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Telaprevir Improved Outcomes for Hep C Patients Who Failed Prior Therapy
CHICAGO – Adding the protease inhibitor telaprevir to the standard combination therapy of pegylated interferon alfa-2a and ribavirin significantly improved outcomes in three categories of genotype 1 hepatitis C patients who had failed standard treatment, according to final results from the phase III REALIZE trial.
Approximately 60% of genotype 1 hepatitis C patients treated with standard therapy do not respond, said Dr. Zobair M. Younossi of Inova Fairfax Hospital in Falls Church, Va. "Re-treating these patients will be very difficult if you want to treat them with the currently available double-combination therapy," said Dr. Younossi, who presented the study findings in a press conference at the annual Digestive Disease Week.
The researchers, led by Dr. Paul Pockros of the Scripps Translational Science Institute in La Jolla, Calif., conducted an international, multicenter, double-blind, randomized placebo-controlled trial – the REALIZE trial – to assess the safety and tolerability of adding 750 mg of telaprevir every 8 hours to the standard therapy of 180 mcg/week of pegylated interferon alfa-2a and 1000-1200 mg/day of ribavirin. The control group received the standard therapy plus a placebo.
The treatment arms were as follows: telaprevir plus standard therapy for 12 weeks followed by standard therapy for 36 weeks; standard therapy for 4 weeks followed by telaprevir plus standard therapy for 12 weeks and then standard therapy for 32 weeks; and standard therapy for 48 weeks.
Approximately 70% of the 662 treated patients were male, and 93% were white. About one-quarter (26%) had cirrhosis, and 89% had a baseline HCV RNA level of at least 800,000 IU/mL. They were divided into three groups: those who had relapsed after standard treatment, those who had a partial response to standard treatment, and those who had no response to standard treatment.
Among the prior relapsers, the response rate in the telaprevir patients was 83%-88%, compared with 23% in the placebo group. Among the prior partial responders, the response rate in the telaprevir patients ranged from 54% to 59%, compared with 23% of the placebo patients. And among the prior nonresponders, the response rate was 29% to 33% in the telaprevir group and 5% in the placebo group. The differences between telaprevir and placebo were significant in all three patient categories – prior partial responders, prior nonresponders, and prior relapsers.
The main goal of the study was to assess whether telaprevir together with standard therapy had superior efficacy for prior relapsers and prior nonresponders, compared with standard therapy alone.
"Another important part of the study was that the lead-in phase did not add to the efficacy and the sustained virologic response in these patients," Dr. Younossi noted.
The safety and tolerability data for telaprevir were similar to results from previous studies, Dr. Younossi said. The most frequently reported adverse events included fatigue, pruritus, rash, nausea, flulike symptoms, anemia, and diarrhea. Rash (4%) and anemia (3%) were the most common reasons given for treatment discontinuation.
"We are on the verge of the next wave of treatment for hepatitis C," said the moderator of the press conference, Dr. Adrian M. Di Bisceglie, codirector of the liver center and chief of hepatology, St. Louis University. Both telaprevir and boceprevir (which was not evaluated in the REALIZE trial) are protease inhibitors; they are direct-acting antivirals that have been tested in phase III trials with pegylated interferon and ribavirin, he said.
On April 27, the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration unanimously voted to recommend approval of boceprevir and, on April 28, unanimously voted to recommend approval of telaprevir, both for use in combination with pegylated interferon and ribavirin as a treatment for genotype 1 chronic hepatitis C. At press time, neither drug had been approved, but approval was considered imminent for both drugs.
Dr. Younossi has served on advisory committees or review boards for multiple pharmaceutical companies, including study sponsor Vertex Pharmaceuticals.
CHICAGO – Adding the protease inhibitor telaprevir to the standard combination therapy of pegylated interferon alfa-2a and ribavirin significantly improved outcomes in three categories of genotype 1 hepatitis C patients who had failed standard treatment, according to final results from the phase III REALIZE trial.
Approximately 60% of genotype 1 hepatitis C patients treated with standard therapy do not respond, said Dr. Zobair M. Younossi of Inova Fairfax Hospital in Falls Church, Va. "Re-treating these patients will be very difficult if you want to treat them with the currently available double-combination therapy," said Dr. Younossi, who presented the study findings in a press conference at the annual Digestive Disease Week.
The researchers, led by Dr. Paul Pockros of the Scripps Translational Science Institute in La Jolla, Calif., conducted an international, multicenter, double-blind, randomized placebo-controlled trial – the REALIZE trial – to assess the safety and tolerability of adding 750 mg of telaprevir every 8 hours to the standard therapy of 180 mcg/week of pegylated interferon alfa-2a and 1000-1200 mg/day of ribavirin. The control group received the standard therapy plus a placebo.
The treatment arms were as follows: telaprevir plus standard therapy for 12 weeks followed by standard therapy for 36 weeks; standard therapy for 4 weeks followed by telaprevir plus standard therapy for 12 weeks and then standard therapy for 32 weeks; and standard therapy for 48 weeks.
Approximately 70% of the 662 treated patients were male, and 93% were white. About one-quarter (26%) had cirrhosis, and 89% had a baseline HCV RNA level of at least 800,000 IU/mL. They were divided into three groups: those who had relapsed after standard treatment, those who had a partial response to standard treatment, and those who had no response to standard treatment.
Among the prior relapsers, the response rate in the telaprevir patients was 83%-88%, compared with 23% in the placebo group. Among the prior partial responders, the response rate in the telaprevir patients ranged from 54% to 59%, compared with 23% of the placebo patients. And among the prior nonresponders, the response rate was 29% to 33% in the telaprevir group and 5% in the placebo group. The differences between telaprevir and placebo were significant in all three patient categories – prior partial responders, prior nonresponders, and prior relapsers.
The main goal of the study was to assess whether telaprevir together with standard therapy had superior efficacy for prior relapsers and prior nonresponders, compared with standard therapy alone.
"Another important part of the study was that the lead-in phase did not add to the efficacy and the sustained virologic response in these patients," Dr. Younossi noted.
The safety and tolerability data for telaprevir were similar to results from previous studies, Dr. Younossi said. The most frequently reported adverse events included fatigue, pruritus, rash, nausea, flulike symptoms, anemia, and diarrhea. Rash (4%) and anemia (3%) were the most common reasons given for treatment discontinuation.
"We are on the verge of the next wave of treatment for hepatitis C," said the moderator of the press conference, Dr. Adrian M. Di Bisceglie, codirector of the liver center and chief of hepatology, St. Louis University. Both telaprevir and boceprevir (which was not evaluated in the REALIZE trial) are protease inhibitors; they are direct-acting antivirals that have been tested in phase III trials with pegylated interferon and ribavirin, he said.
