI, compared with 14.2% for doses of 11-49 mg, and 77% for doses at or above 50 mg. “There are over 200 drugs that have been found to cause DILI, but the top 10 alone account for 50% of all DILI, and the top 25 drugs account for [67%],” said Dr. Lewis. “This means that the other 175 drugs have maybe one case of DILI in the [DILI Network] entire database.”

What this means, concluded Dr. Lewis, is that DILI does not occur often with most drugs, and the ones that cause it are those that are already known.

Dr. Lewis disclosed receiving grant/research support from Ocera Therapeutics, Inc.; consultant relationships with GlaxoSmithKline, Otsuka Pharmaceutical Co. Ltd., Takeda Pharmaceuticals U.S.A. Inc., AstraZeneca, and Lundbeck Inc.; and being a member of the speaking bureau for Gilead Science, Inc.

[email protected]

PHILADELPHIA – Drug-induced liver injury (DILI) continues to be a hot topic, but new advances have helped increase the amount of research done and improve the quality of treatment for patients suffering from the condition.

“It’s been 10 years since the DILI Network was started at [the National Institutes of Health], and it’s giving us a lot of important information about what’s happening with [DILI] in the United States,” explained Dr. James H. Lewis of Georgetown University in Washington, D.C. “However, we are still playing catch up with many nations around the world, who have had similar registries for a longer time.”

While incidents of DILI and, more important, severe DILI, continue to be low in the United States, DILI is the leading cause of acute liver failure in Americans, and a major cause of emergency liver transplant. Further research into new drugs is stymied by hepatoxicity, which is “the main reason why many drugs are pulled from development.”

“When it comes to drugs that are causing injury, these are fairly old friends,” said Dr. Lewis. “They’ve been around for a long time and they don’t change a whole lot, Very interesting [is] that the TB drugs lead the list, especially INH [isoniazid] and pyrazinamide, as well as antibiotics, especially augmentin.”

Nevertheless, activity continues to increase in the DILI field. Looking at PubMed, said Dr. Lewis, there are already over 300 citations involving DILI from January through April of this year, over 1,500 in all of 2014, and over 6,000 from 2010 to 2014. Compared to that, there were around 7,000 in total from 2000 to 2009.

The relationship between dosage and likelihood of liver injury still needs examination, declared Dr. Lewis, citing separate works done by Dr. Hy Zimmerman and Dr. Jack Uetretcht. The former determined that there were certain drugs for which the likelihood of liver injury could be predicted, such as acetaminophen, and those for which such risk was idiosyncratic.

Dr. Uetrecht determined that 10-mg doses were the cutoff at which liver injury became possible. In 2008, work by Lammert et al., published in Hepatology, revealed that doses of 10 mg or less resulted in a 9% risk of DILI, compared with 14.2% for doses of 11-49 mg, and 77% for doses at or above 50 mg. “There are over 200 drugs that have been found to cause DILI, but the top 10 alone account for 50% of all DILI, and the top 25 drugs account for [67%],” said Dr. Lewis. “This means that the other 175 drugs have maybe one case of DILI in the [DILI Network] entire database.”

What this means, concluded Dr. Lewis, is that DILI does not occur often with most drugs, and the ones that cause it are those that are already known.

Dr. Lewis disclosed receiving grant/research support from Ocera Therapeutics, Inc.; consultant relationships with GlaxoSmithKline, Otsuka Pharmaceutical Co. Ltd., Takeda Pharmaceuticals U.S.A. Inc., AstraZeneca, and Lundbeck Inc.; and being a member of the speaking bureau for Gilead Science, Inc.

[email protected]

PHILADELPHIA – Drug-induced liver injury (DILI) continues to be a hot topic, but new advances have helped increase the amount of research done and improve the quality of treatment for patients suffering from the condition.

“It’s been 10 years since the DILI Network was started at [the National Institutes of Health], and it’s giving us a lot of important information about what’s happening with [DILI] in the United States,” explained Dr. James H. Lewis of Georgetown University in Washington, D.C. “However, we are still playing catch up with many nations around the world, who have had similar registries for a longer time.”

While incidents of DILI and, more important, severe DILI, continue to be low in the United States, DILI is the leading cause of acute liver failure in Americans, and a major cause of emergency liver transplant. Further research into new drugs is stymied by hepatoxicity, which is “the main reason why many drugs are pulled from development.”

“When it comes to drugs that are causing injury, these are fairly old friends,” said Dr. Lewis. “They’ve been around for a long time and they don’t change a whole lot, Very interesting [is] that the TB drugs lead the list, especially INH [isoniazid] and pyrazinamide, as well as antibiotics, especially augmentin.”