On April 27, the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration unanimously voted to recommend approval of boceprevir and, on April 28, unanimously voted to recommend approval of telaprevir, both for use in combination with pegylated interferon and ribavirin as a treatment for genotype 1 chronic hepatitis C. At press time, neither drug had been approved, but approval was considered imminent for both drugs.
Dr. Younossi has served on advisory committees or review boards for multiple pharmaceutical companies, including study sponsor Vertex Pharmaceuticals.
CHICAGO – Adding the protease inhibitor telaprevir to the standard combination therapy of pegylated interferon alfa-2a and ribavirin significantly improved outcomes in three categories of genotype 1 hepatitis C patients who had failed standard treatment, according to final results from the phase III REALIZE trial.
Approximately 60% of genotype 1 hepatitis C patients treated with standard therapy do not respond, said Dr. Zobair M. Younossi of Inova Fairfax Hospital in Falls Church, Va. "Re-treating these patients will be very difficult if you want to treat them with the currently available double-combination therapy," said Dr. Younossi, who presented the study findings in a press conference at the annual Digestive Disease Week.
The researchers, led by Dr. Paul Pockros of the Scripps Translational Science Institute in La Jolla, Calif., conducted an international, multicenter, double-blind, randomized placebo-controlled trial – the REALIZE trial – to assess the safety and tolerability of adding 750 mg of telaprevir every 8 hours to the standard therapy of 180 mcg/week of pegylated interferon alfa-2a and 1000-1200 mg/day of ribavirin. The control group received the standard therapy plus a placebo.
The treatment arms were as follows: telaprevir plus standard therapy for 12 weeks followed by standard therapy for 36 weeks; standard therapy for 4 weeks followed by telaprevir plus standard therapy for 12 weeks and then standard therapy for 32 weeks; and standard therapy for 48 weeks.
Approximately 70% of the 662 treated patients were male, and 93% were white. About one-quarter (26%) had cirrhosis, and 89% had a baseline HCV RNA level of at least 800,000 IU/mL. They were divided into three groups: those who had relapsed after standard treatment, those who had a partial response to standard treatment, and those who had no response to standard treatment.
Among the prior relapsers, the response rate in the telaprevir patients was 83%-88%, compared with 23% in the placebo group. Among the prior partial responders, the response rate in the telaprevir patients ranged from 54% to 59%, compared with 23% of the placebo patients. And among the prior nonresponders, the response rate was 29% to 33% in the telaprevir group and 5% in the placebo group. The differences between telaprevir and placebo were significant in all three patient categories – prior partial responders, prior nonresponders, and prior relapsers.
The main goal of the study was to assess whether telaprevir together with standard therapy had superior efficacy for prior relapsers and prior nonresponders, compared with standard therapy alone.
"Another important part of the study was that the lead-in phase did not add to the efficacy and the sustained virologic response in these patients," Dr. Younossi noted.
The safety and tolerability data for telaprevir were similar to results from previous studies, Dr. Younossi said. The most frequently reported adverse events included fatigue, pruritus, rash, nausea, flulike symptoms, anemia, and diarrhea. Rash (4%) and anemia (3%) were the most common reasons given for treatment discontinuation.
"We are on the verge of the next wave of treatment for hepatitis C," said the moderator of the press conference, Dr. Adrian M. Di Bisceglie, codirector of the liver center and chief of hepatology, St. Louis University. Both telaprevir and boceprevir (which was not evaluated in the REALIZE trial) are protease inhibitors; they are direct-acting antivirals that have been tested in phase III trials with pegylated interferon and ribavirin, he said.
On April 27, the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration unanimously voted to recommend approval of boceprevir and, on April 28, unanimously voted to recommend approval of telaprevir, both for use in combination with pegylated interferon and ribavirin as a treatment for genotype 1 chronic hepatitis C. At press time, neither drug had been approved, but approval was considered imminent for both drugs.
Dr. Younossi has served on advisory committees or review boards for multiple pharmaceutical companies, including study sponsor Vertex Pharmaceuticals.
FROM THE ANNUAL DIGESTIVE DISEASE WEEK
Major Finding: Among the prior relapsers, the response
rate in the telaprevir patients was 83%-88%, compared with 23% in the placebo
group. Among the prior partial responders, the response rate in the telaprevir
patients ranged from 54% to 59%, compared with 23% of the placebo patients.
Data Source: An international, multicenter,
double-blind, randomized placebo-controlled trial involving 662 patients.
Disclosures: Dr. Younossi has served on advisory committees
or review boards for multiple pharmaceutical companies, including study sponsor
Vertex Pharmaceuticals.
Study: Mortality After Bariatric Surgery Not Higher for Elderly
CHICAGO - Older patients undergoing bariatric surgery had longer hospital stays, but no increased risk of death or major adverse events at 30 days, according to a study of more than 48,000 adults. The findings were presented at the annual Digestive Disease Week on May 9.
Patient age older than 65 years is not a contraindication to bariatric surgery, said Dr. Robert B. Dorman in a press conference in advance of the meeting. Previous studies of bariatric surgery in older adults have been limited to Medicare patients and have not included laparoscopic procedures, he noted.
In this multihospital study, Dr. Dorman of the University of Minnesota, Minneapolis, and his colleagues analyzed data from 48,378 adults with a body mass index of 35 kg/m2 or higher who underwent bariatric surgery between 2005 and 2009. The patients were part of the American College of Surgeons National Surgical Quality Improvement Program.
The types of surgery included open and laparoscopic Roux-en-Y gastric bypass, open duodenal switch, laparoscopic adjustable gastric banding, and vertical banded gastroplasty.
The percentage of bariatric surgery patients aged 65 years or older increased from 1.9% in 2005 to 4.8% in 2009, a significant change. Among all patients, a total of 72 deaths occurred during the study period, and 8 of these occurred in patients aged 65 years or older.
The 30-day mortality did not differ significantly by age group and was under 1% for all age ranges. Specifically, for patients aged 35-49 years, 50-64 years, and 65 years and older mortality was 0.12%, 0.21%, and 0.40%, respectively. A multivariate analysis showed a trend for advancing age as a predictor of mortality, but this was not statistically significant, the researchers noted.
However, age of 65 years or older was a significant predictor of prolonged length of stay for both open and laparoscopic procedures. In addition, older age alone was not a significant predictor of major adverse events for either procedure type. The significant predictors of major adverse events included BMI of 55 or higher, cardiac comorbidities, severe ASA [American Society of Anesthesiologists] score, albumin levels less than 3 g/dL, and creatinine levels greater than 1.5 mg/dL.
“Once corroborated, these results [will] provide important information to patients, surgeons, hospitals, and payers prior to performing bariatric surgery in older persons with obesity,” Dr. Dorman said.