Nevertheless, activity continues to increase in the DILI field. Looking at PubMed, said Dr. Lewis, there are already over 300 citations involving DILI from January through April of this year, over 1,500 in all of 2014, and over 6,000 from 2010 to 2014. Compared to that, there were around 7,000 in total from 2000 to 2009.

The relationship between dosage and likelihood of liver injury still needs examination, declared Dr. Lewis, citing separate works done by Dr. Hy Zimmerman and Dr. Jack Uetretcht. The former determined that there were certain drugs for which the likelihood of liver injury could be predicted, such as acetaminophen, and those for which such risk was idiosyncratic.

Dr. Uetrecht determined that 10-mg doses were the cutoff at which liver injury became possible. In 2008, work by Lammert et al., published in Hepatology, revealed that doses of 10 mg or less resulted in a 9% risk of DILI, compared with 14.2% for doses of 11-49 mg, and 77% for doses at or above 50 mg. “There are over 200 drugs that have been found to cause DILI, but the top 10 alone account for 50% of all DILI, and the top 25 drugs account for [67%],” said Dr. Lewis. “This means that the other 175 drugs have maybe one case of DILI in the [DILI Network] entire database.”

What this means, concluded Dr. Lewis, is that DILI does not occur often with most drugs, and the ones that cause it are those that are already known.

Dr. Lewis disclosed receiving grant/research support from Ocera Therapeutics, Inc.; consultant relationships with GlaxoSmithKline, Otsuka Pharmaceutical Co. Ltd., Takeda Pharmaceuticals U.S.A. Inc., AstraZeneca, and Lundbeck Inc.; and being a member of the speaking bureau for Gilead Science, Inc.

[email protected]

PHILADELPHIA – The topic of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) was discussed at length by Dr. Zobair M. Younossi, a physician with the Inova Health System of northern Virginia, at the second annual Digestive Diseases: New Advances meeting on Saturday.

Both NAFLD and NASH are becoming increasingly prevalent conditions in the United States, and proper diagnostic and treatment options are therefore becoming more necessary. To that end, Dr. Younossi talked about a number of existing and emerging options that physicians and clinicians can choose from.

“[NAFLD] is a very common disease, its prevalence in the United States is about 20%-25%,” said Dr. Younossi. “When you look at certain individuals who are at-risk, such as those who undergo bariatric surgery, the prevalence goes up to 90%-95%, and diabetics have a prevalence of about 50%-65%.”

When you look at the prevalence of NASH, the progressive form of NAFLD, it goes down to only about 2%-3%; however, said Dr. Younossi, “when you put this in the context of hepatitis C, which has a prevalence of about 1.8%, you see that it’s becoming quite common.”

In this video interview, Dr. Younossi discusses his overview of management options for NAFLD and related conditions, as well as his take on new and emerging options that he feels clinicians should be keeping their eye on.

Dr. Younossi has been a consultant to Gilead, AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Intercept, and Salix.

PHILADELPHIA – The topic of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) was discussed at length by Dr. Zobair M. Younossi, a physician with the Inova Health System of northern Virginia, at the second annual Digestive Diseases: New Advances meeting on Saturday.

Both NAFLD and NASH are becoming increasingly prevalent conditions in the United States, and proper diagnostic and treatment options are therefore becoming more necessary. To that end, Dr. Younossi talked about a number of existing and emerging options that physicians and clinicians can choose from.

“[NAFLD] is a very common disease, its prevalence in the United States is about 20%-25%,” said Dr. Younossi. “When you look at certain individuals who are at-risk, such as those who undergo bariatric surgery, the prevalence goes up to 90%-95%, and diabetics have a prevalence of about 50%-65%.”

When you look at the prevalence of NASH, the progressive form of NAFLD, it goes down to only about 2%-3%; however, said Dr. Younossi, “when you put this in the context of hepatitis C, which has a prevalence of about 1.8%, you see that it’s becoming quite common.”

In this video interview, Dr. Younossi discusses his overview of management options for NAFLD and related conditions, as well as his take on new and emerging options that he feels clinicians should be keeping their eye on.

Dr. Younossi has been a consultant to Gilead, AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Intercept, and Salix.

PHILADELPHIA – The topic of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) was discussed at length by Dr. Zobair M. Younossi, a physician with the Inova Health System of northern Virginia, at the second annual Digestive Diseases: New Advances meeting on Saturday.

Both NAFLD and NASH are becoming increasingly prevalent conditions in the United States, and proper diagnostic and treatment options are therefore becoming more necessary. To that end, Dr. Younossi talked about a number of existing and emerging options that physicians and clinicians can choose from.

“[NAFLD] is a very common disease, its prevalence in the United States is about 20%-25%,” said Dr. Younossi. “When you look at certain individuals who are at-risk, such as those who undergo bariatric surgery, the prevalence goes up to 90%-95%, and diabetics have a prevalence of about 50%-65%.”

When you look at the prevalence of NASH, the progressive form of NAFLD, it goes down to only about 2%-3%; however, said Dr. Younossi, “when you put this in the context of hepatitis C, which has a prevalence of about 1.8%, you see that it’s becoming quite common.”

In this video interview, Dr. Younossi discusses his overview of management options for NAFLD and related conditions, as well as his take on new and emerging options that he feels clinicians should be keeping their eye on.

Dr. Younossi has been a consultant to Gilead, AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Intercept, and Salix.

PHILADELPHIA – The topic of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) was discussed at length by Dr. Zobair M. Younossi, a physician with the Inova Health System of northern Virginia, at the second annual Digestive Diseases: New Advances meeting on Saturday.

Both NAFLD and NASH are becoming increasingly prevalent conditions in the United States, and proper diagnostic and treatment options are therefore becoming more necessary. To that end, Dr. Younossi talked about a number of existing and emerging options that physicians and clinicians can choose from.

“[NAFLD] is a very common disease, its prevalence in the United States is about 20%-25%,” said Dr. Younossi. “When you look at certain individuals who are at-risk, such as those who undergo bariatric surgery, the prevalence goes up to 90%-95%, and diabetics have a prevalence of about 50%-65%.”

When you look at the prevalence of NASH, the progressive form of NAFLD, it goes down to only about 2%-3%; however, said Dr. Younossi, “when you put this in the context of hepatitis C, which has a prevalence of about 1.8%, you see that it’s becoming quite common.”

In this video interview, Dr. Younossi discusses his overview of management options for NAFLD and related conditions, as well as his take on new and emerging options that he feels clinicians should be keeping their eye on.

Dr. Younossi has been a consultant to Gilead, AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Intercept, and Salix.

[email protected]

PHILADELPHIA – The topic of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) was discussed at length by Dr. Zobair M. Younossi, a physician with the Inova Health System of northern Virginia, at the second annual Digestive Diseases: New Advances meeting on Saturday.

Both NAFLD and NASH are becoming increasingly prevalent conditions in the United States, and proper diagnostic and treatment options are therefore becoming more necessary. To that end, Dr. Younossi talked about a number of existing and emerging options that physicians and clinicians can choose from.

“[NAFLD] is a very common disease, its prevalence in the United States is about 20%-25%,” said Dr. Younossi. “When you look at certain individuals who are at-risk, such as those who undergo bariatric surgery, the prevalence goes up to 90%-95%, and diabetics have a prevalence of about 50%-65%.”

When you look at the prevalence of NASH, the progressive form of NAFLD, it goes down to only about 2%-3%; however, said Dr. Younossi, “when you put this in the context of hepatitis C, which has a prevalence of about 1.8%, you see that it’s becoming quite common.”

In this video interview, Dr. Younossi discusses his overview of management options for NAFLD and related conditions, as well as his take on new and emerging options that he feels clinicians should be keeping their eye on.

Dr. Younossi has been a consultant to Gilead, AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Intercept, and Salix.

[email protected]

PHILADELPHIA – The topic of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) was discussed at length by Dr. Zobair M. Younossi, a physician with the Inova Health System of northern Virginia, at the second annual Digestive Diseases: New Advances meeting on Saturday.

Both NAFLD and NASH are becoming increasingly prevalent conditions in the United States, and proper diagnostic and treatment options are therefore becoming more necessary. To that end, Dr. Younossi talked about a number of existing and emerging options that physicians and clinicians can choose from.

“[NAFLD] is a very common disease, its prevalence in the United States is about 20%-25%,” said Dr. Younossi. “When you look at certain individuals who are at-risk, such as those who undergo bariatric surgery, the prevalence goes up to 90%-95%, and diabetics have a prevalence of about 50%-65%.”

When you look at the prevalence of NASH, the progressive form of NAFLD, it goes down to only about 2%-3%; however, said Dr. Younossi, “when you put this in the context of hepatitis C, which has a prevalence of about 1.8%, you see that it’s becoming quite common.”

In this video interview, Dr. Younossi discusses his overview of management options for NAFLD and related conditions, as well as his take on new and emerging options that he feels clinicians should be keeping their eye on.

Dr. Younossi has been a consultant to Gilead, AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Intercept, and Salix.