However, “we are certainly not giving the green light for bariatric surgeons to operate on these patients without determining their risk on an individual basis,” he added.
Dr. Dorman had no financial conflicts to disclos
CHICAGO - Older patients undergoing bariatric surgery had longer hospital stays, but no increased risk of death or major adverse events at 30 days, according to a study of more than 48,000 adults. The findings were presented at the annual Digestive Disease Week on May 9.
Patient age older than 65 years is not a contraindication to bariatric surgery, said Dr. Robert B. Dorman in a press conference in advance of the meeting. Previous studies of bariatric surgery in older adults have been limited to Medicare patients and have not included laparoscopic procedures, he noted.
In this multihospital study, Dr. Dorman of the University of Minnesota, Minneapolis, and his colleagues analyzed data from 48,378 adults with a body mass index of 35 kg/m2 or higher who underwent bariatric surgery between 2005 and 2009. The patients were part of the American College of Surgeons National Surgical Quality Improvement Program.
The types of surgery included open and laparoscopic Roux-en-Y gastric bypass, open duodenal switch, laparoscopic adjustable gastric banding, and vertical banded gastroplasty.
The percentage of bariatric surgery patients aged 65 years or older increased from 1.9% in 2005 to 4.8% in 2009, a significant change. Among all patients, a total of 72 deaths occurred during the study period, and 8 of these occurred in patients aged 65 years or older.
The 30-day mortality did not differ significantly by age group and was under 1% for all age ranges. Specifically, for patients aged 35-49 years, 50-64 years, and 65 years and older mortality was 0.12%, 0.21%, and 0.40%, respectively. A multivariate analysis showed a trend for advancing age as a predictor of mortality, but this was not statistically significant, the researchers noted.
However, age of 65 years or older was a significant predictor of prolonged length of stay for both open and laparoscopic procedures. In addition, older age alone was not a significant predictor of major adverse events for either procedure type. The significant predictors of major adverse events included BMI of 55 or higher, cardiac comorbidities, severe ASA [American Society of Anesthesiologists] score, albumin levels less than 3 g/dL, and creatinine levels greater than 1.5 mg/dL.
“Once corroborated, these results [will] provide important information to patients, surgeons, hospitals, and payers prior to performing bariatric surgery in older persons with obesity,” Dr. Dorman said.
However, “we are certainly not giving the green light for bariatric surgeons to operate on these patients without determining their risk on an individual basis,” he added.
Dr. Dorman had no financial conflicts to disclos
CHICAGO - Older patients undergoing bariatric surgery had longer hospital stays, but no increased risk of death or major adverse events at 30 days, according to a study of more than 48,000 adults. The findings were presented at the annual Digestive Disease Week on May 9.
Patient age older than 65 years is not a contraindication to bariatric surgery, said Dr. Robert B. Dorman in a press conference in advance of the meeting. Previous studies of bariatric surgery in older adults have been limited to Medicare patients and have not included laparoscopic procedures, he noted.
In this multihospital study, Dr. Dorman of the University of Minnesota, Minneapolis, and his colleagues analyzed data from 48,378 adults with a body mass index of 35 kg/m2 or higher who underwent bariatric surgery between 2005 and 2009. The patients were part of the American College of Surgeons National Surgical Quality Improvement Program.
The types of surgery included open and laparoscopic Roux-en-Y gastric bypass, open duodenal switch, laparoscopic adjustable gastric banding, and vertical banded gastroplasty.
The percentage of bariatric surgery patients aged 65 years or older increased from 1.9% in 2005 to 4.8% in 2009, a significant change. Among all patients, a total of 72 deaths occurred during the study period, and 8 of these occurred in patients aged 65 years or older.
The 30-day mortality did not differ significantly by age group and was under 1% for all age ranges. Specifically, for patients aged 35-49 years, 50-64 years, and 65 years and older mortality was 0.12%, 0.21%, and 0.40%, respectively. A multivariate analysis showed a trend for advancing age as a predictor of mortality, but this was not statistically significant, the researchers noted.
However, age of 65 years or older was a significant predictor of prolonged length of stay for both open and laparoscopic procedures. In addition, older age alone was not a significant predictor of major adverse events for either procedure type. The significant predictors of major adverse events included BMI of 55 or higher, cardiac comorbidities, severe ASA [American Society of Anesthesiologists] score, albumin levels less than 3 g/dL, and creatinine levels greater than 1.5 mg/dL.
“Once corroborated, these results [will] provide important information to patients, surgeons, hospitals, and payers prior to performing bariatric surgery in older persons with obesity,” Dr. Dorman said.
However, “we are certainly not giving the green light for bariatric surgeons to operate on these patients without determining their risk on an individual basis,” he added.
Dr. Dorman had no financial conflicts to disclos
FROM THE ANNUAL DIGESTIVE DISEASE WEEK
Major Finding: The 30-day mortality did not differ significantly by age group and was under 1% for all age ranges.
Data Source: A multihospital study of 48,378 adults with a
body mass index of 35 kg/m2 or higher who underwent bariatric surgery during 2005 and 2009.
Disclosures: Dr. Dorman had no financial conflicts to disclose.
Age-Based Hep C Screening May Work Better Than Risk-Based Screening
CHICAGO - A targeted, age-based screening program would result in 59,000 fewer deaths associated with hepatitis C and advanced liver disease, compared with the current risk-based screening program, based on statistical modeling.
Under current U.S. screening practices, “people with no risk factors might not get screened,” Dr. Zobair Younossi of the Inova Health System in Fairfax, Va., said during a press conference in advance of the meetingannual Digestive Disease Week. The results were presented at the annual Digestive Disease Week meeting on May 8.
Individuals with hepatitis C may not show symptoms until decades after they have been infected, he noted. Recent studies have shown that the prevalence of hepatitis C virus (HCV) infection among the “baby boomer plus” population (people born in 1946-1970) in the United States may be higher than expected. “A screening strategy based on age, rather than risk factors, could have a significant impact” on the disease, he said.
Dr. Younossi and colleagues used a Markov model of the natural history of the infection and its complications. They applied the model to a population of approximately 102 million individuals who were eligible for screening, and found that the birth cohort screening (BCS) strategy would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer cases of advanced liver disease, compared with the current risk-based screening (RBS) strategy.
The investigators designed a mathematical model using a birth cohort of individuals who were born in the United States in 1946-1970. They estimated the current hepatitis C status and stage of disease progression using a run-in period from 1964 to 2010, as well as using age- and sex-based rates of infection, progression, and spontaneous clearance. BCS involved the assumption that 100% of the cohort would be screened within the first 5 years, starting in 2010.