[email protected]

PHILADELPHIA – The treatment of patients with hepatic encephalopathy is still plagued by confusion, misdiagnosis, and poor treatment, and requires new protocols to improve overall patient care.

“It’s surprisingly difficult to define hepatic encephalopathy [HE],” said Dr. Kevin D. Mullen, from the Metrohealth Medical Center in Cleveland, Ohio, who spoke at the second annual Digestive Diseases: New Advances meeting on Saturday. “It can range from subtle, minimal changes all the way to full-blown coma, but the only way to confirm [HE] is through psychometric testing.”

This inability to properly define HE can lead to problems for patients, Dr. Mullen explained. Many physicians tend to use too much lactulose in HE patients, which can lead to dehydration and hypernatremia, especially in patients in an hepatic coma. Hypernatremia is often treated with furosemide, which can lead to deafness in patients and delay recovery.

Additionally, improper use of rifaximin and metronidazole are common issues that need to be addressed by hepatologists, as well as the beliefs that precipitating factors do not need to be looked at very carefully when diagnosing and treating the condition, as well as the notion that concomitant disease – especially hypothyroidism – rarely, if ever, causes coma.

Management of HE, therefore, should always include identification and treatment of precipitating factors, physicians should rule out other potential causes of encephalopathy, unconscious patients should be given supportive care as soon as possible, and specific additional measures should begin right away based on the precipitating factors, which can also include hypo/hyperglycemia, CNS or systemic sepsis, and post-ictal confusion.

Dr. Mullen also talked about covert hepatic encephalopathy, a relatively new term that describes milder HEs that often are undiagnosed but can still cause severe consequences. Covert HE is often found in patients with cirrhosis, and can lead to cognitive deficiencies in attention, information processing, motor abilities, and can impair social, physical, and job-related interactions.

“The terms ‘subclinical’ and ‘minimal’ keep popping up, but we’re trying very hard to get people to use ‘covert,’” explained Dr. Mullen. “These are patients who have a normal neurological examination [but] subnormal performance in two or more psychometric tests, such as number connection tests A and B, line drawing, serial dotting, and digit symbol.”

Dr. Mullen disclosed being on the speaker’s bureau for Salix Pharmaceuticals, Inc.

[email protected]

PHILADELPHIA – The treatment of patients with hepatic encephalopathy is still plagued by confusion, misdiagnosis, and poor treatment, and requires new protocols to improve overall patient care.

“It’s surprisingly difficult to define hepatic encephalopathy [HE],” said Dr. Kevin D. Mullen, from the Metrohealth Medical Center in Cleveland, Ohio, who spoke at the second annual Digestive Diseases: New Advances meeting on Saturday. “It can range from subtle, minimal changes all the way to full-blown coma, but the only way to confirm [HE] is through psychometric testing.”

This inability to properly define HE can lead to problems for patients, Dr. Mullen explained. Many physicians tend to use too much lactulose in HE patients, which can lead to dehydration and hypernatremia, especially in patients in an hepatic coma. Hypernatremia is often treated with furosemide, which can lead to deafness in patients and delay recovery.

Additionally, improper use of rifaximin and metronidazole are common issues that need to be addressed by hepatologists, as well as the beliefs that precipitating factors do not need to be looked at very carefully when diagnosing and treating the condition, as well as the notion that concomitant disease – especially hypothyroidism – rarely, if ever, causes coma.

Management of HE, therefore, should always include identification and treatment of precipitating factors, physicians should rule out other potential causes of encephalopathy, unconscious patients should be given supportive care as soon as possible, and specific additional measures should begin right away based on the precipitating factors, which can also include hypo/hyperglycemia, CNS or systemic sepsis, and post-ictal confusion.

Dr. Mullen also talked about covert hepatic encephalopathy, a relatively new term that describes milder HEs that often are undiagnosed but can still cause severe consequences. Covert HE is often found in patients with cirrhosis, and can lead to cognitive deficiencies in attention, information processing, motor abilities, and can impair social, physical, and job-related interactions.

“The terms ‘subclinical’ and ‘minimal’ keep popping up, but we’re trying very hard to get people to use ‘covert,’” explained Dr. Mullen. “These are patients who have a normal neurological examination [but] subnormal performance in two or more psychometric tests, such as number connection tests A and B, line drawing, serial dotting, and digit symbol.”

Dr. Mullen disclosed being on the speaker’s bureau for Salix Pharmaceuticals, Inc.

[email protected]

PHILADELPHIA – The treatment of patients with hepatic encephalopathy is still plagued by confusion, misdiagnosis, and poor treatment, and requires new protocols to improve overall patient care.