The model suggested that BCS would cost approximately $25,000 for each additional quality-adjusted year of life gained. BCS would cost more overall than RBS ($45.1 billion vs. 32.0 billion), but BCS would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion), Dr. Younossi said. The up-front investment could be worthwhile in terms of reducing long-term medical costs, he said.
“There are better hepatitis C treatments in development that could increase the benefits of screening,” Dr. Younossi said. Effective screening for hepatitis C now may reduce future costs to Medicare, he added.
I have checked the following facts in my story: (Please initial each.)
The study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on advisory committees or review panels for multiple pharmaceutical companies, including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec.
*This story has been updated and new information has been added.
CHICAGO - A targeted, age-based screening program would result in 59,000 fewer deaths associated with hepatitis C and advanced liver disease, compared with the current risk-based screening program, based on statistical modeling.
Under current U.S. screening practices, “people with no risk factors might not get screened,” Dr. Zobair Younossi of the Inova Health System in Fairfax, Va., said during a press conference in advance of the meetingannual Digestive Disease Week. The results were presented at the annual Digestive Disease Week meeting on May 8.
Individuals with hepatitis C may not show symptoms until decades after they have been infected, he noted. Recent studies have shown that the prevalence of hepatitis C virus (HCV) infection among the “baby boomer plus” population (people born in 1946-1970) in the United States may be higher than expected. “A screening strategy based on age, rather than risk factors, could have a significant impact” on the disease, he said.
Dr. Younossi and colleagues used a Markov model of the natural history of the infection and its complications. They applied the model to a population of approximately 102 million individuals who were eligible for screening, and found that the birth cohort screening (BCS) strategy would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer cases of advanced liver disease, compared with the current risk-based screening (RBS) strategy.
The investigators designed a mathematical model using a birth cohort of individuals who were born in the United States in 1946-1970. They estimated the current hepatitis C status and stage of disease progression using a run-in period from 1964 to 2010, as well as using age- and sex-based rates of infection, progression, and spontaneous clearance. BCS involved the assumption that 100% of the cohort would be screened within the first 5 years, starting in 2010.
The model suggested that BCS would cost approximately $25,000 for each additional quality-adjusted year of life gained. BCS would cost more overall than RBS ($45.1 billion vs. 32.0 billion), but BCS would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion), Dr. Younossi said. The up-front investment could be worthwhile in terms of reducing long-term medical costs, he said.
“There are better hepatitis C treatments in development that could increase the benefits of screening,” Dr. Younossi said. Effective screening for hepatitis C now may reduce future costs to Medicare, he added.
I have checked the following facts in my story: (Please initial each.)
The study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on advisory committees or review panels for multiple pharmaceutical companies, including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec.
*This story has been updated and new information has been added.
CHICAGO - A targeted, age-based screening program would result in 59,000 fewer deaths associated with hepatitis C and advanced liver disease, compared with the current risk-based screening program, based on statistical modeling.
Under current U.S. screening practices, “people with no risk factors might not get screened,” Dr. Zobair Younossi of the Inova Health System in Fairfax, Va., said during a press conference in advance of the meetingannual Digestive Disease Week. The results were presented at the annual Digestive Disease Week meeting on May 8.
Individuals with hepatitis C may not show symptoms until decades after they have been infected, he noted. Recent studies have shown that the prevalence of hepatitis C virus (HCV) infection among the “baby boomer plus” population (people born in 1946-1970) in the United States may be higher than expected. “A screening strategy based on age, rather than risk factors, could have a significant impact” on the disease, he said.
Dr. Younossi and colleagues used a Markov model of the natural history of the infection and its complications. They applied the model to a population of approximately 102 million individuals who were eligible for screening, and found that the birth cohort screening (BCS) strategy would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer cases of advanced liver disease, compared with the current risk-based screening (RBS) strategy.
The investigators designed a mathematical model using a birth cohort of individuals who were born in the United States in 1946-1970. They estimated the current hepatitis C status and stage of disease progression using a run-in period from 1964 to 2010, as well as using age- and sex-based rates of infection, progression, and spontaneous clearance. BCS involved the assumption that 100% of the cohort would be screened within the first 5 years, starting in 2010.
The model suggested that BCS would cost approximately $25,000 for each additional quality-adjusted year of life gained. BCS would cost more overall than RBS ($45.1 billion vs. 32.0 billion), but BCS would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion), Dr. Younossi said. The up-front investment could be worthwhile in terms of reducing long-term medical costs, he said.
“There are better hepatitis C treatments in development that could increase the benefits of screening,” Dr. Younossi said. Effective screening for hepatitis C now may reduce future costs to Medicare, he added.
I have checked the following facts in my story: (Please initial each.)
The study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on advisory committees or review panels for multiple pharmaceutical companies, including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec.
*This story has been updated and new information has been added.
FROM THE ANNUAL DIGESTIVE DISEASE WEEK
Major Finding: BCS
would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer
cases of advanced liver disease, compared with RBS.
Data Source:
Investigators applied a Markov model to a population of approximately 102
million individuals who were eligible for HCV screening.
Disclosures: The
study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on
advisory committees or review panels for multiple pharmaceutical companies,
including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec.
Age-Based Hep C Screening May Work Better Than Risk-Based Screening
CHICAGO - A targeted, age-based screening program would result in 59,000 fewer deaths associated with hepatitis C and advanced liver disease, compared with the current risk-based screening program, based on statistical modeling.
Under current U.S. screening practices, “people with no risk factors might not get screened,” Dr. Zobair Younossi of the Inova Health System in Fairfax, Va., said during a press conference in advance of the meetingannual Digestive Disease Week. The results were presented at the annual Digestive Disease Week meeting on May 8.
Individuals with hepatitis C may not show symptoms until decades after they have been infected, he noted. Recent studies have shown that the prevalence of hepatitis C virus (HCV) infection among the “baby boomer plus” population (people born in 1946-1970) in the United States may be higher than expected. “A screening strategy based on age, rather than risk factors, could have a significant impact” on the disease, he said.
Dr. Younossi and colleagues used a Markov model of the natural history of the infection and its complications. They applied the model to a population of approximately 102 million individuals who were eligible for screening, and found that the birth cohort screening (BCS) strategy would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer cases of advanced liver disease, compared with the current risk-based screening (RBS) strategy.
The investigators designed a mathematical model using a birth cohort of individuals who were born in the United States in 1946-1970. They estimated the current hepatitis C status and stage of disease progression using a run-in period from 1964 to 2010, as well as using age- and sex-based rates of infection, progression, and spontaneous clearance. BCS involved the assumption that 100% of the cohort would be screened within the first 5 years, starting in 2010.