“It’s surprisingly difficult to define hepatic encephalopathy [HE],” said Dr. Kevin D. Mullen, from the Metrohealth Medical Center in Cleveland, Ohio, who spoke at the second annual Digestive Diseases: New Advances meeting on Saturday. “It can range from subtle, minimal changes all the way to full-blown coma, but the only way to confirm [HE] is through psychometric testing.”

This inability to properly define HE can lead to problems for patients, Dr. Mullen explained. Many physicians tend to use too much lactulose in HE patients, which can lead to dehydration and hypernatremia, especially in patients in an hepatic coma. Hypernatremia is often treated with furosemide, which can lead to deafness in patients and delay recovery.

Additionally, improper use of rifaximin and metronidazole are common issues that need to be addressed by hepatologists, as well as the beliefs that precipitating factors do not need to be looked at very carefully when diagnosing and treating the condition, as well as the notion that concomitant disease – especially hypothyroidism – rarely, if ever, causes coma.

Management of HE, therefore, should always include identification and treatment of precipitating factors, physicians should rule out other potential causes of encephalopathy, unconscious patients should be given supportive care as soon as possible, and specific additional measures should begin right away based on the precipitating factors, which can also include hypo/hyperglycemia, CNS or systemic sepsis, and post-ictal confusion.

Dr. Mullen also talked about covert hepatic encephalopathy, a relatively new term that describes milder HEs that often are undiagnosed but can still cause severe consequences. Covert HE is often found in patients with cirrhosis, and can lead to cognitive deficiencies in attention, information processing, motor abilities, and can impair social, physical, and job-related interactions.

“The terms ‘subclinical’ and ‘minimal’ keep popping up, but we’re trying very hard to get people to use ‘covert,’” explained Dr. Mullen. “These are patients who have a normal neurological examination [but] subnormal performance in two or more psychometric tests, such as number connection tests A and B, line drawing, serial dotting, and digit symbol.”

Dr. Mullen disclosed being on the speaker’s bureau for Salix Pharmaceuticals, Inc.

[email protected]

PHILADELPHIA – The pathophysiology of irritable bowel syndrome (IBS) was the focus of a presentation given by Dr. Anthony J. Lembo at the 2nd annual Digestive Diseases meeting in Philadelphia on Friday.

Specifically, Dr. Lembo discussed the debate about whether diagnosing the condition should focus on a patient’s gut or head; that is, if enhanced perception of a bowel disorder can lead to visceral hypersensitivity and altered motility, which results in a diagnosis of IBS when, in fact, the issue is psychosomatic. Dr. Lembo, a professor at Harvard Medical School and Beth Israel Deaconess Medical Center, explained that there is a growing shift toward diagnosing IBS as a brain-to-gut interaction rather than as something based purely on limited motility. Patients presenting with comorbid conditions such as depression, migraine, anxiety, neuralgia, chronic fatigue or pain, or fibromytosis are all more likely to not only have IBS, but to have more severe symptoms and lower quality of life.

“When I see a patient who has a lot of these symptoms together, I realize that I need to be very aggressive and use a multimodal approach,” said Dr. Lembo. “I talk to their other physicians, and do more of the brain treatment, psychological treatment, CNS drugs, as well as some peripheral ones.”

For these reasons, Dr. Lembo said that the current Rome III criteria for treatment of IBS are not sufficient to be used on their own in diagnosing and treating IBS, saying “IBS is a heterogeneous disorder with both peripheral and central mechanisms” that must be treated as such. In treating the central nervous system, Dr. Lembo discussed 5-HT₃ antagonists, serotonin modulators, antidepressants, and placebos. Peripheral treatments can come in the form of either diets, fiber regimens, antibiotics, GC-C agonists*, 5-HT₃ antagonists, and probiotics/prebiotics, although efficacies and approvals vary.

Dr. Lembo disclosed numerous potential conflicts of interest: consultantships with Ironwood/Forest, Astra-Zeneca, Furiex, Salix, Prometheus, Astellas, and GlaxoSmithKlinel; honoraria from Ironwood/Forest, Astra-Zeneca, Furiex, Salix, Prometheus, and GlaxoSmithKline; and research grants/contracts from Prometheus and Furiex.

*Content was corrected on 7/1/2015.

[email protected]

PHILADELPHIA – The pathophysiology of irritable bowel syndrome (IBS) was the focus of a presentation given by Dr. Anthony J. Lembo at the 2nd annual Digestive Diseases meeting in Philadelphia on Friday.