The model suggested that BCS would cost approximately $25,000 for each additional quality-adjusted year of life gained. BCS would cost more overall than RBS ($45.1 billion vs. 32.0 billion), but BCS would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion), Dr. Younossi said. The up-front investment could be worthwhile in terms of reducing long-term medical costs, he said.
“There are better hepatitis C treatments in development that could increase the benefits of screening,” Dr. Younossi said. Effective screening for hepatitis C now may reduce future costs to Medicare, he added.
I have checked the following facts in my story: (Please initial each.)
The study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on advisory committees or review panels for multiple pharmaceutical companies, including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec.
*This story has been updated and new information has been added.
It seems intuitive
that screening a cohort of patients, in this case those born between 1946 and
1964, for hepatitis C virus (HCV) infection, treating the ones infected, and
then following them for the next 6 to 34 years (until they reach age 70 years)
should find that the eventual prevalence of complications of end-stage liver
disease would be reduced when compared to the same cohort of patients only
tested for HCV infection when a risk factor for HCV infection is identified.
But how does this information help me as an individual practitioner? Should I
now screen all the “baby boomers” in my practice whether I have identified a
past risk for HCV infection or not? What about patients in other age cohorts?
And how do I reconcile this against the recommendation of the U.S. Preventive
Services Task Force that has yet to change its stand that the available data
doesn’t support HCV screening of high-risk individuals?
One thing that I
believe it does tell me is that we don’t always ask the right questions of our
patients and that patients don’t always remember or tell us about things of the
past that have put them at risk for HCV. Sometimes I simply show my patients a
list of risks and only ask if there is something on the list that might be
true. It saves them from having to own up to a specific event and yet it lets
me know they are at risk and should be screened. I wonder how that approach
would fare when studied.
Rowen K. Zetterman, M.D. is an internist
and gastroenterologist and dean of the Creighton
University School
of Medicine in Omaha, Neb. He serves on the editorial advisory
board for Internal
Medicine News. He reported having no conflicts of interest.
It seems intuitive
that screening a cohort of patients, in this case those born between 1946 and
1964, for hepatitis C virus (HCV) infection, treating the ones infected, and
then following them for the next 6 to 34 years (until they reach age 70 years)
should find that the eventual prevalence of complications of end-stage liver
disease would be reduced when compared to the same cohort of patients only
tested for HCV infection when a risk factor for HCV infection is identified.
But how does this information help me as an individual practitioner? Should I
now screen all the “baby boomers” in my practice whether I have identified a
past risk for HCV infection or not? What about patients in other age cohorts?
And how do I reconcile this against the recommendation of the U.S. Preventive
Services Task Force that has yet to change its stand that the available data
doesn’t support HCV screening of high-risk individuals?
One thing that I
believe it does tell me is that we don’t always ask the right questions of our
patients and that patients don’t always remember or tell us about things of the
past that have put them at risk for HCV. Sometimes I simply show my patients a
list of risks and only ask if there is something on the list that might be
true. It saves them from having to own up to a specific event and yet it lets
me know they are at risk and should be screened. I wonder how that approach
would fare when studied.
Rowen K. Zetterman, M.D. is an internist
and gastroenterologist and dean of the Creighton
University School
of Medicine in Omaha, Neb. He serves on the editorial advisory
board for Internal
Medicine News. He reported having no conflicts of interest.
It seems intuitive
that screening a cohort of patients, in this case those born between 1946 and
1964, for hepatitis C virus (HCV) infection, treating the ones infected, and
then following them for the next 6 to 34 years (until they reach age 70 years)
should find that the eventual prevalence of complications of end-stage liver
disease would be reduced when compared to the same cohort of patients only
tested for HCV infection when a risk factor for HCV infection is identified.
But how does this information help me as an individual practitioner? Should I
now screen all the “baby boomers” in my practice whether I have identified a
past risk for HCV infection or not? What about patients in other age cohorts?
And how do I reconcile this against the recommendation of the U.S. Preventive
Services Task Force that has yet to change its stand that the available data
doesn’t support HCV screening of high-risk individuals?
One thing that I
believe it does tell me is that we don’t always ask the right questions of our
patients and that patients don’t always remember or tell us about things of the
past that have put them at risk for HCV. Sometimes I simply show my patients a
list of risks and only ask if there is something on the list that might be
true. It saves them from having to own up to a specific event and yet it lets
me know they are at risk and should be screened. I wonder how that approach
would fare when studied.
Rowen K. Zetterman, M.D. is an internist
and gastroenterologist and dean of the Creighton
University School
of Medicine in Omaha, Neb. He serves on the editorial advisory
board for Internal
Medicine News. He reported having no conflicts of interest.
CHICAGO - A targeted, age-based screening program would result in 59,000 fewer deaths associated with hepatitis C and advanced liver disease, compared with the current risk-based screening program, based on statistical modeling.
Under current U.S. screening practices, “people with no risk factors might not get screened,” Dr. Zobair Younossi of the Inova Health System in Fairfax, Va., said during a press conference in advance of the meetingannual Digestive Disease Week. The results were presented at the annual Digestive Disease Week meeting on May 8.
Individuals with hepatitis C may not show symptoms until decades after they have been infected, he noted. Recent studies have shown that the prevalence of hepatitis C virus (HCV) infection among the “baby boomer plus” population (people born in 1946-1970) in the United States may be higher than expected. “A screening strategy based on age, rather than risk factors, could have a significant impact” on the disease, he said.
Dr. Younossi and colleagues used a Markov model of the natural history of the infection and its complications. They applied the model to a population of approximately 102 million individuals who were eligible for screening, and found that the birth cohort screening (BCS) strategy would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer cases of advanced liver disease, compared with the current risk-based screening (RBS) strategy.
The investigators designed a mathematical model using a birth cohort of individuals who were born in the United States in 1946-1970. They estimated the current hepatitis C status and stage of disease progression using a run-in period from 1964 to 2010, as well as using age- and sex-based rates of infection, progression, and spontaneous clearance. BCS involved the assumption that 100% of the cohort would be screened within the first 5 years, starting in 2010.
The model suggested that BCS would cost approximately $25,000 for each additional quality-adjusted year of life gained. BCS would cost more overall than RBS ($45.1 billion vs. 32.0 billion), but BCS would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion), Dr. Younossi said. The up-front investment could be worthwhile in terms of reducing long-term medical costs, he said.
“There are better hepatitis C treatments in development that could increase the benefits of screening,” Dr. Younossi said. Effective screening for hepatitis C now may reduce future costs to Medicare, he added.
I have checked the following facts in my story: (Please initial each.)
The study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on advisory committees or review panels for multiple pharmaceutical companies, including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec.
*This story has been updated and new information has been added.
CHICAGO - A targeted, age-based screening program would result in 59,000 fewer deaths associated with hepatitis C and advanced liver disease, compared with the current risk-based screening program, based on statistical modeling.