Specifically, Dr. Lembo discussed the debate about whether diagnosing the condition should focus on a patient’s gut or head; that is, if enhanced perception of a bowel disorder can lead to visceral hypersensitivity and altered motility, which results in a diagnosis of IBS when, in fact, the issue is psychosomatic. Dr. Lembo, a professor at Harvard Medical School and Beth Israel Deaconess Medical Center, explained that there is a growing shift toward diagnosing IBS as a brain-to-gut interaction rather than as something based purely on limited motility. Patients presenting with comorbid conditions such as depression, migraine, anxiety, neuralgia, chronic fatigue or pain, or fibromytosis are all more likely to not only have IBS, but to have more severe symptoms and lower quality of life.

“When I see a patient who has a lot of these symptoms together, I realize that I need to be very aggressive and use a multimodal approach,” said Dr. Lembo. “I talk to their other physicians, and do more of the brain treatment, psychological treatment, CNS drugs, as well as some peripheral ones.”

For these reasons, Dr. Lembo said that the current Rome III criteria for treatment of IBS are not sufficient to be used on their own in diagnosing and treating IBS, saying “IBS is a heterogeneous disorder with both peripheral and central mechanisms” that must be treated as such. In treating the central nervous system, Dr. Lembo discussed 5-HT₃ antagonists, serotonin modulators, antidepressants, and placebos. Peripheral treatments can come in the form of either diets, fiber regimens, antibiotics, GC-C agonists*, 5-HT₃ antagonists, and probiotics/prebiotics, although efficacies and approvals vary.

Dr. Lembo disclosed numerous potential conflicts of interest: consultantships with Ironwood/Forest, Astra-Zeneca, Furiex, Salix, Prometheus, Astellas, and GlaxoSmithKlinel; honoraria from Ironwood/Forest, Astra-Zeneca, Furiex, Salix, Prometheus, and GlaxoSmithKline; and research grants/contracts from Prometheus and Furiex.

*Content was corrected on 7/1/2015.

[email protected]

PHILADELPHIA – The pathophysiology of irritable bowel syndrome (IBS) was the focus of a presentation given by Dr. Anthony J. Lembo at the 2nd annual Digestive Diseases meeting in Philadelphia on Friday.

Specifically, Dr. Lembo discussed the debate about whether diagnosing the condition should focus on a patient’s gut or head; that is, if enhanced perception of a bowel disorder can lead to visceral hypersensitivity and altered motility, which results in a diagnosis of IBS when, in fact, the issue is psychosomatic. Dr. Lembo, a professor at Harvard Medical School and Beth Israel Deaconess Medical Center, explained that there is a growing shift toward diagnosing IBS as a brain-to-gut interaction rather than as something based purely on limited motility. Patients presenting with comorbid conditions such as depression, migraine, anxiety, neuralgia, chronic fatigue or pain, or fibromytosis are all more likely to not only have IBS, but to have more severe symptoms and lower quality of life.

“When I see a patient who has a lot of these symptoms together, I realize that I need to be very aggressive and use a multimodal approach,” said Dr. Lembo. “I talk to their other physicians, and do more of the brain treatment, psychological treatment, CNS drugs, as well as some peripheral ones.”

For these reasons, Dr. Lembo said that the current Rome III criteria for treatment of IBS are not sufficient to be used on their own in diagnosing and treating IBS, saying “IBS is a heterogeneous disorder with both peripheral and central mechanisms” that must be treated as such. In treating the central nervous system, Dr. Lembo discussed 5-HT₃ antagonists, serotonin modulators, antidepressants, and placebos. Peripheral treatments can come in the form of either diets, fiber regimens, antibiotics, GC-C agonists*, 5-HT₃ antagonists, and probiotics/prebiotics, although efficacies and approvals vary.

Dr. Lembo disclosed numerous potential conflicts of interest: consultantships with Ironwood/Forest, Astra-Zeneca, Furiex, Salix, Prometheus, Astellas, and GlaxoSmithKlinel; honoraria from Ironwood/Forest, Astra-Zeneca, Furiex, Salix, Prometheus, and GlaxoSmithKline; and research grants/contracts from Prometheus and Furiex.

*Content was corrected on 7/1/2015.

[email protected]

NASHVILLE – Saroglitazar, currently approved for use in India only, is effective and safe for treating diabetic dyslipidemia and has been shown to be a potent agent for managing levels of triglycerides, cholesterol, glucose, and hemoglobin A_1c.

This is according to a postmarketing surveillance study presented by Dr. Shashank Joshi, whose endocrinology clinic in Mumbai was involved in a 9-month trial to test the safety and efficacy of once-daily 4-mg doses of Saroglitazar on a population with diabetic dyslipidemia. Saroglitazar, manufactured by Zydus, is the first dual-PPAR (peroxisome proliferator-activated receptor) alpha and gamma agonist available commercially anywhere in the world, and has been approved only in India and on the market in that country for 20 months.