Under current U.S. screening practices, “people with no risk factors might not get screened,” Dr. Zobair Younossi of the Inova Health System in Fairfax, Va., said during a press conference in advance of the meetingannual Digestive Disease Week. The results were presented at the annual Digestive Disease Week meeting on May 8.
Individuals with hepatitis C may not show symptoms until decades after they have been infected, he noted. Recent studies have shown that the prevalence of hepatitis C virus (HCV) infection among the “baby boomer plus” population (people born in 1946-1970) in the United States may be higher than expected. “A screening strategy based on age, rather than risk factors, could have a significant impact” on the disease, he said.
Dr. Younossi and colleagues used a Markov model of the natural history of the infection and its complications. They applied the model to a population of approximately 102 million individuals who were eligible for screening, and found that the birth cohort screening (BCS) strategy would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer cases of advanced liver disease, compared with the current risk-based screening (RBS) strategy.
The investigators designed a mathematical model using a birth cohort of individuals who were born in the United States in 1946-1970. They estimated the current hepatitis C status and stage of disease progression using a run-in period from 1964 to 2010, as well as using age- and sex-based rates of infection, progression, and spontaneous clearance. BCS involved the assumption that 100% of the cohort would be screened within the first 5 years, starting in 2010.
The model suggested that BCS would cost approximately $25,000 for each additional quality-adjusted year of life gained. BCS would cost more overall than RBS ($45.1 billion vs. 32.0 billion), but BCS would yield lower costs related to advanced liver disease ($21.7 billion vs. $25.8 billion), Dr. Younossi said. The up-front investment could be worthwhile in terms of reducing long-term medical costs, he said.
“There are better hepatitis C treatments in development that could increase the benefits of screening,” Dr. Younossi said. Effective screening for hepatitis C now may reduce future costs to Medicare, he added.
I have checked the following facts in my story: (Please initial each.)
The study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on advisory committees or review panels for multiple pharmaceutical companies, including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec.
*This story has been updated and new information has been added.
FROM THE ANNUAL DIGESTIVE DISEASE WEEK
Major Finding: BCS
would result in 59,000 fewer deaths related to HCV infection and 106,000 fewer
cases of advanced liver disease, compared with RBS.
Data Source:
Investigators applied a Markov model to a population of approximately 102
million individuals who were eligible for HCV screening.
Disclosures: The
study was supported by Vertex Pharmaceuticals. Dr. Younossi has served on
advisory committees or review panels for multiple pharmaceutical companies,
including Vertex Pharmaceuticals, Salix Pharmaceuticals, and Tibotec.
Moderate Exercise Can Reduce Colon Polyps by One-Third
In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.
"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.
Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).
The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).
About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).
In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.
Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.
When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.
These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.
The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.
Dr. Sanchez said he had no financial conflicts to disclose.
In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.
"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.
Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).
The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).
About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).
In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.
Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.
When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.
These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.
The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.
Dr. Sanchez said he had no financial conflicts to disclose.
In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.
"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.
Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).
The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).
About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).
In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.
Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.
When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.
These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.
The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.
Dr. Sanchez said he had no financial conflicts to disclose.
FROM THE ANNUAL DIGESTIVE DISEASE WEEK
Major Finding: Prevalence of polyps was significantly higher among patients who reported less
than 1 hour per week of exercise, compared with those who reported
exercising for 1 hour or more (33.2% vs. 25.3%).
Data Source: A prospective study of 982 middle-aged adults, all with an average risk for colorectal cancer.
Disclosures: Dr. Sanchez said he had no financial conflicts to disclose.
Moderate Exercise Can Reduce Colon Polyps by One-Third
In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.
"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.
Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).
The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).
About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).
In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.
Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.
When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.
These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.
The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.
Dr. Sanchez said he had no financial conflicts to disclose.
In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.
"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.
Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).
The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).
About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).
In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.
Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.
When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.
These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.
The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.
Dr. Sanchez said he had no financial conflicts to disclose.
In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.
"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.
Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).
The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).
About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).
In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.
Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.
When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.
These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.
The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.
Dr. Sanchez said he had no financial conflicts to disclose.
FROM THE ANNUAL DIGESTIVE DISEASE WEEK
Moderate Exercise Can Reduce Colon Polyps by One-Third
In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.
"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.
Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).
The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).
About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).
In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.
Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.
When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.
These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.
The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.
Dr. Sanchez said he had no financial conflicts to disclose.
In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.
"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.
Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).
The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).
About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).
In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.
Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.
When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.
These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.
The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.
Dr. Sanchez said he had no financial conflicts to disclose.
In a prospective study of multiple ethnic groups, people with at least 1 hour of moderate physical activity per week had a one-third lower risk of colon polyps.
"One thing that was new and exciting about our research was that the ethnic diversity in our population was different" from that of other studies, Dr. Nelson Sanchez of Memorial Sloan-Kettering Cancer Center, New York, said during a press conference in advance of the annual Digestive Disease Week. The findings were presented at the meeting on May 8.
Of the 982 middle-aged adults who enrolled in the study, 558 (57%) were Hispanic, 202 (21%) were Asian, 149 (15%) were black, and 69 (7%) were white. A total of 603 participants (61%) had a body mass index that was categorized as overweight or obese (25 kg/m2 or greater).
The participants all had average risk for colorectal cancer, and the polyps were identified during screening colonoscopy. The overall prevalence of colon polyps was 29.5%, but the prevalence was significantly higher among patients who reported less than 1 hour per week of exercise, compared with those who reported exercising for 1 hour or more (33.2% vs. 25.3%, respectively); this difference was statistically significant (P = .008).
About half of the participants (513 individuals, or 52%) reported that they exercise for at least 1 hour per week, and the median duration of this activity level was 5 years (range, 1.5-10 years).
In addition, the researchers looked at risk for adenomas, which can be precursors of colorectal cancer, particularly if they are advanced adenomas. Those participants who exercised for 1 or more hours weekly had an adenoma prevalence of 14%, compared with 19% in those who exercised less than 1 hour a week, said Dr. Sanchez.
Also, overweight and obese patients who exercised at least 1 hour per week were 40% less likely to have any adenomas, and 63% less likely to have advanced adenomas than were overweight or obese individuals who exercised less, the researchers noted.
When the data were analyzed by race/ethnicity, the odds of having advanced adenomas greater than 1 cm in size or having colorectal cancers were lowest for blacks who exercised for at least 1 hour each week (odds ratio, 0.16). In addition, the odds ratio for adenomas was cut in half (0.47) for Hispanics who exercised for at least 1 hour each week, compared with Hispanics who exercised less.
These results could have a substantial public health impact, as they suggest that even a moderate level of exercise may reduce polyp risk in a diverse population, said Dr. Sanchez. "Even low levels of physical activity have been shown to confer protective benefits," he noted.
The next steps for researchers include identifying which specific physical activities and what level of intensity convey the most protection from colon polyps, Dr. Sanchez added.
Dr. Sanchez said he had no financial conflicts to disclose.
FROM THE ANNUAL DIGESTIVE DISEASE WEEK
Major Finding: Prevalence of polyps was significantly higher among patients who reported less
than 1 hour per week of exercise, compared with those who reported
exercising for 1 hour or more (33.2% vs. 25.3%).
Data Source: A prospective study of 982 middle-aged adults, all with an average risk for colorectal cancer.
Disclosures: Dr. Sanchez said he had no financial conflicts to disclose
Obesity Screening of Younger Children Leads to Better BMI, Lipids
Intensive lifestyle intervention after obesity screening significantly improved body mass index z scores in children aged 2-5 years, compared with children aged 6-21 years, based on data from 462 children enrolled in a tertiary-care clinical obesity program.
"Children 2 to 5 years old responded nearly seven times more favorably than [did] older children aged 6 to 21 years old after completion of 6 months within our obesity program," Dr. Carl A. Sather of Indiana University, Indianapolis, said in a press conference. The complete study findings will be presented on May 9 at the annual Digestive Disease Week.
The findings contrast with the current U.S. Preventive Services Task Force guidelines, which suggest screening children aged 6-18 years (not younger) for obesity and referring them for comprehensive therapy if needed, he said.
The study population included 44 children aged 2-5 years and 418 children and adolescents aged 6-21 years. All participants were referred to the program and had a body mass index above the 95th percentile for age and sex, or had a BMI greater than the 85th percentile with comorbidities.
During the lifestyle intervention, changes in BMI z scores were significantly greater in the younger group, compared with the older group after 3 months (–0.23 vs. –0.05) and after 6 months (–0.64 vs. –0.094).
The 12-month program began with a 3-month clinic-based intervention that included sessions with a dietitian, physical therapist, child psychologist, and pediatrician. Children and their caregivers were taught behavior change techniques including goal setting, accountability, self-monitoring, and stimulus control.
The children and caregivers met in group sessions once a month during months 4-6 and bimonthly during months 7-12. Interventions included the use of a food journal and a pedometer. Program completion rates were similar between the younger and older groups at 3 months (43% vs. 44%) and 6 months (11% vs. 14%).
The mean age of the younger patients was 4.6 years, with a mean BMI z score at baseline of 3.46. The mean age of the older patients was 12.2 years, with a mean BMI z score at baseline of 2.55.
The baseline rate of dyslipidemia (HDL cholesterol less than 40 mg/dL) was similar in the younger vs. older groups (56% vs. 59%, respectively), and the baseline rate of transaminitis, or elevated levels of aspartate transaminase and alanine transaminase, also was similar for the two groups (7% vs. 7.5%, respectively). Follow-up lab testing for dyslipidemia at 6-12 months showed similar gains in HDL in both the younger and older groups (increases of 2.84 mg/dL vs. 2.00 mg/dL, respectively).
Although the findings suggest that obesity screening is appropriate for preschoolers, it is important for the parent or caregiver to monitor the use of pedometers and food/activity journals by the youngest children, Dr. Sather noted in an interview.
"We had to take some specific strategies to address developmental limitations in the 2- to 3-year-old group," he said. But pedometers can be used by children if they are monitored by adults, and the food and activity journal also can be used easily by young children with adult supervision, he said.
"We don’t see any reason that younger children should be excluded from behavioral interventions [for obesity]" said Dr. Sather. "Although our numbers are small, our completion rate is consistent with other centers," he said, and the data are sufficiently convincing to recommend that all children aged 2-18 years should receive obesity screening, similar to the American Academy of Pediatrics’ current recommendations. "We hope that our data will prompt some further research and examine the positive impacts of BMI screening at younger ages, and that it will contribute to stronger conclusions and healthier pediatric populations," he said.
Dr. Sather said he had no financial conflicts to disclose.
Intensive lifestyle intervention after obesity screening significantly improved body mass index z scores in children aged 2-5 years, compared with children aged 6-21 years, based on data from 462 children enrolled in a tertiary-care clinical obesity program.
"Children 2 to 5 years old responded nearly seven times more favorably than [did] older children aged 6 to 21 years old after completion of 6 months within our obesity program," Dr. Carl A. Sather of Indiana University, Indianapolis, said in a press conference. The complete study findings will be presented on May 9 at the annual Digestive Disease Week.
The findings contrast with the current U.S. Preventive Services Task Force guidelines, which suggest screening children aged 6-18 years (not younger) for obesity and referring them for comprehensive therapy if needed, he said.
The study population included 44 children aged 2-5 years and 418 children and adolescents aged 6-21 years. All participants were referred to the program and had a body mass index above the 95th percentile for age and sex, or had a BMI greater than the 85th percentile with comorbidities.
During the lifestyle intervention, changes in BMI z scores were significantly greater in the younger group, compared with the older group after 3 months (–0.23 vs. –0.05) and after 6 months (–0.64 vs. –0.094).
The 12-month program began with a 3-month clinic-based intervention that included sessions with a dietitian, physical therapist, child psychologist, and pediatrician. Children and their caregivers were taught behavior change techniques including goal setting, accountability, self-monitoring, and stimulus control.
The children and caregivers met in group sessions once a month during months 4-6 and bimonthly during months 7-12. Interventions included the use of a food journal and a pedometer. Program completion rates were similar between the younger and older groups at 3 months (43% vs. 44%) and 6 months (11% vs. 14%).
The mean age of the younger patients was 4.6 years, with a mean BMI z score at baseline of 3.46. The mean age of the older patients was 12.2 years, with a mean BMI z score at baseline of 2.55.
The baseline rate of dyslipidemia (HDL cholesterol less than 40 mg/dL) was similar in the younger vs. older groups (56% vs. 59%, respectively), and the baseline rate of transaminitis, or elevated levels of aspartate transaminase and alanine transaminase, also was similar for the two groups (7% vs. 7.5%, respectively). Follow-up lab testing for dyslipidemia at 6-12 months showed similar gains in HDL in both the younger and older groups (increases of 2.84 mg/dL vs. 2.00 mg/dL, respectively).
Although the findings suggest that obesity screening is appropriate for preschoolers, it is important for the parent or caregiver to monitor the use of pedometers and food/activity journals by the youngest children, Dr. Sather noted in an interview.
"We had to take some specific strategies to address developmental limitations in the 2- to 3-year-old group," he said. But pedometers can be used by children if they are monitored by adults, and the food and activity journal also can be used easily by young children with adult supervision, he said.