“[Saroglitazar] is fundamentally not structurally similar to a glitazone, [nor] to a fibrate, and it’s also not structurally similar to other glitazars, which have been investigated,” explained Dr. Joshi, who added that all phase III studies of saroglitazar have been published. “We [also] know diabetic dyslipidemia is very prevalent in the Indian population, shown predominantly [by] low HDL, high triglycerides, and high LDL.”

A total of 787 diabetic dyslipidemia patients were included in the study, all of whom were evaluated for lipid and glycemic parameters at baseline. The mean age of subjects was 53 years, mean weight was 73.9 kg, and 507 subjects (64.4%) were male. All subjects underwent follow-ups at 3, 6, and 9 months after baseline.

Mean triglyceride, LDL cholesterol, non-HDL cholesterol, and total cholesterol levels all showed significant reductions: Triglycerides dropped 43.8% from 297.9 mg/dL to 156.1 mg/dL, LDL levels dropped 18.5% from 132.5 mg/dL to 100.5 mg/dL, non-HDL levels dropped 29.7% from 199 mg/dL to 131.9 mg/dL, and total cholesterol levels dropped 23.1% from 239.9 mg/dL to 176.6 mg/dL (P <.001 for all).

Significant reductions were also seen in HbA_1clevels (8.5% to 7%), fasting glucose levels (171.6 mg/dL to 116.4 mg/dL), and postprandial glucose levels (244.6 mg/dL to 149.7 mg/dL) (P <.001 for all). Furthermore, HDL levels improved by 12.7%, over the 9-month period, going from 41 mg/dL to 44.5 mg/dL.

Seven hundred and twenty-two subjects (91.7%) were on an antidiabetic medication at baseline, the most common of which were metformin (73.7%), sulfonylureas (58.3%), dipeptidyl peptidase–4 inhibitors (26.2%), and insulin (17.4%). More than half of these patients (365; 50.6%) were on dual therapy, 195 (27%) were on triple therapy, 135 (18.7%) were on monotherapy, and 27 (3.7%) of these subjects were taking more than three drugs at baseline. Of the 787 in the total population, 395 (50.2%) were on statins, the most common of which was atorvastatin (71%).

“[Saroglitazar] was well tolerated over a long term of 9 months, with no weight gain and edema, and no serious adverse events reported,” said Dr. Joshi, who also acknowledged potential limitations of the trial because of its being an ongoing, prospective study.

Dr. Joshi disclosed relationships with Zydus, maker of saroglitazar, and numerous other pharmaceutical companies.

[email protected]

NASHVILLE – Saroglitazar, currently approved for use in India only, is effective and safe for treating diabetic dyslipidemia and has been shown to be a potent agent for managing levels of triglycerides, cholesterol, glucose, and hemoglobin A_1c.

This is according to a postmarketing surveillance study presented by Dr. Shashank Joshi, whose endocrinology clinic in Mumbai was involved in a 9-month trial to test the safety and efficacy of once-daily 4-mg doses of Saroglitazar on a population with diabetic dyslipidemia. Saroglitazar, manufactured by Zydus, is the first dual-PPAR (peroxisome proliferator-activated receptor) alpha and gamma agonist available commercially anywhere in the world, and has been approved only in India and on the market in that country for 20 months.

“[Saroglitazar] is fundamentally not structurally similar to a glitazone, [nor] to a fibrate, and it’s also not structurally similar to other glitazars, which have been investigated,” explained Dr. Joshi, who added that all phase III studies of saroglitazar have been published. “We [also] know diabetic dyslipidemia is very prevalent in the Indian population, shown predominantly [by] low HDL, high triglycerides, and high LDL.”

A total of 787 diabetic dyslipidemia patients were included in the study, all of whom were evaluated for lipid and glycemic parameters at baseline. The mean age of subjects was 53 years, mean weight was 73.9 kg, and 507 subjects (64.4%) were male. All subjects underwent follow-ups at 3, 6, and 9 months after baseline.

Mean triglyceride, LDL cholesterol, non-HDL cholesterol, and total cholesterol levels all showed significant reductions: Triglycerides dropped 43.8% from 297.9 mg/dL to 156.1 mg/dL, LDL levels dropped 18.5% from 132.5 mg/dL to 100.5 mg/dL, non-HDL levels dropped 29.7% from 199 mg/dL to 131.9 mg/dL, and total cholesterol levels dropped 23.1% from 239.9 mg/dL to 176.6 mg/dL (P <.001 for all).

Significant reductions were also seen in HbA_1clevels (8.5% to 7%), fasting glucose levels (171.6 mg/dL to 116.4 mg/dL), and postprandial glucose levels (244.6 mg/dL to 149.7 mg/dL) (P <.001 for all). Furthermore, HDL levels improved by 12.7%, over the 9-month period, going from 41 mg/dL to 44.5 mg/dL.

Seven hundred and twenty-two subjects (91.7%) were on an antidiabetic medication at baseline, the most common of which were metformin (73.7%), sulfonylureas (58.3%), dipeptidyl peptidase–4 inhibitors (26.2%), and insulin (17.4%). More than half of these patients (365; 50.6%) were on dual therapy, 195 (27%) were on triple therapy, 135 (18.7%) were on monotherapy, and 27 (3.7%) of these subjects were taking more than three drugs at baseline. Of the 787 in the total population, 395 (50.2%) were on statins, the most common of which was atorvastatin (71%).

“[Saroglitazar] was well tolerated over a long term of 9 months, with no weight gain and edema, and no serious adverse events reported,” said Dr. Joshi, who also acknowledged potential limitations of the trial because of its being an ongoing, prospective study.

Dr. Joshi disclosed relationships with Zydus, maker of saroglitazar, and numerous other pharmaceutical companies.

[email protected]

NASHVILLE – Saroglitazar, currently approved for use in India only, is effective and safe for treating diabetic dyslipidemia and has been shown to be a potent agent for managing levels of triglycerides, cholesterol, glucose, and hemoglobin A_1c.

This is according to a postmarketing surveillance study presented by Dr. Shashank Joshi, whose endocrinology clinic in Mumbai was involved in a 9-month trial to test the safety and efficacy of once-daily 4-mg doses of Saroglitazar on a population with diabetic dyslipidemia. Saroglitazar, manufactured by Zydus, is the first dual-PPAR (peroxisome proliferator-activated receptor) alpha and gamma agonist available commercially anywhere in the world, and has been approved only in India and on the market in that country for 20 months.

“[Saroglitazar] is fundamentally not structurally similar to a glitazone, [nor] to a fibrate, and it’s also not structurally similar to other glitazars, which have been investigated,” explained Dr. Joshi, who added that all phase III studies of saroglitazar have been published. “We [also] know diabetic dyslipidemia is very prevalent in the Indian population, shown predominantly [by] low HDL, high triglycerides, and high LDL.”

A total of 787 diabetic dyslipidemia patients were included in the study, all of whom were evaluated for lipid and glycemic parameters at baseline. The mean age of subjects was 53 years, mean weight was 73.9 kg, and 507 subjects (64.4%) were male. All subjects underwent follow-ups at 3, 6, and 9 months after baseline.

Mean triglyceride, LDL cholesterol, non-HDL cholesterol, and total cholesterol levels all showed significant reductions: Triglycerides dropped 43.8% from 297.9 mg/dL to 156.1 mg/dL, LDL levels dropped 18.5% from 132.5 mg/dL to 100.5 mg/dL, non-HDL levels dropped 29.7% from 199 mg/dL to 131.9 mg/dL, and total cholesterol levels dropped 23.1% from 239.9 mg/dL to 176.6 mg/dL (P <.001 for all).

Significant reductions were also seen in HbA_1clevels (8.5% to 7%), fasting glucose levels (171.6 mg/dL to 116.4 mg/dL), and postprandial glucose levels (244.6 mg/dL to 149.7 mg/dL) (P <.001 for all). Furthermore, HDL levels improved by 12.7%, over the 9-month period, going from 41 mg/dL to 44.5 mg/dL.

Seven hundred and twenty-two subjects (91.7%) were on an antidiabetic medication at baseline, the most common of which were metformin (73.7%), sulfonylureas (58.3%), dipeptidyl peptidase–4 inhibitors (26.2%), and insulin (17.4%). More than half of these patients (365; 50.6%) were on dual therapy, 195 (27%) were on triple therapy, 135 (18.7%) were on monotherapy, and 27 (3.7%) of these subjects were taking more than three drugs at baseline. Of the 787 in the total population, 395 (50.2%) were on statins, the most common of which was atorvastatin (71%).

“[Saroglitazar] was well tolerated over a long term of 9 months, with no weight gain and edema, and no serious adverse events reported,” said Dr. Joshi, who also acknowledged potential limitations of the trial because of its being an ongoing, prospective study.

Dr. Joshi disclosed relationships with Zydus, maker of saroglitazar, and numerous other pharmaceutical companies.

[email protected]