"We don’t see any reason that younger children should be excluded from behavioral interventions [for obesity]" said Dr. Sather. "Although our numbers are small, our completion rate is consistent with other centers," he said, and the data are sufficiently convincing to recommend that all children aged 2-18 years should receive obesity screening, similar to the American Academy of Pediatrics’ current recommendations. "We hope that our data will prompt some further research and examine the positive impacts of BMI screening at younger ages, and that it will contribute to stronger conclusions and healthier pediatric populations," he said.
Dr. Sather said he had no financial conflicts to disclose.
Intensive lifestyle intervention after obesity screening significantly improved body mass index z scores in children aged 2-5 years, compared with children aged 6-21 years, based on data from 462 children enrolled in a tertiary-care clinical obesity program.
"Children 2 to 5 years old responded nearly seven times more favorably than [did] older children aged 6 to 21 years old after completion of 6 months within our obesity program," Dr. Carl A. Sather of Indiana University, Indianapolis, said in a press conference. The complete study findings will be presented on May 9 at the annual Digestive Disease Week.
The findings contrast with the current U.S. Preventive Services Task Force guidelines, which suggest screening children aged 6-18 years (not younger) for obesity and referring them for comprehensive therapy if needed, he said.
The study population included 44 children aged 2-5 years and 418 children and adolescents aged 6-21 years. All participants were referred to the program and had a body mass index above the 95th percentile for age and sex, or had a BMI greater than the 85th percentile with comorbidities.
During the lifestyle intervention, changes in BMI z scores were significantly greater in the younger group, compared with the older group after 3 months (–0.23 vs. –0.05) and after 6 months (–0.64 vs. –0.094).
The 12-month program began with a 3-month clinic-based intervention that included sessions with a dietitian, physical therapist, child psychologist, and pediatrician. Children and their caregivers were taught behavior change techniques including goal setting, accountability, self-monitoring, and stimulus control.
The children and caregivers met in group sessions once a month during months 4-6 and bimonthly during months 7-12. Interventions included the use of a food journal and a pedometer. Program completion rates were similar between the younger and older groups at 3 months (43% vs. 44%) and 6 months (11% vs. 14%).
The mean age of the younger patients was 4.6 years, with a mean BMI z score at baseline of 3.46. The mean age of the older patients was 12.2 years, with a mean BMI z score at baseline of 2.55.
The baseline rate of dyslipidemia (HDL cholesterol less than 40 mg/dL) was similar in the younger vs. older groups (56% vs. 59%, respectively), and the baseline rate of transaminitis, or elevated levels of aspartate transaminase and alanine transaminase, also was similar for the two groups (7% vs. 7.5%, respectively). Follow-up lab testing for dyslipidemia at 6-12 months showed similar gains in HDL in both the younger and older groups (increases of 2.84 mg/dL vs. 2.00 mg/dL, respectively).
Although the findings suggest that obesity screening is appropriate for preschoolers, it is important for the parent or caregiver to monitor the use of pedometers and food/activity journals by the youngest children, Dr. Sather noted in an interview.
"We had to take some specific strategies to address developmental limitations in the 2- to 3-year-old group," he said. But pedometers can be used by children if they are monitored by adults, and the food and activity journal also can be used easily by young children with adult supervision, he said.
"We don’t see any reason that younger children should be excluded from behavioral interventions [for obesity]" said Dr. Sather. "Although our numbers are small, our completion rate is consistent with other centers," he said, and the data are sufficiently convincing to recommend that all children aged 2-18 years should receive obesity screening, similar to the American Academy of Pediatrics’ current recommendations. "We hope that our data will prompt some further research and examine the positive impacts of BMI screening at younger ages, and that it will contribute to stronger conclusions and healthier pediatric populations," he said.
Dr. Sather said he had no financial conflicts to disclose.
FROM DIGESTIVE DISEASE WEEK
Major Finding: Lifestyle intervention after obesity screening led to significantly greater reductions in body mass index among children aged 2-5 years, compared to children aged 6-21 years.
Data Source: Data from 462 obese children aged 2-21 years.
Disclosures: Dr. Sather said he had no financial conflicts to disclose.
Type 2 Diabetes Patients on Medication Report High Rates of Hypoglycemia
SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.
"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.
Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).
The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.
Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.
Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.
The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.
The study was supported by AstraZeneca.
SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.
"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.
Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).
The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.
Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.
Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.
The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.
The study was supported by AstraZeneca.
SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.
"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.
Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).
The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.
Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.
Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.
The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.
The study was supported by AstraZeneca.
FROM THE ANNUAL MEETING OF THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS
Major Finding: Among type 2 diabetes patients taking insulin, 40%-43% reported having an episode of hypoglycemia in the past month, regardless of whether they took oral antidiabetes medications.
Data Source: A survey of 2,801 adults who had been treated for type 2 diabetes for at least 12 months.
Disclosures: The study was supported by AstraZeneca.
Type 2 Diabetes Patients on Medication Report High Rates of Hypoglycemia
SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.
"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.
Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).
The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.
Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.
Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.
The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.
The study was supported by AstraZeneca.
SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.
"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.
Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).
The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.
Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.
Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.
The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.
The study was supported by AstraZeneca.
SAN DIEGO – Regardless of whether they take oral diabetes medications, roughly 40%-43% of type 2 diabetes patients who took insulin reported having hypoglycemia in the past month, according to survey findings from 2,801 adults.
"Hypoglycemia is a leading limiting factor in the glycemic management of adults with type 2 diabetes mellitus who are treated with insulin or a sulfonylurea agent," Dr. Andrew Green said at the annual meeting of the American Association of Clinical Endocrinologists. The findings suggest a need to consider the risk of hypoglycemia as part of a risk-versus-benefit analysis when designing a treatment regimen for type 2 diabetes patients, he added.
Of the survey respondents who received oral medications, 52% reported receiving sulfonylureas. And among those patients using sulfonylureas for the past 12 months, significantly more of them reported having hypoglycemia during the past month than did those who did not receive sulfonylureas (28% vs. 19%).
The 5-year population-based survey, known as the Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) was initiated in 2005.
Overall, 1,793 patients (64%) received oral medication only, 221 (8%) received insulin only, 361 (13%) received both types of therapy, and 426 (15%) were not receiving any diabetes treatment at the time of the survey. The average ages of the patients in group ranged from 61 to 65 years; more than 70% of the patients in each group were white, and more than half (58%-64%) were women, said Dr. Green, an endocrinologist in Overland Park, Kansas.
Patients who received both insulin and oral medications were significantly more likely to be younger and obese compared with those who received either type of treatment alone.
The study was limited by the use of self-reports and the lack of data on the severity and causes of hypoglycemia.
The study was supported by AstraZeneca.
FROM THE ANNUAL MEETING OF THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS